NEW COMPLEMENTARY TREATMENT FOR PSORIASIS
MICHAEL TIRANT, AUSTRALIA *

*TRIALS WERE CONDUCTED AT DEPARTMENT OF DERMATOLOGY, SEMMELWEIS UNIVERSITY, BUDAPEST AND AT DEPARTMENT OF DERMATOLOGY, KOLOZSVAR-ROMANIA

Psoriasis is a common chronic, recurring skin disease. Genetic predispositions as well as provoking factors play a role in its etiology. The clinical prevention is variable. There are multiple topical and systemic treatment options available in certain clinical presentations the topical therapy is sufficient.

The study of the topical product family was designed to determine whether it’s natural all content (the composition and ratio of the natural oils) was able to reduce the psoriatic parakeratosis, inflammation and infiltration.

STUDY TYPE: Open

CONSENT: Prior to the beginning of the study. The participating patients signed an informed consent and an agreement of voluntary participation.

OBJECTIVE: Evaluation of the topical product family in psoriasis, to determine its efficacy, adverse effects and tolerability.

CHARACTERISTICS OF THE TESTED PRODUCT

Triphasic application: Successive use of a cleansing gel, ointment and skin conditioner.

CLEANSING GEL

COMPONENTS: water, coal tar solution, sodium lauryl ether sulfate, coco amido propyl betaine, triethanolamine lauryl sulfate, organic acids, fruit acid complex, coconut diethanolamide, carbopol, triethanolamine, methylprednisolone, —— IDIA.

APPLICATION: Applied before the use of the ointment.

SCALP: Following wetting of the scalp, a small amount of cleansing gel was applied to the plaques. Washed off after 2-3 minutes using lukewarm water.

BODY: Applied to the psoriatic plaques, washed off with lukewarm water after 2-3 minutes. Not to be applied to the face.

OINTMENT

COMPONENTS: wheatgerm oil, sweat almond oil, evening primrose oil, pet jelly, sine oxide, apricot kernel oil, avocado oil, mineral oil, carrageenins, carrot oil, fruit acid complex, lavender oil, tea tree oil, bergamot oil, underwood oil, patchouli oil, pine oil, geranium oil, orange oil, neroli oil, calendula oil, frankincense oil, acomplia oil, chickweed extract, chamomile extract, sesame seed oil, myrrh oil, preservatives.

APPLICATION: Applied to the psoriasis plaque of the scalp and body after using and washing off the cleansing gel. Ointment was applied only to severely infiltrated plaques on the scalp 

SKIN CONDITIONER

COMPONENTS: olive oil, sesame seed oil, mineral oil, dermidex, sunflower oil, emu oil, lavender oil, eucalyptus oil, rosemary oil, natural vitamin E, chickweed extract, calendula oil, preservatives.

APPLICATION: Applied to the psoriatic plaques two minutes after using the ointment (without washing it off).

APPLICATION TO THE SCALP WITHOUT OINTMENT: The conditioner was applied to the scalp at night and washed off in the morning using the cleansing gel. The conditioner was reapplied at night without washing the scalp and washed off again using the cleansing gel in the morning. It was recommended to apply the three component product family twice daily, in the morning and at night 

PATIENT EVALUATION

INCLUSION CRITERIA

• Mild to moderately user psoriasis without complication
• Both genders, age above 18
• No other current anti-psoriatic therapy
• Signed informed consent

EXCLUSION CRITERIA

• Particular erythrodermic psoriasis
• Systemic, acitretin, cyclosporine, methotrexate, light therapy currently or within the past 3 months
• Topical anti-psoriatic therapy
• Pregnancy, breastfeeding
• Known hypersensitivity to any of the components of the products
• Lack of informed consent
• Low compliance

Not be applied to the face, genitals and ——-

STUDY PROTOCOL

TIME FRAME

2 weeks of washout period. During this phase the patient used only enrollents.

Application time of the products:                6 weeks

Total study length:                                         8 weeks

EVALUATION POINTS                     -1, 0, 1, 2, 3, 4, 5, 6 weeks

Total number of medical evaluation             8

Patients included                                             62

Patients excluded                                            5

Patients evaluated, completed                    57

Application frequency                                    twice daily

EVALUATION OF EFFICACY: The evaluation was based on the Psoriasis Area and Severity Index (PASI) at each 8 medical evaluations.

EVALUATION OF IMPROVEMENT

Worsened                                           PASI score higher than baseline

No improvement                               PASI decreased 0-25%

Moderate improvement                   PASI decreased 26-50%

Good improvement                           PASI decreased 51-75%

Outstanding improvement              PASI decreased 76-100%

RECORDING OF SIDE EFFECTS

The recording of side effects began on 3 weeks. The characteristics of side effects, their relation to the product and the additional steps taken were recorded on the datasheet.

EVALUATION OF SIDE EFFECTS

Evaluation points of side effects:              1, 2, 3, 4, 5, 6 weeks

EVALUATION OF THE RESULTS

COSMETIC EFFECTS tolerably was evaluated all the end of the study based on the statements of the patients.

EFFICACY was evaluated by the physician by the end of the study using the following description monitored, ineffective, moderate effect, good effect, outstanding effect. The physician evaluation was based on the percentage change of the PASI scores.

SUMMARY

The study was completed in 57 patients. Five patients dropped out four due to lack of compliance and one due to the retraction of informed consent. The patient in the trial had mild to moderately severe psoriasis.

The product proved to be ineffective in five of the 57 patients (9%). 11 patients (15%) had moderate improvement. 25-50% of the skin lesions cleared up. 11 patients (19%) had good improvement. 51-75% of the lesions disappeared. 20 patients (53%) showed outstanding improvement with regression of 76-99% of the lesions.

23% of the patients developed folliculitis as side effect that was clearly related to the product family. The folliculitis was noted as a few treated plaques and the surrounding areas on the lower extremities. In all cases the folliculitis regressed upon discontinuation of the application without further treatment. In one case the folliculitis cleared after topical therapy. 5% of the patients developed pruritis, which regressed without discontinuing the application.

No contact sensitization was noted, which is probably due to the thorough screening applied during patient selection.

Although this product was cosmetic, due to previously described circumstances it was recommended that the patients seek the advice of a dermatologist before starting the application in case of noticing side effects the patients should consult a dermatologist.

The cosmetic effect was evaluated as indifferent by 49% of the patients, as good by 35% of the patients and as excellent by 16% of the patients.

The evaluation of the treatment by the patients differs from that by the physician. The physician considered the improvement ‘outstanding’ in 53% of the cases, while the patients considered it ‘outstanding’ in 33% of the cases. The differences can be explained by the fact that the physician’s evaluation was based on a pre-determined scale and calculation of percentage changes, while the patients’ evaluation was entirely subjective. The patients considered the improvement ‘good’ when it was only moderate based on the calculated scores. However, many patients would only have given ‘outstanding’ evaluation for complete clearing of the lesions

95% of the patients stated that they would continue to use the product, including those who had only moderate improvement. They argued that they were less concerned about side effects since the product was a cosmetic not a medication.

BASED ON THE RESULTS OF THIS STUDY, THE NEW COMPLEMENTARY TREATMENT CAN BE SUCCESSFULLY APPLIED IN MILD TO MODERATELY SEVERE PSORIASIS.

REPORT ON THE STUDY OF THE ‘DR. MICHAELS’ TOPICAL PRODUCT FAMILY IN PSORIASIS

Lead investigator:                Prof. Dr. Attila Horvath

Institution:                             Semmelweis University Dept. of Dermato-Venereology

Budapest, Maria u. 41 – H – 1085 Budapest – Tel.: (36) 1 266-0465 – Fax: (36) 1 267-6974

Study type:                            Open

TUKEB permit number:       26/2002

OETI permit number:           6060/2001

Consent:                                Prior to the beginning of the study, the participating patients signed an informed consent and an agreement of voluntary participation.

I. GENERAL POINTS

1. BACKGROUND

Psoriasis is a common (approximate prevalence of 2% in Hungary) chronic, recurring skin disease. Genetic predisposition as well as triggering factors play role in its etiology. The disease can occur at any age without any gender predominance. Although psoriasis can affect any regions of the body there are areas more frequently involved, such as the scalp, extensor surfaces of the extremities, skin folds, nails. The clinical presentation is variable, characterized by infiltration and parakeratosis. There are multiple topical and systemic treatment options available. In certain clinical presentations the topical anti-psoriasis therapy is sufficient.

REPORTOF THE STUDY OF THE ‘DR. MICHAELS’ TOPICAL PRODUCT FAMILY IN PSORIASIS

Lead investigator:                Prof. Dr. Attila Horvath

Institution:                             Semmelweis University Dept. of Dermato • Venereology

H • 1085 Budapest, Maria utca 41

Study type:                            Open

TUKEB permit number:       26/2002

OETI permit number:           6060/2001

Consent:                                Prior to the beginning of the study, the participating patients signed an informed consent and an agreement of voluntary participation.

I. GENERAL POINTS

1. BACKGROUND

Psoriasis is a common (approximate prevalence of 2% in Hungary) chronic, recurring skin disease. Genetic predisposition as well as triggering factors play role in its etiology. The disease can occur at any age without any gender predominance. Although psoriasis can affect any regions of the body there are areas more frequently involved, such as the scalp, extensor surfaces of the extremities, skin folds, nails. The clinical presentation is variable, characterized by infiltration and parakeratosis. There are multiple topical and systemic treatment options available. In certain clinical presentations the topical anti-psoriasis therapy is sufficient.

The study of the Dr. Michaels topical product family was designed to determine whether its natural oil content (the composition and ratio of the natural oils) was able to decrease the psoriatic parakeratosis, inflammation, and infiltration.

2. OBJECTIVE

Evaluation of the Dr. Michaels topical product family in psoriasis to determine its efficacy, adverse effects, and tolerability.

3. CHARACTERISTICS OF THE TESTED PRODUCT

Triphasic application: Successive use of a cleansing gel (Cleansing Gel – Scalp and Body), ointment (Scalp and body ointment), and skin conditioner (Skin conditioner).

3.1 Dr. Michaels cleansing gel for the scalp and body

Loose, white-opaque, easily applicable topical preparation.

Effect: decreases parakeratosis

Components: water, coal tar solution, sodium lauryl ether sulfate, coco amido dipropyl betaine, triethanolamine lauryl sulphate, organic acids, fruit acid complex, coconut diethanolamide, carbopol, triethanolamine, methylchloroisothiazolinone (and) methylisothiazolinone, tertasodium EDTA.

Application: Applied before the use of the ointment.

Scalp: Applied to the plaques on the scalp together with small amount of cleansing gel after previous wetting of the scalp. Washed off after 2-3 minutes using lukewarm water. Can not be applied to the face.

Body: Applied to the psoriatic plaques, washed off with lukewarm water after 2-3 minutes. Not to be applied to the face.

Formulation: 200 ml in plastic bottles

3.2 Dr. Michaels ointment – head and body

Yellowish-white ointment with characteristic scent.

Components: wheatgerm oil, sweet almond oil, evening primrose oil, pet jelly, zinc oxide, jojoba oil, apricot kernel oil, avocado oil, mineral oil, canrrageenum, carrot oil, fruit acid complex, lavender oil, tea tree oil, bergamot oil, sandalwood oil, patchouli oil, pine oil, geranium oil, orange oil, neroli oil, calendula oil, frankincense oil, citronella oil, chickweed extract, chamomile extract, sesame seed oil, myrrh oil, preservatives.

Effect: Decreases inflammation, infiltration.

Application: Applied to the psoriatic plaques of the scalp and body after using and washing off the cleansing gel. On the scalp only recommended to apply to severely infiltrated plaques.

Formulation: 50 g and 200 g in plastic vials.

3.3 Dr. Michaels skin conditioner -head and body

White colored, viscous substance with characteristic scent.

Components: olive oil, sesame seed oil, mineral oil, beeswax, sunflower oil, emu oil,

lavender oil, eucalyptus oil, rosemary oil, natural vitamin e, chickweed extract, calendula oil, preservatives

Application: Applied to the psoriatic plaques two minutes after using the ointment (without washing it off). The conditioner is applied to the scalp at night and washed off in the morning using the cleansing gel. The conditioner is reapplied at night without washing the head, and washed off again using the cleansing gel in the morning. Formulation: 50 or 200 ml in plastic bottles.

It is recommended to apply the three component product family twice daily, in the morning and at night.

4. PATIENT EVALUATION

4. 1 Inclusion criteria

• mild to moderately sever psoriasis without complications
• both genders, age above 18
• no other current anti-psoriatic therapy
• signed informed consent

4.2 Exclusion criteria

• pustular and erythrodermic psoriasis
• systemic, acetretin, cyclosporin, methotrexate, light therapy currently or within the past 3 months
• topical anti psoriatic therapy
• pregnancy, breast feeding
• known hypersensitivity to any of the components of the products
• lack of informed consent
• low compliance

4.3 Can not be applied to the face, genitals and folds

5. STUDY PROTOCOL

5.1 Time frame

2 weeks of wash out period. During this phase the patients used only emollients. Application time of the Dr. Michaels products:                            6 weeks

Total study length:                                                                                         8 weeks

Evaluation points:                                                        -2, -1, 0, 1, 2, 3, 4, 5, 6 week

Total number of medical evaluations:                                                               8

Patients in the study:                                                                                           30

Application frequency: twice daily

5.2 Evaluation of efficacy

The evaluation was based on the Psoriasis Area and Severity Index (PASI) at each of the 8 medical evaluations.

Evaluated features: erythema, infiltration, parakeratosis, size of affected area.

6. SIDE EFFECTS

6.1 Recording of side effects:

The recording of side effects began on week 3. The characteristics of the side effects, their relation to the product and the additional steps taken were recorded on the datasheet.

6.2 Evaluation of side effects:

Summary evaluation of the side effects was performed after completion of the study.

7. EVALUATION OF THE RESULTS

7.1 Cosmetic effects – tolerability were evaluated at the end of the study based on the statements of the patients.

7.2 Efficacy was evaluated by the physician at the end of the study using the following descriptors: ineffective, moderate effect, good effect, outstanding effect, worsened.

The physician’s evaluation was based on the percent change of the PASI scores.

7.3 The patients stated if they would continue to use of the Dr. Michaels product family.

8. SUMMARY EVALUATION

Upon completion the physician conducting the study provides a summary evaluation.

II. DATA OF THE STUDY

Start date:                                                      2/4/02

End date:                                                       5/22/02

Patients included:                                        30

Patients excluded:                                       3

Patients completed, evaluated:                 27

PATIENT CHARACTERISTICS

Mean age:                                                     47, 26.26 (18-80)

Mean duration of psoriasis:                       17.56 years (2-47)

Gender distribution:                                     male: 18 female: 9

Psoriasis type:                                              plaque type, mild to moderately severe

EVALUATION OF IMPROVEMENT

Worsened                                                      PASI score higher than baseline

Not improved                                                PASI decrease 0-25%

Moderate improvement                               PASI decrease 26-50%

Good improvement                                      PASI decrease 51-75%

Outstanding improvement                          PASI decrease 76-100%

SUMMARIZED CHANGE OF PASI SCORE IN ABSOLUTE VALUES

(Number of patients: 27)

STUDY WEEK

CHANGES OF SKIN SYMPTOMS OF THE STUDIED PATIENTS

Worsened                                                      0 patient

Not improved                                                3 patients

Moderate improvement                               5 patients

Good improvement                                      6 patients

Outstanding improvement                          13 patients

Total                                                               27 patients

The percentage values of the improvement fall between 0 – 98, 68 %

SIDE EFFECTS

Evaluation points of side effects:              1, 2, 3, 4, 5, 6 week

Recorded side effect:                                  folliculitis of lower extremities

pruritus of the scalp, upper torso

Folliculitis occurrence:                             7 total occurrences, 5 males, 2 females Pruritus occurrences:                                     1 total occurrence (female)

COSMETIC EFFECT – EVALUATED BY THE PATIENTS

Good                                                              8 patients

Indifferent                                                      19 patients

SUBJECTIVE EVALUATION OF EFFICACY BY PATIENTS

Ineffective                                                     2 patients

Moderate improvement                               5 patients

Good improvement                                      11 patients

Outstanding improvement                          9 patients

Total                                                               27 patients

PHYSICIAN’S EVALUATION OF EFFICACY

Ineffective                                                     3 patients

Moderate improvement                               5 patients

Good improvement                                      6 patients

Outstanding improvement                          13 patients

Total                                                               27 patients

STATEMENTS OF PATIENTS REGARDING FUTURE USE OF THE PRODUCT FAMILY

Would not continue to use                         2 patients

Would continue to use                               25 patients

SUMMARY

The study was completed in 27 patients out of the originally included 30. Three patients dropped out due to lack of compliance in two cases and due to the retraction of informed consent in one case.

We only studied patients with mild to moderately severe psoriasis.

The product proved to be ineffective in three of the 27 patients (11.21%). 5 patients(18.52%) had moderate improvement, 25-50% of the skin lesions cleared up. 6 patients (22.22%) had good improvement, 51-75% of the lesions disappeared. 13 patients (48.14%) showed outstanding improvement with the regression of 76-98.86% of the lesions.

7 patients developed folliculitis as side effect that was clearly related to the product family. The folliculitis was noted at a few treated plaques and the surrounding are on the lower extremities. In six cases the folliculitis regressed upon discontinuation of the application without further treatment. In one case the folliculitis cleared after topical therapy.

One patient developed pruritus of the scalp and upper torso which regressed without discontinuing the application.

No contact sensitization could be noted, which is probably due to the thorough screening applied during patient selection. No patient was included in the study with known hypersensitivity to any component of the product. Important that the information material should warn of this and other exclusion criteria. Although we did not notice such in this limited study, some of the components of the product may have potential photosensitizing effect.

Patients should be warned about folliculitis as a potential side effect.

Although this product is a cosmetic, due to the previously described circumstances it is recommended that the patients seek the advice of a dermatologist before starting the application. In case of noticing side effects the patients should consult a dermatologist.

The cosmetic effect was evaluated as indifferent by 19 patients, and as good by 8 patients.

The evaluation of the treatment by the patients differs from that by the physician. The only identical group is the ‘moderately improved’ (5-5). There was one more ‘not improved’ case according to the physician’s evaluation compared to the evaluation of the patients (3-2). The patients in 11 the physician in 6 cases considered the improvement ‘good’. The distribution of the ‘outstanding’ evaluations is the other way around. The physician considered the improvement ‘outstanding’ in 13 cases while the patients considered it ‘outstanding’ in 9 cases. The differences can be explained by the fact that the physician’s evaluation was based on a pre-determined scale and calculation of the percent-changes, while the patient evaluation was entirely subjective. The patients considered the improvement ‘good’ when it was only moderate based on the calculated scores. However, many patients would only have given ‘outstanding’ evaluation for complete clearing of the lesions.

25 of the patients stated that they would continue to use the product, including those who had only moderate improvement. They argued that they were less concerned about side effects since the product was a cosmetic not a medication.

Because the product family consists of three different components, it is important the package insert should be clear, easy to understand, making the application easy for everyone.

Based on the results of this study, Dr. Michaels product family can be successfully applied in mild to moderately severe psoriasis when considering the exclusion area.

Budapest, Hungary, June 21^st 2002.

Prof. Dr. Attila Horvath

Professor and chairman, lead investigator

Introduction

Psoriasis is:

• Inflammatory & proliferative disease
• Results in chronic, sharply demarcated plaques with silvery scales
• Can be very severe – can lead to hospitalization
• Can be itchy
• Non-contagious
• A chronic, recurring skin disease affecting 2-4% of the population
• Genetic predisposition and secondary triggers play a role in its etiology
• Can occur in any age group or gender
• Frequently affected areas of the body include scalp, extensor surfaces of the extremities, skin folds and nails
• Cannot be cured – but can go into remission

Since psoriasis cannot be cured, it is important to find treatments that are safe and can be used long term. At present topical corticosteroids at the mainstay of therapy for stable chronic plaque psoriasis. Over the past few years, there have been growing concerns about the side effects of steroid therapy. Patients, the world over, are looking for an alternative therapy which is effective and safe. Herbal remedies are the most common treatment options available, however most of these topicals have not undergone the rigorous testing required by the scientific bodies. Over a twenty year period, Dr.Michaels product family has shown to be both effective and safe, however lacked the independent scientific clinical testing.

Aims of the Studies

The studies of the Dr Michaels topical product family were designed to determine the efficacy of the preparations in the treatment of cases of psoriasis with differing severity and establish whether these natural oil contents (the composition and ratio of the natural oils) were able to decrease the psoriatic parakeratosis, inflammation and infiltration.

Objective

To determine the efficacy, adverse effects andtolerabilityof Dr Michaels topical product family.

Characteristics of the Tested Products

• Dr Michaels Scalp and Body Cleansing Gel

Loose, white-opaque, easily applicable topical preparation

Effect: Decreases parakeratosis

Application: Applied before the use of the ointment.

• Scalp: Wet scalp and apply a small amount of cleansing gel. Massage thoroughly and leave for 2-3 minutes. Wash off with lukewarm water.

(Can be applied to forehead but avoid cheek area).

• Body: Wet body. Apply small amount of cleansing gel to the psoriatic plaques. Leave for 2-3 minutes then rinse off with lukewarm water.
• Active Ingredients: Organic acids, fruit acid complex.
• Package: 200ml plastic bottles.

• Dr Michaels Scalp and BodyOintment.

Yellowish-white ointment with characteristic scent.

Effect: Decreases inflammation and infiltration.

Application: Applied to the psoriatic plaques of the scalp and body after using and washing off the cleansing gel. Only apply to severely infiltrated plaques on the scalp.

Ingredients: Vegetable oils (wheatgerm oil, sweet almond oil)

Essential oils (lavender oil, rosemary oil, citronella oil)

Packaging: 50g and 200g plastic vials

• Dr Michaels Skin Conditioner

Effect: Prevent the loss of flexibility and elasticity in the skin.

Application : Applied to the psoriatic plaques two minutes after using the ointment (without washing it off)

Application to the scalp without ointment : The conditioner is applied to the scalp, left on over night and then washed off in the morning using the cleansing gel.

Ingredients: A mixture of vegetable and essential oils (olive oil, sesame seed oil, emu oil, lavender oil, eucalyptus oil, natural vitamin E).

Packaging: 50ml and 200ml plastic bottles.

• IT IS RECOMMENDED TO APPLY THE THREE-COMPONENT PRODUCT FAMILY TWICE DAILY, MORNING AND NIGHT.

THE TRIALS

The Hungarian and Romanian open trials involved 57 patients (30 males, 27 females), suffering with mild to moderately severe plaque type psoriasis, between the ages of 18 to 80 years old. The mean age was 45.2 years with a mean duration of psoriasis of 15.3 years.

Five patients dropped out due to non-compliance and one due to retraction of informed consent.

The evaluation was based on Psoriasis Area Severity Index (PASI) score at each of the 8 medical evaluations. Evaluated features included erythema, infiltration, parakeratosis and size of affected lesions.

Eight weekly evaluations were done.

The evaluation of improvement was based on the following:

Worsened PASI score higher than baseline

No improvement PASI decreased 0-25%

Moderate improvement PASI decreased 26-50%

Good improvement PASI decreased 51-75%

Outstanding improvement PASI decreased 76-100%

The product family proved to be ineffective in 5 of the 57 patients (9%).

11 patients (19%) had good improvement with 51-75% of skin lesions disappeared.

30 patients (53%) showed outstanding improvement with the regression of 76-100% of the lesions.

23% of the patients developed folliculitis for a short period as s side effect. The folliculitis was noted on a few plaques of the lower extremities and was insignificant in terms if severity. 5% of the patients developed pruritis, which regressed without discontinuing the application.

No contact sensitization was noted, which is probably due to the thorough screening applied during patient selection.

The cosmetic effect was evaluated as indifferent by 49% of the patients, as good by 35% of the patients and as excellent by 16% of the patients.

The evaluation of the treatment differed from that of the physician. The physician considered the improvement outstanding in 53% of the cases, while the patients considered it outstanding in 33% of the cases. The differences can be explained by the fact that the physician’s evaluation was based on a pre-determined scale and calculation of percentage changes, while the patients evaluation was entirely subjective. Many patients would have given outstanding only for complete clearing of the lesions. 95% of the patients stated that they would continue to use the product family including those who had only moderate improvement. They argued that as the product family was a cosmetic not a medication, they were not considered about safety and bad side effects.

Conclusion

Based on the results of these studies, Dr. Michaels new complementary treatment can be successfully applied in mild to moderately severe psoriasis.

In the Russian clinical examination there were 30 patients between the ages of 9 to 60 years with psoriasis of different severity. There were 3 girls, 12 boys while the adults consisted of 5 women and 10 men. The severity of the clinical symptoms were evaluated using PASI scores with

Mild psoriasis PASI less or equal to 20 (12 patients)

Moderately severe PASI bigger than 21 and less or equal to 50 (9 patients)

Severe PASI bigger than 51 (9 patients)

Four evaluations were done at weekly intervals. 10 patients (84%) in the mild psoriasis group went into clinical remission and 2 patients had no improvement. 4 patients (44%) in the moderately severe group went into remission, 2 had significant improvement, one had improvement and 2 had no effect. In the severe group 2 patients (22%) went into remission, 4 patients had significant improvement, 2 had improvement while one had no effect.

In the 30 patients treated, 22 patients (73%) had significant improvement or better. Dr. Michaels product family is highly effective and in terms of efficacy, it is comparable to the generally used therapeutic regimen, which is based on the application of corticosteroids with fluorid content. Dr. Michaels preparations do not have severe side effects and are user-friendly. They do not have an unpleasant smell and do not stain the underwear. They can be successfully applied in the case of outpatients as well. Dr. Michaels preparations have been used successfully on patients with psoriasis exceeding 30% of total body surface area (TBSA), however other parallel applications available CANNOT exceed 30% of TBSA of the patient.

Conclusion

Based on the clinical results Dr. Michaels product family can be used successfully to treat mild to severe forms of plaque and exudative types of psoriasis.

The Austrian trial was a “Randomized Controlled double-blind study” involving 34 patients (15 females, 19 males). Evaluation of improvement was based on PASI scores. 14 patients in the verum group (those treated with Dr. Michaels product family) and 10 patients in the placebo group completed the treatment course, 10 patients did not complete the eight week of trial. Before therapy, the mean PASI score of the verum group was 6,8 +/- 2,4 SD, while the placebo group was 5,5 +/- 2 SD. After the 8 week treatment course, the mean PASI score in the verum group was 1,2 +/- 1,01 SD which is equivalent to a PASI score reduction of 89% +/- 14,9 SD. The respective values for the placebo group were 4,1 +/- 1,7 SD and 22% +/- 28,7 SD.

The decrease in PASI scores in the verum is very significant after 8 weeks

(P < 0,0001).

Three patients in the verum group and 3 patients in the placebo group reported mild and transient side effects (irritative dermatitis, folliculitis), which did not require any special therapy or caused the patients to discontinue treatment. The majority of the patients who dropped out came from the placebo group.

Conclusion

The investigation showed that Dr. Michaels product family is effective and safe for the treatment of stable chronic plaque psoriasis.

The results from the clinical investigation were so outstanding that the investigators believed that Dr. Michaels product family must contain corticosteroids or calcipotriol. To qualify these issues the Austrian Health Ministry ordered chemical tests be performed immediately. Tests were carried out using HPLC, DAD, and UV methods for calcipotriol and 104 variations of corticosteroids. All the results showed that Dr. Michaels product family contains NO corticosteroids or calcipotriol.

Based on 4 independent clinical investigations involving 121 patients, Dr. Michaels product family has proven to be effective in the treatment of mild to severe plaque and exudative types of psoriasis.

This document was compiled from the Clinical Reports produced from each of the Investigating Institutions by

Jutka Sibik-Kov ács

RICA Pharma s.r.o

Tel : +420 602 290 318

e-mail: skj@ricapharma.cz

PROSPECTIVE, RANDOMIZED PLACEBO-CONTROLLED DOUBLE-BLIND STUDY ON THE EFFICACY AND SAFETY OF A SERIES OF HERBAL SKIN-CARE PRODUCTS FOR STABLE CHRONIC PLAQUE PSORIASIS

Harald Maier, Peter Donath, Michael Tirant, Dragana Relic, Shahla Farokhnia, Herbert Hönigsmann, Adrian Tanew

Division of Special and Environmental Dermatology, Department of Dermatology, University of Vienna Medical School

INTRODUCTION

At present, topical cortisone is still the mainstay of therapy for stable chronic plaque psoriasis as long as the affected skin area is not too extensive. However, there is growing concern among patients about possible side effects of steroid therapy. A recent study showed that overall, 42 % patients were unsatisfied with the current management of their skin disease. This is the reason why, like in other medical specialities, patients with psoriasis more and more, turn to complementary treatment options such as magnetic field resonance therapy, traditional Chinese medicine (TCM) and herbal medicine. It is the young, the well-educated, patients with higher income, women and patients with chronic disease who are most open-minded to complementary methods. Actually, a flourishing market for complementary health products has developed. Unfortunately, most providers refuse to have their products tested according to international scientific standards. Advertising is merely based on anecdotal reports and the single opinions of (mostly prominent) persons. At the very best, uncontrolled clinical observations are presented.

STUDY OBJECTIVE

We assessed the efficacy and safety of an Australian series of herbal skin-care products (Dr. Michaels ® skin-care products for psoriasis) for the management of stable chronic plaque psoriasis. The producer claims that the skin disease improves significantly within a 6 to 8 weeks treatment course.

Methods: Inclusion criteria were: male or female patients with light to medium chronic plaque psoriasis. No other antipsoriatic treatment was allowed. Any antipsoriatic therapy had to be discontinued at least 2 weeks previously. We chose a prospective, randomized, double-blind design. As control we used a series of three common fatty skin-care products which contained no active ingredient. The guidelines for the use were identical for both product series. All skin lesions except the scalp were treated. The cleansing gel was distributed generously on the lesions and washed off after three to five minutes with warm water. Afterwards the lesion was covered with the ointment. After the ointment had dried up the patients applied a thin layer of skin conditioner. The procedure was performed twice daily over a period of 8 weeks. Before treatment, after 2, 4, 6 and 8 weeks a blind observer assessed the Psoriasis Area Severity Index (PASI). The values of scalp involvement were not included. Standardized photos of typical lesions were taken before and after 2, 4, 6 and 8 weeks treatment. For statistical analysis we used Mann-Whitney-U Test made with SPSS for Windows.

Results: We assigned 34 (15 f /19 m) patients to our study population. 14 patients of the group which was treated with the herbal products and 10 patients of the control group completed the treatment course. Before therapy the mean PASI score of the group with the herbal products was 6.8±2.4 SD, and 5.5±2 SD in the control group, respectively. After the 8 weeks treatment course the mean PASI score reduction in the herbal group was 1.02±1.01 SD, which is equivalent to a PASI score reduction of 89%±14.9 SD. The respective values in the control group were 4.1±1.7 SD and 22%±28.7 SD. Three patients in the herbal and three patients in the control group reported mild and transient side effects (irritative dermatitis, folliculitis).

DISCUSSION: This study shows that the herbal skin-care products tested improve mild to moderate stable chronic plaque psoriasis significantly. One strength of this study is the clear study design which is regarded as the gold standard of clinical tests. As is well known, the PASI is a standardized internationally accepted evaluation score which in the hands of an experienced clinician is a reliable assessment tool.

It was so obvious in the study course that the verum products were superior to the placebo preparations. Except for coal tar which is present in only the cleansing gel, none of the listed herbal ingredients is a known antipsoriatic remedy.

Therefore, an analysis for undeclared drugs (cortisone, calcipotriol, macrolides) was undertaken although the producer (who is one of the authors, M.T.) gave a statement of innocuousness and provided the complete list of constituents and the respective material safety data sheets. Two samples of different batches of each product were analysed. None of the products contained any of the compounds mentioned above.

CONCLUSIONS: The products tested already fulfil a lot of aspects addressed by the European Parliament in the proposal for a directive on traditional herbal medicinal products. Our investigation demonstrates that complementary methods may play a role in dermatologic therapy as far as they undergo standardised clinical trials and fulfil the basic requirements such as product safety and quality assurance. Dr Michaels skin-care products can be used successfully in the treatment of stable chronic plaque psoriasis.