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.

 

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