JEADV – Volume 18. Number 6. November 2004. P061

Prospective, randomized controlled double-blind study on the efficacy and safety of a series of herbal skin-care products for stable chronic plaque psoriasis.

H. Maier¹, P. Donath¹, D. Relijc¹, M. Tirant², S. Faroukhnia¹, H. Hönigsmann¹, A. I. Tanew.

¹Dermatology, Medical University of Vienna, Vienna, Austria,

²Dermatology, Psoriasis & Skin Clinic, Melbourne, Australia.

 Background: Among patients with psoriasis concern is growing about possible side effects of long-term steroid therapy and more and more of them turn to complementary treatment options.

Objectives: 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 (cleansing gel, aromatherapeutic ointment, skin conditioner).

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).

Conclusion: Our investigation showed that Dr Michaels ® skin-care products are effective and safe for the treatment of stable chronic plaque psoriasis.