Phytoskin®, a new cream for psoriasis and atopic dermatitis containing plant extracts

Townsend Letter for Doctors and Patients, Dec, 2005

Key Words: Phytoskin[R] Cream, psoriasis, atopic dermatitis, juglans regia (walnut), symphytum officinale (comfrey)

Abstract

A new cream containing low molecular extracts from juglans regia and symphytum officinale was evaluated in 43 patients with psoriasis or atopic dermatitis in an observational study. The majority of the patients judged the properties like content of fat, effect on skin moisture, grooming properties and tolerability as well as the effects on symptoms of their disease like scaling, reddening, itching and burning, as excellent. They observed a reduction in the severity of their disease in 70% (95%-confidence interval 58%-83%) and a remission of acute flares in psoriasis in 61% of the cases. The improvement in severity of disease with 83% in psoriasis was significantly higher than in atopic dermatitis (55%). The hypothesis on the efficacy of Phytoskin[R] will be tested in an appropriate study.

Rationale

Phytoskin[R] cream (development code TS 9912) was developed by Thymuskin Cosmetic GmbH, Germany, as an agent for skin grooming in psoriasis and atopic dermatitis. It is well known that proteins are not able to penetrate into the skin to a notable extent. Small peptides, though, reach lower skin regions to a higher extent, be it through existing channels of dermal organelles (glands and hair follicles) or via micro-fissures of affected skin. To enhance the grooming and curative actions of plants well known in herbal medicine by cleavage of their proteins into peptides was the rationale for this development. The walnut (juglans regia) as one herb was selected because its extracts were successfully applied topically in these diseases by an osteopath, and comfrey (symphytum officinale) as the second, because of its favourable effects well known in herbal medicine and applied over a long time.

Composition

Phytoskin[R] cream contains the low molecular extracts from walnut and comfrey root in 2 vol.%, and 0.8 vol.% respectively, in a lipophilic cream for application to psoriatic lesions as Phytoskin[R] lipophil and in a hydrophilic cream as Phytoskin[R] hydrophil for use in neurodermatitis or atopic dermatitis, respectively. In the observational study to be reported here only the lipophilic cream was used. The hydrophilic formulation was developed after the analysis of this study as a result of the evaluation of its grooming properties by the patients. This new formulation will be submitted to a re-evaluation.

Data Collection on the Application of TS 9912

Initially several patients with psoriasis and atopic dermatitis were treated tentatively with Phytoskin[R] cream. The results of this free application were to be documented retrospectively in a questionnaire, which was developed with support by the Dermatology Clinic, Darmstadt, Germany, which was done in 4 patients. On this questionnaire also were the results of further 39 patients, who were treated prospectively at two trial-centres (Dr. med. W. Stein, Mannheim, and J. G. Schilling, Maintal-Hochstadt, Germany), and documented. The questionnaire comprised data with regard to demography, medical history, presence and therapy of the underlying disease, psoriasis or atopic dermatitis, and of concomitant illness. The grooming properties of the test preparation and its influence on important symptoms of the disease had to be evaluated. Comparisons in the presence of acute flares and the degree of severity at the commencement of application of the test preparation and at its termination had to be made. Finally, adverse reactions and reasons for a premature termination had to be documented. The biometric evaluation was performed by the Institute of Medical Informatics, Biometry and Epidemiology of the Medical School in Essen, Germany.

Demography

In a total of 43 patients with psoriasis or atopic dermatitis the cosmetic properties and effects of Phytoskin[R] were documented and evaluated biometrically. The diagnosis was psoriasis in 23 and atopic dermatitis in 20 patients. The female gender prevailed slightly with 57% in the study population. The mean age of the patients with psoriasis was 56 years and 40 years in the atopic dermatitis group. According to the difference in age the number of concomitant diseases was higher in the psoriasis patients. Otherwise the groups were comparable. Of the patients with atopic dermatitis 1 patient each suffered from allergic asthma and allergic rhinitis, respectively, which led to a therapy with corticoids in one case. The further concomitant diseases and therapies should not have an effect on the skin diseases from a medical point of view. The duration of therapy ranged from 28 to 200 days, was exactly 28 days in 12 patients and ranged from 29 to 100 days in 19 patients. The prevailing majority of patients applied the cream regularly to the affected areas of the body, besides the extremities in both groups, the body in the psoriatic patients and the head in the patients with atopic dermatitis prevailed.

Results

Pre-Medication: The previous medication including topicals, which are medicines but not cosmetics, were documented. Ten patients used a pre-medication consisting of externals containing vitamin B6 or corticoids or those which served only for skin grooming. Nine of these did not apply their previous medication at the end of the treatment period with the trial preparation, which apparently points to their satisfaction with the Phytoskin[R] cream.