A randomized, open-label, monocentric clinical phase I/IV study in healthy human volunteers to evaluate the skin tolerability and cosmetic acceptance of three marketed anti-acne drugs (Differin® Creme, Erylik® Gel, and Zindaclin® 1 % Gel) - Skin tolerability and cosmetic acceptance of three marketed anti-acne drugs

• Registration Number: EUCTR2004-004606-24-DE
• Lead Sponsor: Fujisawa GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•men and women with healthy but mixed to oily skin
•between 18 and 50 years of age
•willingness to actively participate in the study and to come to the scheduled visits
•panelist is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study
•willingness to use test products once daily on facial skin throughout the course of the study and to refrain from use of other skin care products like creams or lotions for the facial skin two days before the start of the study and during the course of the study
•willingness to continue with the normally used facial cleansing products and decorative cosmetics and to refrain from changing brands throughout the course of the study
•willingness to refrain from decorative cosmetics (e.g. mascara, make-up, cover cream, etc.) in the morning before the initial visit as well as before the final visit
•signed written confirmation to use safe contraception (in female panelists of child bearing potential)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•moles, tattoos, pigmentation or scars on the face that would influence the dermatological assessments
•panelist has any medical condition or disorder that precludes him/her from participating in the study in the opinion of the investigator
•panelist has a known allergy to components of the study drugs or to other cosmetic products
•use of sunbeds or UV-treatment or intense sun exposure during the study period or within two weeks before baseline
•any systemic treatment or the intake of drugs interfering with the immune system (e.g. antiphlogistics, corticosteroids, immunosuppressants, and antihistamines) within 28 days before start of the study. This does not include minor pain relief medicine, like aspirin or acidamidophene if not more than 500 mg per day are used.
•topical therapy of the face in the last two weeks, e.g. corticosteroids
•pregnancy or lactation
•any history of drug addiction or alcoholism in the past 3 years
•infectious diseases (e.g. hepatitis or AIDS)
•panelists with expected poor compliance
•participation in a clinical trial within the last 30 days prior to the start of this study
•panelists underlying any other restrictions due to the participation in other studies / test institutes
•employees of the study sites or of the Sponsor company
•if in the opinion of the investigator the panelist should not participate in the study for any reason

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified