None listed
Conditions
Interventions
Trade Name: Differin Creme
Product Name: Differin Creme
Pharmaceutical Form: Cream
INN or Proposed INN: Adapalene
CAS Number: 106685-40-9
Concentration unit: mg/g milligram(s)/gram
Concentration type:
Sponsors
Fujisawa GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is the evaluation of skin tolerability and cosmetic acceptance of three marketed anti-acne drugs in panelists (healthy volunteers) with healthy but mixed to oily skin. The aim is to find out the best tolerated and accepted formulation for a new anti-acne drug.;Secondary Objective: ;Primary end point(s): Assessment of Tolerability Dermatological assessment of tolerability for subjective (itching, burning, tension, tickling, feeling of dryness, other) and objective (erythema, dryness, scaling, fissures, papules, pustules, edema, vesicles, weeping, other) dermatological parameters. This assessment will be performed before the first application of each product on study days 1, 8 and 15 and after the last application of each product on study days 5, 12 and 19 (end of study). Additionally the panelists will evaluate the overall skin tolerability of the test products on study days 5, 12 and 19. Assessment of Cosmetic Acceptance Before the first product application on study day 1 the panelists will be asked about the importance of product traits in general. Furthermore the texture, fragrance, application, spreading, stickiness, oiliness, greasiness, penetration, and the overall acceptance of the test products will be evaluated by the panelists immediately after each first application of the substances (days 1, 8, and 15). | — |
Countries
Germany
Outcome results
None listed