Study of effectiveness of a gel (4% ER2412) compared to placebo in healthy volunteers with oily skin.
- Registration Number
- CTRI/2012/12/003176
- Lead Sponsor
- OREAL RESEARCH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 37
Healthy male volunteers, aged 18 â?? 40 years
-Skin phototype II -V (Fitzpatrick)
-Presenting an oily skin appearance on the face (sebum rate >70 µg/cm2 30 min after degreasing on the forehead right and left)
-Acne prone subjects showing the presence of facial acne (grade 2-7 in the attached Leeds acne grade - Appendix 1), presenting at least 15 inflammatory lesions and at least 25 non-inflammatory lesions on the face
-Able to give written informed consent and to comply with the requirements of the study
-Female subjects
-Known hypersensitivity to any of the study drugs or constituents
-Skin disorders affecting the study area which, in the supervisorâ??s / designatorâ??s judgment, would interfere with grading / assessment of skin response (e.g. severe acne grade 8-9 in the Leeds Acne Grade, rosacea, eczema, seborrhoeic dermatitis, psoriasis, disorders of pigmentation, etc â?¦)
-Use of systemic retinoids within the 6 months prior to participation in the study, and during the study
-Any topical or systemic treatment that could interfere with the study treatments/assessments (topical benzoyl peroxide and other antiacne or antiseborreic products, antibiotics, corticosteroids, anti-inflammatory drugsâ?¦) within the last 4 weeks prior to participation in the study, and during the study
-Undergone a facial resurfacing procedure, i.e., chemical peel, laser resurfacing, dermabrasion, within the 6 months prior to participation in the study, and during the study
-Any surgical treatment on the test areas
-Subject reported or planning to sun-bath or to overexpose to UV-light (mountains sports, phototherapy, tanning salon useâ?¦) for aesthetic or therapeutic reason the month before the study start or during the study
-Current use of immunosuppressive drugs and/or an organ transplant
-Insulin-dependent diabetes
-Currently receiving allergy injections, final injection within the last week, or expecting to begin injections during the course of the study
-Immune deficiency or autoimmune disease
-Subjects with clinically significant dermographism or generalized skin disorders that could compromise evaluation of skin reactions
-Vaccination during the three weeks preceding the study or intention to be vaccinated during the course of the study
-A condition or medication which, in the investigatorâ??s judgment, makes the subject ineligible or places the subject at undue risk
-Febrile disease in the three days preceding the study
-Any significant medical condition that would interfere in the participation in the trial
-Participation in a clinical trial up to 1 month prior to inclusion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -clinical scoring of skin oiliness (oily touch, shiny aspect and pore size) <br/ ><br>- Photography scoring (in normal, ultra-violet, cross polarized and parallel polarized light)of skin oiliness and acne lesions <br/ ><br>-Clinical evaluation and counting of cutaneous inflammatory/non inflammatory acne lesions <br/ ><br>-Clinical scoring of brightness with Brightness scale <br/ ><br>-Sebum rate on forehead and cheeks: with a Sebumeter®Timepoint: Visit 1 (Day 1), Visit 2 (day 8), Visit 3 (day 15), Visit 4 (day 22), Visit 5 (day 29), Visit 6 (day 36)and Visit 7 (day 43)
- Secondary Outcome Measures
Name Time Method -Skin Conductivity with a corneometer® <br/ ><br>- Perception of skin oliness with an auto-assessment questionnaire <br/ ><br>-Assessment of incidence of adverse events of treated skin areas for signs and symptoms of skin irritation or sensitization at the end of the study <br/ ><br>Timepoint: Visit 1 (Day 1), Visit 2 (day 8), Visit 3 (day 15), Visit 4 (day 22), Visit 5 (day 29), Visit 6 (day 36)and Visit 7 (day 43)