None listed
Conditions
Interventions
Intervention1: Topical Gel Containing 4% ER2412: Topical Gel containing 4% ER2412 to be applied approximately 2 mg/ square cm once daily on half face for 6 weeks
Control Intervention1: Placebo of sam
Sponsors
LOREAL RESEARCH
Eligibility
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -clinical scoring of skin oiliness (oily touch, shiny aspect and pore size) - Photography scoring (in normal, ultra-violet, cross polarized and parallel polarized light)of skin oiliness and acne lesions -Clinical evaluation and counting of cutaneous inflammatory/non inflammatory acne lesions -Clinical scoring of brightness with Brightness scale -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
| Measure | Time frame |
|---|---|
| -Skin Conductivity with a corneometer® - Perception of skin oliness with an auto-assessment questionnaire -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 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) | — |
Countries
India
Contacts
Public ContactRashi Nangia
CIDP Biotech India Pvt. Ltd
Outcome results
None listed