CTRI/2012/12/003176
Completed
N/A
Assessment of the efficacy of a 6-week randomized, controlled half-face treatment with topical formulae containing 4% ER2412 compared to placebo in healthy volunteers with oily skin.
OREAL RESEARCH0 sites37 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- OREAL RESEARCH
- Enrollment
- 37
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\-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
Outcomes
Primary Outcomes
Not specified
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