CTRI/2011/10/002080
Completed
N/A
Assessment of the efficacy of a 6-weeks randomized, controlled half-face treatment with topical 2.5 and 5% benzoyl peroxide compared to its placebo in healthy volunteers with oily skin.
OREAL RESEARCH0 sites80 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- OREAL RESEARCH
- Enrollment
- 80
- 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 micrograms/cm2
- •30 mn after degreasing on the forehead right and left)
- •Acne prone subjects showing the presence of facial acne (grade 2\-7 in the Leeds acne grade ), 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
- •Females subjects,
- •Known hypersensitivity to any of the study drugs or constituents,
- •Any significant skin pathology in the test areas, like rosacea, severe acne, or eczema. Subjects with mild to moderate acne will be acceptable provided the condition does not interfere with the objectives of 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, retinoids, anti\-inflammatory drugsâ?¦) within the last 4 weeks prior to participation in the study, and during the study,
- •Any surgical treatment on the test areas (laser peel, dermabrasion, â?¦),
- •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,
- •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.
Outcomes
Primary Outcomes
Not specified
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