None listed
Conditions
Interventions
Intervention1: Benzoyl Peroxide: 2.5% gel, once daily topical administration on half-face at a dose of 2 mg/cm2
Intervention2: Benzoyl Peroxide: 5% gel, once daily topical administration on half-fac
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Facial skin appearance: clinical scoring of skin oiliness (oily touch, shiny aspect and pores size, ..)and brightness , counting of acne lesions, sebum rate on forehead& cheeks, photography scoring Timepoint: Days 1, 8, 15, 29, 36 and 43 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Lipidic composition of sebum sampled from Sebumeter® tapes on the forehead on days 1, 29 and 43 â?¢ Skin conductivity with a Corneometer® on days 1, 8, 15, 29, 36 and 43 â?¢ Perception of skin oiliness with an auto-assessment questionnaire on days 1, 8, 15, 29, 36 and 43. Timepoint: Days 1, 8, 15, 29, 36 and 43 | — |
Countries
India
Contacts
Public ContactRashi Nangia
CIDP Biotech India Pvt. Ltd.
Outcome results
None listed