Assessment of the efficacy of a 6-weeks randomized, controlled half-facetreatment with topical formulae containing P798208 08 compared to itsplacebo in healthy volunteers with oily skin.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- efficacy of a compound on oily skin as determined by clinical and instrumental
研究概览
简要总结
The study will be monocentric, comparative, placebo controlled, double-blinded and randomized half-face application out patient study. The study objectives are (1) To assess the efficacy of a compound on oily skin as determined by clinical and instrumental evaluations measuring the amount of sebum and its effect on acne formation and (2) to assess the safety and local tolerance of a formulae containing P798208 08 in facial cosmetic products. The study rationale is to evaluate the effect of a mix of essential oils (P798208 08) containing mostly lemongrass and rosemary essential oils. This active mix is expected to reduce p.acnes, inflammation and stimulate the exfoliation process that will reduce sebum secretion and acne formation. Topical application (on the face) will be done once a day on dried skin from study days D1 to D42. The subjects will receive a topical gel containing P798208 08 on one half face, and corresponding vehicle on the other half of the face according to a pre-determined randomization list. The subject study period is 6 weeks and study duration is 8 weeks. The study will be conducted in healthy human male volunteers (age 18-40 yrs) with oily skin. Thirty seven subjects will be enrolled to ensure that at least thirty two randomized subjects complete the study procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Male
入选标准
- •· Healthy male volunteers, aged 18 – 40 years · Skin phototype II-V (Fitzpatrick) · Presenting an oily skin appearance on the face (sebum rate 70 μg/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.
排除标准
- •· 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, antiinflammatory drugs…) 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, …), · Subject reported or planning to sun-bath or to overexpose to UV-light (mountains sports, phototherapy, tanning salon use…) 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.
结局指标
主要结局
efficacy of a compound on oily skin as determined by clinical and instrumental
时间窗: Day 1, 8, 15, 29, 36 and 43
evaluations measuring the amount of sebum and its effect on acne formation.
时间窗: Day 1, 8, 15, 29, 36 and 43
次要结局
- safety and local tolerance of a formulae containing P798208 08 in facial cosmetic products.(Days 1-43)