NCT03832647已完成4 期
Multicentric, Parallel, Randomized, Double Blind Study Under Dermatological Control to Evaluate the Anti-acne Efficacy of a Dermo-cosmetic Product (Fla 688977 33) Associated With the Fixed Combination Adapalene 0.1%/ Benzoyl Peroxide 2.5% Treatment Versus This Treatment Associated With a Standard Moisturizer (Hydréane légère, Cosmétique Active International) During a 12-week Application Period in Male and Female Subjects Presenting With Mild to Moderate Acne
Vichy Laboratoires1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年2月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Evaluation of the anti-acne efficacy 1 (number of the retentional and inflammatory lesions)
研究概览
简要总结
Study to evaluate the anti-acne efficacy of a dermo-cosmetic associated with the fixed combination Adapalene 0.1%/ benzoyl peroxide 2.5% treatment and to demonstrate that the dermo-cosmetic product can improve the local tolerance of the fixed combination Adapalene 0.1%/ benzoyl peroxide 2.5% treatment
Multi centre, Randomised, Double blind, Controlled, Parallel (100 subjects per arm), Intra-subject & inter subject comparisons
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double blind
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and/or female subjects aged 16 to 35 years
- •Subjects presenting with mild to moderate acne (stage 2 or stage 3 with at least 12 inflammatory lesions on face according to the Global Acne Evaluation)
- •Female subjects of child-bearing potential who:
- •use the same reliable hormonal contraceptive method (oral contraceptive, implant, intra-uterine device, patch, cervical cap, vaginal ring and injection) for at least 3 months prior to study inclusion and throughout the study or
- •use a reliable non-hormonal contraceptive method (copper intra-uterine device, condoms, diaphragm, cervical cap and spermicide) for at least 1 month prior to study inclusion and throughout the study or
- •have no sexual intercourse and agreeing not to have any throughout the study or
- •are surgically sterile (oophorectomy, hysterectomy or tubal ligation),
- •Subjects and/or all legal representatives (for minor subjects) who have given written informed consent
- •Subjects who are willing to comply with the study requirements
- •Subjects with Social Security (health insurance) coverage (according to the French requirements)
排除标准
- •Subjects with any systemic disorder or face dermatoses other than acne that would in any way confound interpretation of the study results (e.g. atopic dermatitis, eczema, or psoriasis)
- •Subjects with a condition or receiving a medication and/or with a history of medical/surgical events which, in the opinion of the Investigator, could compromise the safety of the subject or affect the outcome of the study
- •Subjects with a history of skin cancer
- •Female subjects who are pregnant (positive urine pregnancy test) or lactating or who are planning to become pregnant during the study
- •Subjects who have started, stopped or changed of hormonal treatment (contraception, thyroid ...) in the 3 months prior the study inclusion
- •Subjects with hypersensitivity to the active substances of Epiduo (Adapalene and/or benzoyl peroxide) or to one of its excipients
- •Subjects who are sensitive to peroxides (oxygenated water)
- •Subjects who have received isotretinoin treatment in the 6 months prior to study inclusion
- •Subjects who have been exposed to excessive UV light (natural or artificial) in the 1 month prior to the study inclusion or having planned excessive UV light exposure during the study (e.g. ski holidays, holidays in the tropics...)
- •Subjects who have used systemic drugs for more than 3 consecutive days related to antibiotics, anti-inflammatory, corticoids, anti-acneic in the 4 weeks prior to study inclusion
- •Subjects who have used topical drugs for more than 3 consecutive days related to antibiotics, anti-inflammatory, corticoids, anti-acneic in the 2 weeks prior to study inclusion
- •Subjects who have used scrub, anti-seborrheic topical cosmetic products and/or who have applied self-tanning products on face in the 1 week prior the study inclusion
- •Subjects who have applied cosmetic products for more than 5 consecutive days with alpha hydroxyl-acids, vitamin C, hyaluronic acids in the 1 week prior the study inclusion
- •Subjects having washed the face and/or the hair the day of the study inclusion (only water is accepted the morning of the study inclusion)
- •Subjects having applied any topical products on face (including make-up) the day of the study inclusion
- •Subjects who have planned a major surgery during the study requiring hospitalization under general anesthesia and the use of systemic or topical drugs (e.g. antibiotics, anti-inflammatory) for more than 1 week
- •Subjects who declare to be deprived of their freedom by administrative or legal decision or who are under guardianship
- •Subjects who cannot be contacted by telephone in case of emergency
- •Subjects belonging to the staff of the study centre
- •Subjects in an exclusion period or participating in another biomedical research study
研究组 & 干预措施
Salicylic acid & Epiduo 0.1%-2.5% Topical Gel
Experimental
Salicylic acid: Once-a-day, on the morning, during 12 weeks.
Epiduo gel: Once-a-day, on the evening (before bedtime) during 12 weeks.
干预措施: Epiduo (Combination Product)
Salicylic acid & Epiduo 0.1%-2.5% Topical Gel
Experimental
Salicylic acid: Once-a-day, on the morning, during 12 weeks.
Epiduo gel: Once-a-day, on the evening (before bedtime) during 12 weeks.
干预措施: Salicylic Acid (Drug)
Hydréane légère & Epiduo 0.1%-2.5% Topical Gel
Placebo Comparator
Hydréane légère: Once-a-day, on the morning, during 12 weeks.
Epiduo gel: Once-a-day, on the evening (before bedtime) during 12 weeks.
干预措施: Epiduo (Combination Product)
Hydréane légère & Epiduo 0.1%-2.5% Topical Gel
Placebo Comparator
Hydréane légère: Once-a-day, on the morning, during 12 weeks.
Epiduo gel: Once-a-day, on the evening (before bedtime) during 12 weeks.
干预措施: Hydréane légère (Other)
结局指标
主要结局
Evaluation of the anti-acne efficacy 1 (number of the retentional and inflammatory lesions)
时间窗: Week 0 (baseline) and Week 12 (final time point)
Change in the number of the retentional (open \& closed comedones) and inflammatory lesions (papulae, pustulae \& nodules (if applicable)) on face after a 12-week application period At Week 0 (before any application) and Week 12 (after a 12-week application period), a counting of the retentional (open \& closed comedones) and inflammatory lesions (papulae, pustulae \& nodules (if applicable)) will be performed by a Dermatologist. The counting will be broken down on several parts of the face (forehead, left and right cheeks and chin).
次要结局
- Evaluation of the anti-acne efficacy 2 (number of the retentional and inflammatory lesions)(Week 4 and Week 8 (intermediary times point))
- Change in the pores visibility after 4, 8 and 12-week application period(Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point))
- Change in skin greasiness after 4, 8 and 12-week application period(Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point))
- Change in the residual marks visibility after 4, 8 and 12-week application period(Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point))
- Change in skin ph after 4, 8 and 12-week application period(Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point))
- Analysis of the efficacy on the skin quality using a questionnaire(Week 12 (final time point))
- Change in skin moisturizing after 4, 8 and 12-week application period(Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point))
- Diameter of the infundibulum in µm after a 12-week application period(Week 0 (baseline) and Week 12 (final time point))
- Change in the acne stage on face according to the Global Acne Evaluation scale after 4, 8 and 12-week application period(Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point))
- Change in the skin shininess after 4, 8 and 12-week application period(Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point))
- Signs of inflammation (number and percentage) after a 12-week application period(Week 0 (baseline) and Week 12 (final time point))
- Vascularization (number and percentage) after a 12-week application period(Week 0 (baseline) and Week 12 (final time point))
- Analysis of the number of subject with adverse event related to the study product(From Week 0 (baseline) to Week 12 (final time point))
- Total number of hair follicles per cube at a mean depth of 38 µm after a 12-week application period(Week 0 (baseline) and Week 12 (final time point))
- Presence of Demodex mites (number and percentage) after a 12-week application period(Week 0 (baseline) and Week 12 (final time point))
- Analysis of the local tolerance using clinical assessments(Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point))
- Products overall tolerance appreciation by the Dermatologist and the subject(Week 12 (final time point))
- Presence of amorphous material into the infundibulum (number and percentage) after a 12-week application period(Week 0 (baseline) and Week 12 (final time point))
- Analysis of the cosmetic acceptability using a questionnaire(Week 12 (final time point))
- Aspect of the border (thickness) (number and percentage) after a 12-week application period(Week 0 (baseline) and Week 12 (final time point))
- Onion like appearence (number and percentage) after a 12-week application period(Week 0 (baseline) and Week 12 (final time point))
- Evaluation of the skin microbiota using sampling (if applicable)(Week 0 (baseline) and Week 12 (final time point))
研究者
研究点 (1)
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