Multicentric, Randomized, Double Blind Study Under Dermatological Control for Evaluation of the Antidandruff Maintenance Effect of One Shampoo (Reference 1144628 D) Versus Its Vehicle (Reference 1144781) During 8 Weeks After a Ketoconazole-based Antifungal Treatment During 4 Weeks in Adult Subjects (Male and Female) With Light to Moderate Seborrheic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Antisquame efficacy of the tested shampoo versus its vehicle with Visual Analog Scale after 8 weeks
研究概览
简要总结
The aim of this study was to investigate the changes in the scalp bacterial and fungal microbiota in subjects afflicted with a scalp seborrheic dermatitis (SSD) during a 2% ketoconazole-based treatment followed by a maintenance phase (1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo versus its vehicle).
详细描述
Seborrheic dermatitis is a chronic, recurrent, cutaneous inflammatory condition that causes erythema and skin flaking, sometimes appearing as macules or plaques with dry white or moist oily scales. In general, this condition affects patients in good general health.
In adults, it commonly occurs in areas with high concentrations of sebaceous glands. The scalp is the most frequently affected area (80-90 percent of the cases).
These plaques are usually masked by the hair but covered by abundant dandruff, very visible on the head and even on the clothes. In the severe forms, the dandruff plaques develop into "helmets": they then cover tufts of hair and can cause them to fall.
On the scalp, the lesions may range from mild desquamation to brownish crusts affixed to the skin and hair. Some patients report pruritus, particularly if the scalp is affected. Secondary bacterial infection may occur, aggravating erythema and exudate and causing local discomfort.
Dandruff is regarded as a mild non-inflammatory form of seborrheic dermatitis. The cause of seborrheic dermatitis is not well understood, but its occurrence appears to be related to the proliferation of commensal Malassezia species.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind study
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject with hair length > 2 cm.
- •Subject exhibiting a slight to moderate seborrheic dermatitis on the scalp after clinical examination, on D
- •Subject exhibiting slight to severe squame state of scalp: Total squame score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including an adherent squame score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent squame score on D
- •Subject usually using a shampoo 3 times a week and accepting to follow this rate during the whole study period.
- •Subject having stopped any possible antidandruff treatment at least 2 weeks prior to D
- •Subject usually using seborrheic dermatitis treatments
排除标准
- •• Main Inclusion Criteria:
- •Subject with hair length > 2 cm.
- •Subject exhibiting a slight to moderate seborrheic dermatitis on the scalp after clinical examination, on D
- •Subject exhibiting slight to severe squame state of scalp: Total squame score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including an adherent squame score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent squame score on D
- •Subject usually using a shampoo 3 times a week and accepting to follow this rate during the whole study period.
- •Subject having stopped any possible antidandruff treatment at least 2 weeks prior to D
- •Subject usually using seborrheic dermatitis treatments
- •Main Non-Inclusion Criteria:
- •Subject who has skin marks on the scalp that could interfere with the assessment (pigmentation trouble, scar elements...).
- •Subject who used topic treatment for the scalp (anti-dandruff, anti-hair loss, soothing) or corticosteroid treatment (per os or topical) during the last two weeks before the start of the study.
- •Subject with personal history of allergy and/or particular reactivity to antidandruff products.
- •Subject with personal history of allergy and/or adverse reactions to cosmetic products containing tensioactive agents
- •Subject who has taken: corticoids within 2 weeks before the study entrr, or anti-histaminic, anti-fungal, non-steroidal anti-inflammatory, immunosuppressive, or lithium-based drugs less than 1 month before the study entry, or retinoid acid (local or per os) since less than 6 months before study entry.
- •Subject with cutaneous affection of the scalp other than seborrheic dermatitis (psoriasis, alopecia in vertex, pediculosis, atopic dermatitis ...).
- •Subject affected by serious, non-stabilized or progressive disease as diabetes, hypertension, hypothyroidism or hyperthyroidism which may influence the evolution of studied cutaneous state and morphology.
- •Subject affected by serious pathology (cancer, immune-depressed)
- •Subject who has undergone a surgical operation in the previous month of the study or having planned it during the study.
- •Subject who has started, stopped or changed of hormonal treatment (including contraceptive pill) in the previous 6 weeks.
- •Pregnancy or breastfeeding during the last 6 months, ongoing or planned during the study
结局指标
主要结局
Antisquame efficacy of the tested shampoo versus its vehicle with Visual Analog Scale after 8 weeks
时间窗: before and after 8 weeks of treatement
Change at 8 weeks versus Baseline at 8 weeks of the squamous scale of the shampoo versus vehicle
次要结局
- Change in scalp microbiome (quantification)(before and after 8 week treatment period.)
- change in scalp microbiome (qualification)(before and after 8 week treatment period.)