EUCTR2008-005217-22-BE进行中（未招募）不适用
Efficacy and Safety of Clobetasol propionate shampoo 0.05% used in association with an antifungal shampoo in the treatment of moderate to severe Scalp Seborrheic Dermatitis - ESCAPE - Scalp Seborrheic Dermatitis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female subjects aged 18 years or older,
- •Subjects with moderate to severe scalp SD defined as:
- •- a score = 3 on the Investigator’s Global Assessment scale
- •- presence of Erythema, Scaling and Pruritus, each of at least moderate
- •severity (severity score = 2),
- •- at least 30% of the scalp area involved (Extend index =2)
- •Female subjects of childbearing potential with a negative urine pregnancy test at the Baseline visit and must practice a highly effective method of contraception during the study: oral/systemic [injectable, patch…] contraception, intrauterine device, strict abstinence, condoms, diaphragms, sponge, spermicides or partner had a vasectomy,
- •Females of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral tubal ligation, or bilateral ovariectomy, secondary infertility and sterility are not required to have a UPT at the beginning of the study,
- •Subjects willing and capable of cooperating to the extend and degree required by the protocol,
- •Subjects have to read and sign the approved Informed Consent Form prior to any participation in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects with a known positive HIV or Hepatitis B/C test result,
- •Subjects suffering from psoriasis,
- •Subjects with a medical status requiring medication that might affect the course of the studied pathology (e.g. skin disease requiring a systemic corticosteroid or antifungal treatment) or interfere with study treatment,
- •Subjects with a known allergy to one of the components of the test products,
- •Subjects with an history of adverse response to topical or systemic steroid therapy,
- •Female subjects who are pregnant, nursing or planning a pregnancy during the study,
- •Subjects with a washout period for topical treatment(s) of their scalp SD less than:
- •Corticosteroids2 weeks
- •All other anti-scalp SD medications (including, but not restricted to: anti-fungals (ketoconazole, ciclopirox olamine…), anti-dandruff products (tar, piroctonolamin, zinc pyritione, salicylic acid, selenium sulphur, keluamid, …)2 weeks
- •Subjects with a washout period for systemic treatment(s) less than:
- •Corticosteroids, anti-fungals - 4 Weeks
- •Immunosuppressive agents, PUVA/UVB therapy - 4 weeks
- •Retinoids and Depot corticosteroids12 weeks
- •Subjects with a condition or who is in a situation which, in the investigator’s opinion, may confound the study results, or may interfere significantly with the subject’s participation in the study,
- •Adult subjects under guardianship, hospitalised subjects in a public or private institution for a reason other than the research, and subjects deprived of freedom,
- •Subjects who have participated in another investigational drug or device research study within 30 days of enrolment.
研究者
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