EUCTR2008-008353-35-FR进行中（未招募）1 期
EFFICACY STUDY OF A CICLOPIROXOLAMINE 1% FOAM (DC115 GM 02A) VERSUS CICLOPIROXOLAMINE 1.5% SHAMPOO (SEBIPROX®) IN THE TREATMENT OF MODERATE SEBORRHEIC DERMATITIS OF THE SCALP
PIERRE FABRE DERMATOLOGIE REPRESENTED BY INSTITUT DE RECHERCHE PIERRE FABRE0 个研究点目标入组 44 人开始时间: 2009年3月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
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
入选标准
- •Patients must meet all the following criteria to enter the study:
- •-Patients aged more than 18 years old,-Stable or exacerbating seborrheic dermatitis of the scalp as evidenced by a score of scaling and erythema between 2 to 4,
- •-Comparable intensity of seborrheic dermatitis on both sides of the half head,
- •-Patients who agree to stop application of any topical product (drugs and/or cosmetics) on the scalp and use only the delivered soft shampoo during the study period,
- •-Written Informed Consent Form obtained from the patient,
- •-Patient willing to attend the planned all visits at the investigational centre and to comply with all trial requirements,
- •-Patient registered with a social security,
- •-For woman of childbearing potential:
- •?negative urine pregnancy test at inclusion,
- •?use an efficient method of contraception (implants, injectables, oral contraceptives, intra-uterine devices, tubal ligature) for at least 2 months before the study, during and one month after the end of 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
- •Patients who have one of the following criteria will not be allowed to enter the study:
- •* Related to the pathologies
- •-Severe seborrheic dermatitis requiring a treatment with corticosteroids,
- •-Psoriasis of any type and anywhere on the body,
- •-Asthma requiring regular treatment with corticosteroids (inhaled, oral or injectable),
- •-History and/or current disease of immunosuppression,
- •-Parkinson disease,
- •-History of a major medical/psychiatric illness or surgery which, in the judgement of the investigator, may interfere with study medication, metabolism and/or study implementation and/or study parameter assessment(s).
- •*Related to treatments
- •-Patients with a history of hypersensitivity to ciclopiroxolamine and/or to at least one ingredient of the products,
- •-Treatment with any other investigational product in the 4 weeks prior to the inclusion visit,
- •-Topical treatment of the scalp with other antifungal medication, retinoids, erythromycin, tetracycline or any of its derivates, trimethoprim/sulfamethoxazole, metronidazole, or corticosteroids within the 2 weeks prior the inclusion visit,
- •-Systemic use of retinoids, erythromycin, tetracycline or any of its derivates, trimethoprim/sulfamethoxazole, or metronidazole within the 4 weeks prior to the inclusion visit,
- •-Systemic use of corticosteroids within the 12 weeks prior to the inclusion visit,
- •* Related to the population
- •-Sensitive skin to topical or cosmetic products,
- •-History of drug or alcohol abuse,
- •-Female who is pregnant or breast feeding or not using contraception, or planning to become pregnant,
- •-Participation to an other clinical trial in the previous month or during the study,
- •-Patient who, is not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent,
- •-Patient who, in the judgement of the investigator, is not likely to be compliant during the study,
- •-Patient who has forfeited his/her freedom by administrative or legal decision, or who is under guardianship.
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