EUCTR2007-004627-38-FI进行中（未招募）不适用
Efficacy and safety of ASF 1057 cream 0.5% in the treatment of seborrhoeic dermatitis: A phase III randomised, double-blind, vehicle- and placebo controlled, parallel groups, multi-centre trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- •Patients will be entered into this trial only if they meet all of the following criteria:
- •1.Patients of either sex at least 18 years of age,
- •2.A clinical diagnosis of seborrhoeic dermatitis defined as inflamed dermatitis with both erythema and scaling, involving at least the medial part of the eyebrows, and/or the glabella, and/or the nasolabial folds,
- •3.Moderate to severe seborrhoeic dermatitis defined as an involvement of at least 4 cm2 skin area with an OSS = 4 score units and a score for erythema = 2 score units:
- •Note: The degree of erythema and scaling at inclusion should be predominating throughout the area to be evaluated. It is not sufficient that there is only a small spot in the area with e.g., an erythema score = 2 score units for the patient to be included.
- •4.Skin type: I to IV,
- •5.Signed and dated informed consent,
- •6.Sexually active females of childbearing potential must be either surgically sterile (hysterectomy or tubal ligation) or use a medically accepted contraceptive method (and agree to use it during the trial) such as:
- •Systemic contraceptive (oral, implant, injection),
- •Diaphragm or cervical cap with intravaginal spermicide,
- •Intrauterine device, or
- •Condom with intravaginal spermicide.
- •In Denmark and Germany, one of these contraceptive regimens must have been used for at least 12 weeks before Visit 2, and the patients must agree to continue their contraception during the trial and for 1 month after the end of the trial.
- •7.Willingness and ability to comply with the trial procedures.
- •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 will not be enrolled if they meet any of the following criteria:
- •1.Female patients who are pregnant or breast-feeding,
- •2.Known allergy to any of the constituents of the product being tested,
- •3.Known immunosuppressive (e.g., AIDS/HIV) or neurological diseases (e.g., Parkinson’s disease or MS),
- •4.Presence of another serious or progressive disease which, according to the Investigator may interfere with treatment outcome,
- •5.Active skin disease such as psoriasis, atopic dermatitis, rosacea, lupus erythematosus, or other inflammatory or infectious skin disease which, according to the Investigator may interfere with treatment outcome,
- •6.Use of topical medical treatment in the face, e.g., anti inflammatory (e.g., corticosteroids, non-steroidal anti inflammatory drugs [NSAIDs] or calcineurine inhibitors), coal tar preparations, anti-seborrhoeic preparations, antihistamine, antibiotics, or antifungal during the 2 weeks preceding the baseline visit (Day 0),
- •7.Use of systemic medical treatment:
- •a.Anti-inflammatory drugs (e.g., calcineurine inhibitors), antihistamines, antibiotics, antifungals during the 2 weeks before the baseline visit (Day 0),
- •b.Corticosteroids and immunosuppressant treatment during the 4 weeks preceding the baseline visit (Day 0),
- •c.Retinoids during the 6 months preceding the baseline visit (Day 0),
- •8.Planned change in hygiene habits and toilet products in the face during the trial,
- •9.Planned extensive sun exposure during trial participation (i.e., sun exposure leading to reddening of the skin),
- •10.Planned use of cosmetic products on the area to be treated such as; moisturizer, cleanser, facemasks, peeling creams and acne-stick or any other stick used to mask pimples during treatment period,
- •11.Participation in another clinical trial during the last month preceding the baseline visit (Day 0).
研究者
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