EUCTR2012-003954-95-DE进行中（未招募）不适用
Prospective, randomized, double-blind, placebo-controlled, clinical trial to explore the anti-pruritic effect, the safety and local tolerability of a topical Sertaconazol cream 2% in patients with atopic 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）
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
- •- SCORAD (Severity SCORing of Atopic Dermatitis) =40 at inclusion
- •- Male or female (nonpregnant, nonlactating, using contra-ception)
- •- = 18 years or = 75.
- •- Atopic lesions: Arms. Additional: Legs, Neck (areas to be evaluated: arms)
- •- Chronic pruritus, persisting for at least 6 weeks before study start
- •- At the 2 days before Visit 1 Pruritus = 7 (VAS 0-10)
- •- At Visit 1 pruritus intensitiy = 3 (PGA questionnaire of the 5-point Likert Scale)
- •- Signed informed consent after patient information
- •- Agreement to discontinue for the duration of the trial the use of all current moisturizers and to replace them by a standard bland moisturizer given for all patients: Excipial Hy-drocrème
- •- Willing and able to participate in the trial as an outpatient and to comply with all trial requirements
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •-SCORAD at inclusion >40
- •-Evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g. cardiovascular, immunosuppressive, hematologic, hepatic, neurologic, renal, en-docrine, collagen-vascular, urogenital, gastro-intestinal abnormalities or diseases)
- •-Evidence of an active systemic or dermatological infection
- •-Evidence of immunosuppression or cancer
- •-Alcohol- or drug abuse as assessed by the investigator
- •-Participation in an other clinical study within a month of trial entry
- •-Dermatological abnormalities, diseases or conditions in the treatment or surrounding areas that might be exacerbated by treatment with 2% Sertaconazol Cream or impair trial assessments as assessed by the investigator
- •-Allergy or hypersensibility to any of the trial creams ingredients
- •-Treatments before and during the trial:
- •oTopical or systemic anti-histaminic drugs within 2 weeks before trial start
- •oSystemic corticosteroids or high-dosed topical corticosteroids within 4 weeks before trial entry.
- •olmmunomodulatory or cytotoxic treatments within 4 weeks before trial start.
- •oNaltrexon, antidepressants (like Paroxetin, Gabapentin, Pregabalin- if admitted because of their antipruritic effect) within 4 weeks before trial start.
- •oCiclosporin A and other Immunosuppressive drugs within 8 weeks before trial start,
- •oTopical calcineurin inhibitors, topical antibiotics, antiseptic baths and washes within 8 weeks before trial start.
- •-For female patients: pregnancy and lactation
研究者
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