NCT00863005已完成1 期
Assessment of the Effects on Barrier Impairment, Clinical Features and Bacterial Colonization of Topical Formulations in Patients With Atopic Eczema; a Phase IIa, Single-center, Randomized, Observer-blind Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Transepidermal water loss (TEWL), clinical assessments, corneometry, bacterial counts
研究概览
简要总结
The purpose of the study is the assessment of the barrier impairment, clinical skin condition and bacterial colonization status in patients with atopic eczema following topical treatment with K201 cream and a comparator twice daily over a 4-week treatment period.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed written informed consent obtained;
- •male or female patients, 18 years or older;
- •manifest atopic eczema diagnosed according to Hanifin and Rajka;
- •two comparable lesional areas of 20 - 50 cm2 with a distance of at least 5 cm, clinical condition of atopic eczema mild to moderate (meeting Hanifin and Rajka´s criteria;
- •TEWL in the lesional areas at least 12 g/m²h, TEWL value differences ≤ 30 % are allowed between both lesional areas;
- •the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
- •sexually active females of childbearing potential should either be surgically sterile hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen:systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide.
排除标准
- •acne, eczema other than atopic eczema, hyper- or hypopigmentation or tattoos in the treatment areas;
- •suntan which in the opinion of the investigator prevents correct assessments
- •dark-skinned persons whose skin color prevents ready assessment of skin reactions;
- •evidence of drug or alcohol abuse;
- •pregnancy or nursing;
- •UV-therapy within 6 weeks before first treatment;
- •participation in another clinical study involving pharmaceutical products in the 28 days preceding or during the study;
- •symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
- •known allergic reactions to components of the study preparation and the comparator;
- •treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. antihistamines or glucocorticosteroids) within two weeks before the beginning of the study (exception: asthma may be found in patients with atopic eczema,therefore inhalation with corticosteroids in patients with asthma accompanying atopic eczema will be allowed at a dose not exceeding 1 mg/day. The dosage should remain constant throughout the study period);
- •in the opinion of the investigator or physician performing the initial examination the patient should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent;
- •patient is institutionalized because of legal or regulatory order.
研究组 & 干预措施
1. K201
Experimental
干预措施: K201 (Drug)
2.
Active Comparator
干预措施: K201 (Drug)
结局指标
主要结局
Transepidermal water loss (TEWL), clinical assessments, corneometry, bacterial counts
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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Assessment of the effects on barrier impairment, clinical features and bacterial colonization of topical formulations in patients with atopic eczema; a phase IIa, single-center, randomized, observer-blind study - Atopic eczemaTo assess the barrier impairment, clinical skin condition and bacterial colonization in patients with atopic eczemaMedDRA version: 9.1Level: LLTClassification code 10003641Term: Atopic eczemaEUCTR2008-005890-37-DEMoberg Derma AB30
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