EUCTR2015-002838-46-IE进行中（未招募）1 期
A prospective, randomised, vehicle-controlled, double-blind, exploratory clinical trial to assess the efficacy and steroid sparing potential of DGLA cream topically applied to early childhood patients with moderate to severe atopic dermatitis.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- DS Biopharma
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
- •1. Female and male infants aged 3-12 months.
- •2. Diagnosis of atopic dermatitis according to the Hanifin and Raika Criteria.
- •3. Patients with moderate to severe atopic dermatitis (IGA =3)
- •4. Patients with atopic dermatitis covering a minimum of 10% of the body surface area at baseline.
- •5. Atopic Dermatitis is stable for the past 7 days, in the opinion of the investigator.
- •6. The patient's parents are able to apply the study product twice a day (each morning and evening) for a consecutive period of 63 days.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any clinically significant controlled or uncontrolled medical condition that would, in the opinion of the investigator, put the patient at undue risk or interfere with interpretation of study results.
- •2. Clinically significant impairment of renal or hepatic function.
- •3. Clinically significant immunodeficiency.
- •4. Use of systemic antibiotics less than 2 weeks prior to Baseline Visit (Day 0).
- •5. Other skin conditions that might interfere with atopic dermatitis diagnosis and/or evaluation (such as psoriasis or current viral, bacterial and fungal skin infections).
- •6. History of intolerance to any ingredient in DS107E DGLA cream or Vehicle or intolerance to any ingredient in Locoid® Ointment (hydrocortisone butyrate 0.1%).
- •7. Use of systemic treatments that could affect atopic dermatitis less than 4 weeks prior to Baseline Visit (Day 0), e.g. oral corticosteroids; Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions are allowed.
- •8. Treatment with any experimental drug within 30 days prior to Day 0 Visit (Baseline), or 5 half-lives (whichever is longer).
- •9. Excessive sun exposure or other ultraviolet (UV) light sources 4 weeks prior to Day 0 Visit (Baseline) and/or is planning a trip to sunny climate or other UV sources between screening and follow-up visits.
- •10. Use of any topical medicated treatment for atopic dermatitis 2 weeks prior to start of treatment/Day 0 Visit (Baseline), including but not limited to emollients, topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials and bleach baths.
- •11. Use of topical products containing ceramides 2 weeks prior to Day 0.
- •12. Medical history of chronic infectious disease (e.g., hepatitis B, hepatitis C or infection with human immunodeficiency virus).
研究者
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