EUCTR2006-000336-28-DK进行中（未招募）1 期
A 52-week open-label, single-arm, multi-center study to evaluate the long term safety of pimecrolimus 1% cream intermittent treatment of seborrhoeic dermatitis in patients 12 years of age and older
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
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
- •Male or female patients aged 12 years or older
- •Patients with mild, moderate or severe seborrhoeic dermatitis with facial involvement (facial IGA 1-3)
- •Patients who have had at least 3 exacerbations of seborrhoeic dermatitis requiring a medication on the face during the last 12 months
- •Written informed consent (by a legal guardian for patients below the age of consent)
- •Are the trial subjects under 18? yes
- •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
- •Concurrent diseases/conditions and history of other diseases/conditions
- •Presence of any concurrent dermatological condition in the affected area that according to the investigator may interfere with the clinical evaluation (such as: acne, rosacea, pityriasis versicolor, psoriasis, active skin infection).
- •Known HIV infection or history of immunocompromised status (e.g. lymphoma, AIDS, Wiskott-Aldrich syndrome) or known immunosuppression.
- •History or presence of malignancy of any organ system or lymphoproliferative diseases.
- •Other medications / therapies
- •Application of topical corticosteroids or other topical medication (including non-prescription products, except for medicated shampoos) known to influence seborrhoeic dermatitis (such as: antifungals, lithium succinate/gluconate, calcipotriol, tacrolimus, pimecrolimus) within 7 days prior to the first application of study medication.
- •Administration of any systemic immunosuppressor (such as: systemic corticosteroids, systemic tacrolimus, cyclosporine) or phototherapy (e.g. UVB, PUVA) or any other systemic medication (including non-prescription products) known or suspected to have a positive or negative effect on seborrhoeic dermatitis (such as: oral antifungals, lithium salts) within 30 days prior to drug application.
- •Investigational drug / therapy use
- •Use of any investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- •Ingredient hypersensitivity
- •Known serious adverse reactions or hypersensitivity to calcineurin inhibitors, or any ingredients of pimecrolimus cream.
- •Compliance / reliability / investigator’s judgment
- •Patients who are - in the opinion of the investigator - known to be unreliable, or non-compliant, or with any condition or prior or present treatment (including cosmetic products) rendering the patient ineligible for the study.
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)
- •Women of child-bearing potential (WOCBP), UNLESS meeting the protocol definition of post-menopausal, OR are using one or more of the acceptable methods of contraception described in the protocol
研究者
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