EUCTR2010-022912-37-Outside-EU/EEA进行中（未招募）不适用
Multi-centre, open-label, long-term safety trial to assess the long-term safety of tretinoin clindamycin phosphate gel in patients from 12 to less than 18 years of age with acne vulgaris.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 442
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 of female subjects of any race;
- •12 years of age or older;
- •Mild, moderate or severe acne vulgaris.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 242
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Participation in a clinical drug or device research study within 30 days of enrollment or participation in a research study concurrent with this study;
- •2.Any dermatological conditions on the face that could have interfered with clinical evaluations, such as acne conglobata, acne fulminans, secondary acne, etc.;
- •3.History of regional enteritis, ulcerative colitis or antibiotic-associated colitis;
- •4.Treatment of any type for cancer within the last 6 months;
- •5.History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator’s Brochure, including known sensitivities to any dosage form of clindamycin, lincomycin or tretinoin;
- •6.Use of the following at Screening/Baseline:
- •topical antibiotics on the facial area (Azelaic Acid, erythromycin);
- •anti-inflammatories and corticosteroids on the face;
- •topical retinoids, including retinol, on the face.
研究者
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