EUCTR2004-002272-41-GB进行中（未招募）不适用
A Multi-Centre, Single-Blind, Parallel Group, Clinical Evaluation of the Efficacy and Safety of Duac Gel (A Gel containing Clindamycin Phosphate [Equivalent to 1% Clindamycin] and 5% Benzoyl Peroxide) and Differin Gel (A Gel containing 0.1% Adapalene) in the Topical Treatment of Mild to Moderate Acne Vulgaris.
Stiefel Laboratories International Division0 个研究点目标入组 130 人开始时间: 2005年6月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
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) Patients with mild to moderate acne vulgaris of the face with at least 15 inflammatory lesions and/or non-inflammatory lesions, but no mre than three nodulocystic lesions and an acne grade of greater than 2 and less than 7.0 (The Leeds Revised Acne Grading System).
- •2) Patients of either sex aged between 12 and 39 years, inclusive.
- •3) Patients who are willing and able to provide written informed consent, after being informed of all the pertinent aspects of the trial. In the case of patients aged under 16 years of age, parental or guardian consent must be obtained in addition to patient assent.
- •4) Patients agreeing not to use sun-beds or undergo any UV light treatment and to minimise the amount of exposure to direct sunlight for the duration of the study.
- •5) Patients agreeing to minimise their alcohol comsumption throughout the study, with a limit of 14 units per week.
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Female patients who are pregnant, breast-feeding, or sexually active and not usinig reliable contraception and/or not prepared to do so for the duration of the trial (a negative pregnancy test must be confirmed at Visit 1, for all females if menarche has occurred).
- •2) Patients using anti-androgen containing contraceptives.
- •3) Patients who, during the past month, have received oral or topical steriods, oral or topical antibiotics, or acne treatment of any type, including natural or artifical UV therapy.
- •4) Patients who have history of hypersensitivity or idiosyncratic reaction to clindamycin phosphate, benzoyl peroxide, adapalene or any components of the study medications.
- •5) Patients using, or having used in the past month, any significant concomitant medication which might affect their acne, as judged by the Investigator.
- •6) Patients with severe systemic diseases (e.g., severely impaired renal or liver function, severe cardiovascular, neurological disease, or any other diseases that may interfere with the evaluation of the study medications). This also applied to patients with psoriasis, acne rosacea, allergic rashes, bacterial, viral or fungal infections of the facial skin, or other diseases of the facial skin.
- •7) Patients with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
- •8) Patients who have a history of photosensitivity.
- •9) Patients who are unreliable or unlikely to be avilable for the duration of the follow-up.
- •10) Patients who have participated in a clinical trial involving a drug within 30 days of recruitment into the study (or are likely to do so at any time during their participation).
- •11) Patients who are either an immediate family member, or a colleague, of study personnel.
- •12) Patients who already have a member of their household entered onto this trial.
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