NCT00377000已完成4 期
A Pilot, Multi-Center, Patient Preference Study Comparing Two Clindamycin/Benzoyl Peroxide Gels.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 60
- 主要终点
- Patient Preference Questionnaire evaluation: including product use, patient knowledge and impression of acne, as well as patient treatment
研究概览
简要总结
Evaluate patient preference factors comparing two clindamycin/benzoyl peroxide gels. One dispensed in a pump presentation, the other in a tube presentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
- •INCLUSION CRITERIA:
- •Patients with a clinical diagnosis of acne vulgaris of mild to moderate severity
- •Females of childbearing potential, in addition to having a negative urine pregnancy test at Visit 1, must be willing to use an acceptable form of birth control during the study.
- •Patients 18 years of age or older must provide Institutional Review Board (IRB) approved written informed consent. Patients under 18 years of age must have IRB approved written informed consent from a parent or legal guardian. Patients 12 - 17 years of age must complete an IRB approved assent form for minors.
- •Patients must be willing and able to understand the requirements of the study, abide by the restrictions, apply the medication as instructed, and return for the required study visits.
- •Patients must be in good health and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations.
- •Patients who use make-up must have used the same brand of make-up for a minimum period of 2 weeks prior to Baseline and agree to not change make-up brands or types during the study.
排除标准
- •Patients who are pregnant, nursing, or planning a pregnancy within the study period.
- •Patients who have more than 2 nodulo-cystic lesions on the face, excluding the nose.
- •Patients who have a known hypersensitivity to any ingredients in the test products including clindamycin and benzoyl peroxide.
- •Patients who have been treated with prescription and/or over-the-counter topical products, or had a procedure performed that may impact study assessments.
- •Patients who have any systemic or dermatological disorder that has the potential to interfere with the evaluations (e.g., rosacea, seborrheic dermatitis, perioral dermatitis, corticosteroid-induced acne vulgaris, carcinoid syndrome, mastocytosis, acneform eruptions caused by medication, facial psoriasis, facial eczema, etc.).
- •Patients with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
- •Patients who engage in activities that involve excessive or prolonged exposure to sunlight.
- •Patients who consume excessive amounts of alcohol, abuse drugs, or have any condition that would compromise compliance with this protocol.
- •Patients who have been treated with an investigational drug or investigational device within a period of 30 days prior to study entry.
- •Alcoholic toners, astringents, medicated topical preparations (prescriptions and over-the-counter), or medicated make-up on the facial treatment area.
- •Abrasive cleansers or washes to the facial area.
- •New cosmetics, or new cleansers applied to the face.
- •Patients must not wear make-up at the visits, so as not to interfere with the evaluations.
- •Patients should not use a sauna within 48 hours prior to each visit.
结局指标
主要结局
Patient Preference Questionnaire evaluation: including product use, patient knowledge and impression of acne, as well as patient treatment
The incidence of all adverse events reported during the study will be summarized by treatment group
The signs and symptoms of irritation will be summarized descriptively by treatment group at every visit
Investigator irritation grading - erythema, peeling, dryness and pruritus at Baseline (Week 0), Week 2, 4, and 6
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
A Study CLBG and Benzoyl Peroxide Gel 1%/5% to BenzaClin® Gel in the Treatment of Acne VulgarisAcne VulgarisNCT02595034Taro Pharmaceuticals USA1,000
已完成
不适用
Clinical Performance and Safety Comparison of Stay Safe Link® With Stay Safe® in Patient on CAPD (CAPD-3)Continuous Ambulatory Peritoneal DialysisNCT03177031Penang Hospital, Malaysia472
已完成
4 期
Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne VulgarisAcne VulgarisNCT00160394Stiefel, a GSK Company130
已完成
3 期
Double-blind Placebo-controlled Trial of Generic Clindamycin/Benzoyl Peroxide Gel Versus Onexton Gel in Acne VulgarisAcne VulgarisNCT02616614Actavis Inc.862
撤回
不适用
Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine PatientsPain ReliefNCT01263652Western Galilee Hospital-Nahariya