A Single-blind, Randomized, Comparative Split-face Study Evaluating the Tolerability of Clindamycin and Benzoyl Peroxide Gel to Benzoyl Peroxide/Adapalene Gel in the Treatment of Acne Vulgaris.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Skin Peeling Score
研究概览
简要总结
Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
详细描述
Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks and consists of a baseline visit and visits at weeks 1, 2, 5 and 8. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3 subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Blinding This is an investigator-blinded study; therefore, subjects and study-center staff will not be blinded to study treatment allocation (ie, left vs. right side application). During the first 2 weeks, the investigator will be unaware of which study product is being used on either side of the face. Subjects and study-center staff will be instructed not to reveal study treatment allocation to the investigator. Subjects will be instructed not to use study product in the presence of the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects at least 18 years of age, in good general health with documented diagnosis of facial acne vulgaris.
- •Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
- •Subjects willing to follow therapeutic instructions including avoidance of any other topical facial or systemic acne therapy during the conduct of the study.
- •Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
排除标准
- •Female subjects who are pregnant, trying to become pregnant or breastfeeding.
- •Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases, diseases of the facial skin, other than acne vulgaris.
- •Facial hair that may obscure the accurate assessment of acne grade.
- •History or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
- •Use of topical antibiotics on the face and systemic antibiotics within the past 2 and 4 weeks, respectively.
- •Use of topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
- •Use of systemic retinoids within the past 6 months.
- •Concurrent use of drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
- •Concomitant use of neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
- •Use of topical anti-acne medications within the past 2 weeks.
- •Use of any investigational drugs or treatments during the study or within 4 weeks of the baseline visit.
研究组 & 干预措施
Duac gel
Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks.
干预措施: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel) (Drug)
Epiduo gel
Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks.
干预措施: benzoyl peroxide and adapalene gel (EPIDUO™ Gel) (Drug)
结局指标
主要结局
Skin Peeling Score
时间窗: Week 1, Week 2
Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3.
Erythema (Redness) Score
时间窗: Week 1, Week 2
Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Skin Dryness Score
时间窗: Week 1, Week 2
Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Irritant/Allergic Contact Dermatitis Score
时间窗: Week 1, Week 2
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face. Erythema,peeling, and dryness were graded using the following scale: 0 None 1. Slight 2. Moderate 3. Intense
次要结局
- Skin Dryness Score(Week 5, Week 8)
- Skin Peeling Score(Week 5, Week 8)
- Skindex-29 Quality of Life Questionnaire - Symptomatic Domain(Baseline, and Week 8)
- Skindex-29 Quality of Life Questionnaire - Functional Domain(Baseline, and Week 8)
- Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin(Week 8)
- Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product(Week 8)
- Investigator Static Global Assessment Score(Week 5, Week 8)
- Non-Inflammatory Acne Lesion Counts(Week 5, Week 8)
- Total Acne Lesion Counts(Week 5, Week 8)
- Product Acceptability and Preference Questionnaire - Compliance(Week 8)
- Erythema (Redness) Score(Week 5, Week 8)
- Irritant/Allergic Contact Dermatitis Score(Week 5, Week 8)
- Skindex-29 Quality of Life Questionnaire - Global Score(Baseline, and Week 8)
- Product Acceptability and Preference Questionnaire - Severity of Redness(Week 8)
- Product Acceptability and Preference Questionnaire - Severity of Burning(Week 8)
- Product Acceptability and Preference Questionnaire - Comfort of Skin(Week 8)
- Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?(Week 1, Week 2)
- Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past(Week 8)
- Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment(Week 8)
- Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up(Week 8)
- Inflammatory Acne Lesion Counts(Week 5, Week 8)
- Skindex-29 Quality of Life Questionnaire - Emotional Domain(Baseline, and Week 8)
- Product Acceptability and Preference Questionnaire - Severity of Dryness(Week 8)
- Product Acceptability and Preference Questionnaire - Severity of Itching(Week 8)
- Product Acceptability and Preference Questionnaire - Severity of Scaling(Week 8)
- Product Acceptability and Preference Questionnaire - Ease of Application of Product(Week 8)
- Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products(Week 8)