NCT01448733Unknown4 期
A Pilot Study to Evaluate the Safety and Tolerability of CeraVe® Lotion Followed by Fixed Dose Clindamycin Phosphate 1.2% / Benzoyl Peroxide 2.5% Gel in the Morning in Combination With CeraVe® Lotion Followed by Tretinoin 0.05% Gel in the Evening for the Treatment of Facial Acne Vulgaris.
Zeichner, Joshua, M.D.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cutaneous Tolerability of Combination Therapy of Acanya Gel with Atralin Gel for the treatment of acne vulgaris
研究概览
简要总结
The purpose of this study is to evaluate whether Cerave lotion followed by Acanya Gel in the morning in combination with Cerave lotion followed by Atralin gel in the evening is safe and effective for the treatment of acne vulgaris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ≥ 12 years old.
- •Subjects must be in good general health as confirmed by medical history and physical examination.
- •Females of child-bearing potential must have a negative urine pregnancy test at the baseline visit and agree to be abstinent or use adequate birth control during the study (oral contraceptives, Norplant, Depo-Provera, or double barrier methods (e.g., condom and spermicide).
- •Clear diagnosis of facial acne vulgaris for at least 6 months.
- •Subject must have a static Physician's Global Assessment (PGA) of 2 (mild severity) or 3 (moderate severity).
- •Disease must be stable or slowly worsening for more than one week prior to entering the study.
- •Subjects or their guardians must be able to read, sign, and date the informed consent, and abide by study restrictions for its duration.
排除标准
- •Females who are pregnant, attempting to conceive, or breastfeeding.
- •Subjects with known hypersensitivity to any ingredients in the study drugs.
- •Subjects with overt signs of skin atrophy, telangiectasias or other skin findings that would affect efficacy evaluation.
- •Subjects with a current active skin malignancy or infection.
- •Subjects requiring the use of medications known to alter the course of acne vulgaris during the study treatment.
- •Subjects who have received systemic antibiotics within 2 weeks.
- •Subjects using systemic corticosteroids or immunosuppressants within 28 days of entering the study.
- •Subjects who have received any topical therapies for acne vulgaris within 7 days of entering the study.
- •Subjects taking birth control pills used solely for acne control.
- •Subjects who are currently participating in or, within the previous 28 days, have participated in another study for the treatment of acne vulgaris.
- •Subjects with clinical conditions that may post a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.
- •Subjects who have Crohn's disease, colitis, or if subjects ever developed colitis or severe diarrhea with past antibiotic use.
研究组 & 干预措施
Acanya Plus Atralin
Experimental
A single, open-label arm treating acne with Cerave lotion plus Acanya gel in the morning in combination with Cerave lotion plus Atralin gel in the evening.
干预措施: Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the evening (Drug)
结局指标
主要结局
Cutaneous Tolerability of Combination Therapy of Acanya Gel with Atralin Gel for the treatment of acne vulgaris
时间窗: 12 weeks
Evaluation of skin erythema, scaling, drying, and stinging/burning
次要结局
- Efficacy of Combination Therapy of Acanya Gel with Atralin Gel for the treatment of acne vulgaris(12 weeks)
研究者
Joshua Zeichner
Director of Cosmetic and Clinical Research, Mt Sinai Dermatology
Zeichner, Joshua, M.D.
研究点 (1)
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