A Pilot Study to Evaluate the Efficacy of Fixed Dose Combination Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel Alone Versus Fixed Dose Combination Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel Plus Benzoyl Peroxide 6% Foaming Cloths in the Treatment of Facial Acne Vulgaris
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in PGA scores of patients using combination clindamycin phosphate 1.2%/tretinoin 0.025% gel with or without benzoyl peroxide 6% foaming cloths for facial acne
研究概览
简要总结
There are many different factors that cause acne. So combination treatment using different medications that can address these different factors is commonly used to treat acne. Fixed-dose combination clindamycin phosphate 1.2% and tretinoin 0.025% gel and benzoyl peroxide 6% foaming cloths are both used to treat acne. This study will evaluate the use of the medications when used together.
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 (Investigator)
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 use adequate birth control during the study (barrier, oral, injection, intrauterine or abstinence).
- •Clear diagnosis of facial acne vulgaris for at least 3 months.
- •Subject must have a static Physician's Global Assessment (PGA) of at least 2 (mild severity), but no more than
- •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 study drug.
- •Subjects with very severe acne (PGA score of 5)
- •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 2 weeks of entering the study.
- •Subjects taking birth control pills for less than 3 months or solely for the prevention of acne.
- •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.
研究组 & 干预措施
clindamycin phosphate 1.2%/tretinoin 0.025% gel alone
干预措施: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone (Drug)
clindamycin / tretinoin gel plus benzoyl peroxide
干预措施: clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths (Drug)
结局指标
主要结局
Change in PGA scores of patients using combination clindamycin phosphate 1.2%/tretinoin 0.025% gel with or without benzoyl peroxide 6% foaming cloths for facial acne
时间窗: Weeks 2, 4, 8, 12
The primary efficacy endpoint will be "Treatment Success", a static endpoint defined as a score of 0 (clear) to 1 (almost clear) at Week 12 (final study visit) by PGA scoring system.
次要结局
- Total number of adverse events.(Weeks 2, 4, 8, 12)
- Change in Postinflammatory hyperpigmentation score at each study visit and from baseline to final visit.(Weeks 2, 4, 8, 12)
- Change in Subject Self Assessment Scoring Scale(Weeks 2, 4, 8, 12)
- Change in Acne-Specific Quality of Life Questionnaire (Acne-QoL)(Weeks 2, 4, 8, 12)
研究者
Joshua Zeichner
Zeichner, Joshua, M.D.
Icahn School of Medicine at Mount Sinai