A COMPARATIVE STUDY OF EFFICACY AND SAFETY OF TOPICAL CLINDAMYCIN 1% GEL VERSUS TOPICAL DAPSONE 5% GEL IN ACNE VULGARIS OVER FACE: A PROSPECTIVE RANDOMIZED DOUBLE BLIND STUDY.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To observe the efficacy of Test Drugs on lesion count in the patients of Acne Vulgaris over face.
研究概览
简要总结
As there is a knownresistance to certain antibiotics, such as macrolides and quinolones, used totreat acne, and a handful adverse effects are associated to other systemictherapies, like retinoids, and many people prefer topical treatments tosystemic ones, the best topical therapy is sought after. We therefore,considered comparing the efficacy of 5% dapsone gel with a proven therapyoption, such as 1% clindamycin gel.
This study is an interventional, double blind, prospective, randomized and comparative study.
There are 2 groups : Clindamycin 1% gel group and Dapsone 5% gel group. Both these drugs are compared for their efficacy in Acne Vulgaris over face.
At baseline visit, Total lesion count and ISGA score of the patient will be noted and patients will be randomized for their distribution in either of the given groups.
2nd visit will be at 4 weeks, 3rd visit will be at 8 weeks and 4th visit will be at 12 weeks.
The primary purpose is to study the efficacy of both drugs for acne vulgaris over face by observing the changes in their ISGA score and Total Lesion Count, tocompare the efficacy betweenboth the groups, toevaluate and compare the safety profile between the test drugs in patients of AcneVulgaris over face.
The secondary objective is to evaluate the impact of AcneVulgaris on quality of life of patients.
Hypothesis : Bythis comparative study,in our institute we will find out whethereither one of the test drug is more efficacious and safer than the other ornot.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having ISGA scoring of 1 or more at baseline.
- •Patients who are willing to take part in the study with signed and written informed consent.
- •Patients could be of both male and female.
- •All patients who are 15-45 years of age Patient must be medically stable.
- •Patient must have active mobile number.
排除标准
- •Pregnant, breast feeding, child bearing age using contraception.
- •Patient with nodulocystic lesions (ISGA Grade 4 and ISGA Grade 5) at the baseline.
- •Patient with a K/C/O any Autoimmune conditions like SLE, Thyroid disorder, Vitiligo, etc.
- •Patient receiving systemic treatment relevant to Facial Acne Vulgaris within 3 months of enrollment.
- •Patient receiving Topical treatment relevant to Facial Acne within 1 months Patient who are on medications like topical facial antibiotics, topical acne medicines, topical corticosteroids within 2 weeks.
- •Patients who have undergone any facial procedures within 1 months.
- •Patients using any systemic retinoids or received treatment with estrogens or anti-androgenic agents within 2 months.
结局指标
主要结局
To observe the efficacy of Test Drugs on lesion count in the patients of Acne Vulgaris over face.
时间窗: 1st visit At baseline | 2nd visit at 4th week | 3rd visit at 8th week | 4th visit at 12th week
To compare the efficacy between both the groups.
时间窗: 1st visit At baseline | 2nd visit at 4th week | 3rd visit at 8th week | 4th visit at 12th week
To evaluate and compare the safety profile between the test drugs in patients of Acne Vulgaris over face.
时间窗: 1st visit At baseline | 2nd visit at 4th week | 3rd visit at 8th week | 4th visit at 12th week
次要结局
- To evaluate the impact of Acne Vulgaris on quality of life of patients(1st visit At baseline)