A RANDOMISED CONTROL TRIAL TO EVALUATE THE EFFECTIVENESS AND SAFETY OF TRIFAROTENE 0.005% AND ADAPALENE 0.1% IN TREATMENT OF MILD AND MODERATE ACNE VULGARIS
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Reduction of acne
研究概览
简要总结
A total of 118 above 18 years after excluding using exclusion criteria mild to moderate acne vulgaris patients are divided into 2 groups with 59 in each. Group A- TRIFAROTENE 0.005 percentage is given for 12 weeks and group B- ADAPALENE 0.1 percentage is given for 12 weeks. Patient are asked to visit at 0,4,8,12 weeks . At each visit acne is assessed using parameters like investigators global assessment IGA score and global acne grading system GAGS and photographs are taken at each visit. The expected benefits that is efficacy are reduction in acne , post inflammatory hyperpigmentation, improvement in texture and contour of the skin which is assessed with counting the no.of open, closed comedones, papules, pustules along with photographs taken during each visit. The adverse effects like erythema, burning, dryness, itching, peeling of the skin is also assessed which accounts for the safety party of the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients attending SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE Dermatology OPD and diagnosed with Acne Vulgaris.
- •Patients willing to take topical medication for Acne vulgaris.
- •Patients providing voluntary informed and written consent for the explained treatment modality .
- •Patient age 18 years and older.
- •Patient of either sex with mild and moderate facial acne according to IGA score (Investigators global assessment ) score and GAGS ( Global Acne Grading System).
排除标准
- •Severe form of acne Greater than one nodule on the face Presence of acne cysts, excessive beard, facial hair that could interfere with study assessments.
- •Known or suspected allergies or sensitivities to the planned study drug.
- •Intent to conceive during the study in women .
- •Lactating mothers during the study Patients who have not given written consent for participation in study.
结局指标
主要结局
Reduction of acne
时间窗: 4 weeks - reduction of comedones along with redness | 8 weeks- reduction of comedones along with pustules | 12 weeks- reduction of comedones, pustules, redness and decrease in recurrence of acne.
次要结局
- Reduction of acne scars, improvement of texture(4 weeks - improvement in erythema)
研究者
Dr Kallepu Rishika Sagar
S.R.M medical college hospital and research centre