A randomized control trial to compare the efficacy and safety of topical trifarotene 0.005 percent cream versus adapalene 0.1 percent gel in mild to moderate acne vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of topical trifarotene 0.005% cream versus adapalene 0.1% gel in mild to moderate acne vulgaris.
研究概览
简要总结
· After screening, all patients with active acne (comedones, papules and pustules) will be chosen.
· Before starting treatment, detailed history, clinical examination of patients will be done.
· The patient will be informed about the treatment given and possible local side effects like dryness, erythema and irritation which might occur.
· Informed written consent will be taken from each patient
· In case of minor patients, the informed written consent will be taken from the parent/guardian
· Data will be collected by a single examiner and recorded in case proforma.
· Patients will be randomly divided into two equal groups, Group A and Group B
· Patients of Group A will be asked to apply adapalene 0.1% gel once daily for 12 weeks
·
Patients of Group B will be asked to apply trifarotene 0.005% cream once daily for 12 weeks · Both the groups will be provided with skin care products including identical gentle non-comedogenic cleanser, moisturizer and sunscreen
· Digital photographs of the face and trunk will be taken using identical camera settings, patient positioning and room lighting at baseline and at 12 weeks.
· After 12 weeks, the digital photographs will be compared with baseline.
· Physician’s assessment of improvement will also be recorded by Investigator’s Global Assessment (IGA) score for facial and truncal acne
· The efficacy of the treatment will be calculated based on percent of clearance of lesions
· The safety of the treatment will be assessed by the side effects associated with the treatment
· Patient’s assessment of improvement will be recorded by visual analog scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 10.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All patients aged from 10 to 50 years with active acne willing to come for regular follow up 2.No history of topical treatments for two weeks, dermatologic procedures such as laser therapy, deep chemical peeling for four weeks, systemic medications like corticosteroids, antibiotics, or spironolactone for four weeks; and 12 weeks for oral retinoids/isotretinoin, cyproterone acetate, and immunomodulators when enrolled in the study 3.Patients with facial and truncal acne defined by Investigator’s Global Assessment (IGA) score of 1 to 3 (mild to moderate).
排除标准
- •1.Patients with facial and truncal acne defined by Investigator’s Global Assessment (IGA) score of 4 (severe) 2.Acne conglobates, acne fulminans, secondary acne, drug induced acne, nodulocystic acne, or acne requiring systemic treatment 3.≥ 3 excoriated lesions 4.Pregnant or lactating women or plan to conceive during study period 5.Known or suspected allergies to study drugs 6.Any concomitant skin conditions over the face 7.Immunosuppressed patients.
结局指标
主要结局
To evaluate the efficacy of topical trifarotene 0.005% cream versus adapalene 0.1% gel in mild to moderate acne vulgaris.
时间窗: one year
次要结局
- To evaluate the safety profile of topical trifarotene 0.005% cream versus adapalene 0.1% gel in mild to moderate acne vulgaris.(one year)
研究者
Dr E Sushnitha Johnson
Jawaharlal Nehru Medical College Belagavi-590010, Karnataka.