Comparitive efficacy of topical Trifarotene and Tretinoin in acne vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.Percentage improvement and reduction in the total lesion count from the baseline
研究概览
简要总结
Patients of clinically diagnosed acne vulgaris attending the Out Patient Department of Dermatology ,GMCH Chandigarh will be recruited for the study after written informed consent into 2 groups of 25 each.
Group 1-Pateints receiving topical tretinoin 0.025% cream Local application at night
Group 2-Patients receiving topical trifarotene 0.005% cream Local application at night
Clinical evaluation and photographic assessment will be done at baseline (first visit) and at each follow up visit (3, 6, 9 and 12 weeks). Response of the therapy will be measured by the objective measure of total lesion count and percentage reduction compared from baseline**.**The improvement will be graded as below:
Nil: 0-25% reduction in lesions
Mild: 26-50% reduction in lesions
Moderate: 51-75% reduction in lesions
Good: 76-100% reduction in lesions
Patients will be informed about the likely side effects of topical retinoids such as dryness, erythema, skin irritation, skin peeling, itching, stinging, exacerbation of lesionsetc and will be asked to note, grade and report these to the treating physician. Adverse effects reported by participants will be categorized according to the Numeric Rating Scale (NRS) in which each adverse effect will be assigned a numerical score ranging from 0 to 10, with 0 representing no side effect and 10 representing an extremely severe side effect. If exacerbation, in terms of inflammatory nodular predominant lesions, or if unwilling for further continuation, the patients shall be excluded from the study and managed with alternative therapies requiring systemic antibiotics or retinoids. In case the patients complain of excessive dryness (Numeric Rating Scale 7 or more), they will be asked to stop the medication for three days, restart and if dryness persists or increases, patients shall be taken out of the study. Owing to increased photosensitivity after the use of topical retinoids, the patients shall be advised for strict photoprotection both by the use of non comedogenic sunscreen as well as physical protection.
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
- 16.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients of acne vulgaris (grade 1 & 2)involving face and not requiring systemic therapy 2.Patients of 16-50 years of age.
排除标准
- •1.Pregnant and lactating mothers 2.Patients with severe systemic illness requiring systemic therapy of more than 4 weeks 3.Patients with signs and symptoms of hyperandrogenism 4.Patients with truncal acne.
结局指标
主要结局
1.Percentage improvement and reduction in the total lesion count from the baseline
时间窗: At Baseline,3 weeks,6 weeks,9 weeks and 12 weeks.
2.Reduction in total lesion count assessed through clinical photography
时间窗: At Baseline,3 weeks,6 weeks,9 weeks and 12 weeks.
次要结局
- 1.Patient-reported outcomes: Evaluation of treatment satisfaction & improvement in acne.(2.Adverse effects: Monitoring & categorization of adverse events related to each treatment using the Numeric Rating Scale .)
研究者
Dr Mala Bhalla
Government Medical College and Hospital Chandigarh
