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临床试验/CTRI/2024/12/078197
CTRI/2024/12/078197尚未招募不适用

Comparitive efficacy of topical Trifarotene and Tretinoin in acne vulgaris

Government Medical College and Hospital Chandigarh1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年12月26日最近更新:

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

发起方
Government Medical College and Hospital Chandigarh
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Mala Bhalla

Government Medical College and Hospital Chandigarh

研究点 (1)

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