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临床试验/CTRI/2024/12/077823
CTRI/2024/12/077823尚未招募3 期

Comparative Efficacy of Topical Calcitriol versus Topical Adapalene in the Treatment of Mild and Moderate Acne: A Randomized controlled trial

Dr Aditi Shende1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月17日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1. Reduction in total lesion count (Total, Inflammatory and Non-inflammatory)

研究概览

简要总结

Acne vulgaris is one of the most common dermatological conditions characterized by comedones, papules, pustules, nodules, and cysts in severe cases. Multiple options for managing mild and moderate acne include topical retinoids, benzoyl peroxide, minocycline, topical clindamycin, and oral antibiotics. However these are associated with multiple adverse effects like increasing antibiotic resistance and retinoid dermatitis. Hence, there is a need to evaluate newer therapeutic options for acne. With the increasing role of Vitamin D in the pathophysiology of acne, there is a need for a study comparing the efficacy of topical vitamin D analogs like calcitriol with adapalene in the treatment of mild and moderate acne. The objective of this study is to compare the efficacy and safety profile of topical calcitriol versus topical adapalene in the treatment of mild and moderate acne.

A Randomized controlled trial will be conducted to assess the efficacy and safety profile of two treatment options in patients with mild and moderate acne vulgaris: topical 0.0003% calcitriol ointment and topical 0.1% adapalene gel. This study will be conducted after approval from the institutional ethics committee. The patients fulfilling the inclusion criteria will be enrolled in the study. Written informed consent will be taken from each patient. A detailed history including demographic details (age, sex), family history, signs of polycystic ovary syndrome (PCOS), and history of acne vulgaris (age of onset, duration, any prior treatment history) will be recorded. Clinical examination will be done for acne type, site of involvement, lesion count (inflammatory and non-inflammatory), and severity of acne using Global acne grading system score. Patients will be randomly divided into two groups. Group 1 patients will receive topical calcitriol and group 2 patients will receive topical adapalene. Patients will be asked to apply the creams daily at night for 12 weeks. Patients will be asked to follow up at 4, 8 and 12 weeks. At each follow-up visit patients will be assessed for the primary outcome (reduction in total lesion count and acne severity using global acne grading system score) and the secondary outcome (safety profile). A photographic record will be maintained. At every follow-up visit, patients will be assessed for adverse effects like erythema, itching, scaling, and burning sensation on a 4-point 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
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Age 18 years or older, of either gender and any racial/ethnic group with mild (GAGS score 1-18) and moderate acne (GAGS score 19-30) according to Global Acne Grading System (GAGS)
  • Subjects must understand and sign the informed consent before participation.

排除标准

  • Severe acne (GAGS score more than 30)
  • Pregnancy or breastfeeding
  • History of hypersensitivity or allergic reaction to study medications
  • On topical treatment (4 weeks before participation) or systemic treatment (3 months before enrolment) for acne
  • Any concomitant dermatological or systemic illness
  • Patients who are unable to follow up.

结局指标

主要结局

1. Reduction in total lesion count (Total, Inflammatory and Non-inflammatory)

时间窗: 0, 4 weeks, 8 weeks and 12 weeks

2. Reduction in acne severity

时间窗: 0, 4 weeks, 8 weeks and 12 weeks

and global acne grading score

时间窗: 0, 4 weeks, 8 weeks and 12 weeks

次要结局

  • Safety profile of both the topicals graded on 4 point scale(0, 4 weeks, 8 weeks and 12 weeks)

研究者

发起方
Dr Aditi Shende
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Aditi Shende

Symbiosis Medical College for Women and SUHRC

研究点 (1)

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