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临床试验/CTRI/2025/07/092054
CTRI/2025/07/092054尚未招募4 期

Efficacy and safety of Tazarotene 0.1% cream versus Salicylic acid 12% ointment in fissured feet: A randomized controlled study

Kalinga Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年8月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Topical tazarotene 0.1% cream has equivalent efficacy in treatment of fissured feet in comparison to salicylic acid 12% ointment

研究概览

简要总结

Fissured feet, a common yet neglected dermatosis, cause significant morbidity due to pain, cracking, and potential secondary infections. While keratolytic agents like salicylic acid are commonly used, treatment remains inconsistent in efficacy. Tazarotene 0.1% cream, a third-generation topical retinoid approved for psoriasis, has demonstrated keratinocyte-modulating and anti-inflammatory properties, making it a potential novel agent for managing fissured feet. However, its use in this indication is largely unexplored.

This randomized, interventional, prospective study aims to compare the efficacy and safety of topical tazarotene 0.1% cream versus salicylic acid 12% ointment in the treatment of fissured feet. A total of 80 patients (40 per group) attending the dermatology outpatient department at Kalinga Institute of Medical Sciences will be enrolled between March 2024 and March 2026. Participants will be randomly assigned to two groups: Group A will receive tazarotene 0.1% cream and Group B will receive salicylic acid 12% ointment, both applied once daily for 90 days, alongside a bland emollient.

Outcomes will be assessed through clinical scoring, photographic documentation, and symptom relief at 30-day intervals. Primary endpoints include reduction in fissure depth, pain, and callus formation; secondary endpoints include adverse effects and patient compliance.

The study addresses an important therapeutic gap in managing heel fissures, especially in the Indian context where socio-cultural factors exacerbate the condition. Findings may offer dermatologists an evidence-based, steroid-sparing alternative with better cosmetic outcomes

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All patients willing to give consent 2.Untreated fissuring of feet or xerosis.

排除标准

  • 1.Pregnant and lactating females 2.Non consenting participants 3.Immunocompromised patients 4.Skin disorders affecting the foot such as infections, dermatitis, psoriasis, un-healed skin wounds, ulcers or blisters.
  • 5.Any participant with a known systematic disease including peripheral vascular disease or musculoskeletal disorders of the foot or ankle, rheumatoid arthritis will be excluded.

结局指标

主要结局

Topical tazarotene 0.1% cream has equivalent efficacy in treatment of fissured feet in comparison to salicylic acid 12% ointment

时间窗: Follow up will be done every month. Final assessment will be done after 3 months

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Priyanshi Tyagi

Kalinga Institute of Medical Sciences

研究点 (1)

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