跳至主要内容
临床试验/CTRI/2026/03/106639
CTRI/2026/03/106639尚未招募不适用

Efficacy and safety of tinted vs non-tinted sunscreen use in topical steroid damaged face (TSDF): A Randomized controlled trial

ATUL KEJARIWAL1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年4月11日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Change in Dermoscopy-Assisted Topical Steroid-Damaged Face Severity (DATS) score from baseline to 8 weeks between the two groups.

研究概览

简要总结

This randomized controlled trial aims to evaluate and compare the efficacy and safety of tinted versus non-tinted sunscreens in the management of Topical Steroid Damaged Face (TSDF). TSDF results from prolonged, unsupervised use of topical corticosteroids on facial skin, leading to erythema, atrophy, telangiectasia, and pigmentary changes. Photoprotection plays a crucial role in treatment, and tinted sunscreens containing iron oxides may provide superior protection by blocking both ultraviolet (UV) and visible light, unlike conventional non-tinted formulations. Seventy patients diagnosed with TSDF will be randomized into two groups: one receiving tinted sunscreen and the other non-tinted sunscreen, both combined with emollient therapy and sun-avoidance measures. Efficacy will be assessed using the Dermoscopy-Assisted Topical Steroid-Damaged Face Severity (DATS) score, Physician Global Assessment (PGA), and Dermatology Life Quality Index (DLQI) at baseline, 4 weeks, and 8 weeks.

The study hypothesizes that tinted sunscreen will result in superior clinical and dermoscopic improvement, along with better quality-of-life outcomes, compared to non-tinted sunscreen.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •history of topical steroid use for more than 1 month.

排除标准

  • •systemic corticosteroid use within the last 1 month
  • •pregnant or lactating females.

结局指标

主要结局

Change in Dermoscopy-Assisted Topical Steroid-Damaged Face Severity (DATS) score from baseline to 8 weeks between the two groups.

时间窗: 0, 4 and 8 weeks

次要结局

  • 1.Change in Physician Global Assessment (PGA) score from baseline to 8 weeks(2. Change in Dermatology Life Quality Index (DLQI) from baseline to 8 weeks.)

研究者

发起方
ATUL KEJARIWAL
申办方类型
Other [SELF FUNDED]
责任方
Principal Investigator
主要研究者

ATUL KEJARIWAL

KALINGA INSTITUTE OF MEDICAL SCIENCES,BHUBANESHWAR,ORISSA

研究点 (1)

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