Efficacy and safety of tinted vs non-tinted sunscreen use in topical steroid damaged face (TSDF): A Randomized controlled trial
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
- 干预性
- 分配方式
- 随机
- 随机化方法
- 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 2.
- 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
ATUL KEJARIWAL
KALINGA INSTITUTE OF MEDICAL SCIENCES,BHUBANESHWAR,ORISSA
研究点 (1)
标识符
- CTRI 编号
- CTRI/2026/03/106639
日期
- 最近更新
- (6个月前)
