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临床试验/NCT05471947
NCT05471947已完成4 期

Use of TCA 15% + 3% Glycolic Acid Chemical Peel for Improvement in Hand Lentigines

Main Line Center for Laser Surgery1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Improvement in hand lentigines on a 5-point scale

研究概览

简要总结

This study will evaluate the efficacy of the a 15% trichloroacetic acid + 3% glycolic acid peel combination for treatment of lentigines on the hands. This peel combination is sold over the counter. Patients will receive 3 treatments (spaced 4 weeks).

详细描述

This clinical investigation is a prospective study consisting of a screening visit, 3 treatment visits, and 1 follow-up visit. Baseline and post-treatment photos will be graded and compared.

A total of 20 patients will be recruited. Following informed consent and screening, subjects' dorsal hands will be photographed.

Patients will receive 3 treatments with the 15% TCA + 3% glycolic acid peel every 4-6 weeks on the dorsal hands. Post-treatment, patients will be instructed to apply Aquaphor to the treated area twice daily for 5 days. Patients' hands will be photographed at each visit.

Four to six weeks after their final treatment, subjects will return for photography.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
22 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • No laser, chemical peel, neuromodulator, filler treatment to the hands in >3 months
  • At least 5 lentigines on each hand

排除标准

  • Pregnancy
  • Breastfeeding
  • Allergy to trichloroacetic acid
  • Allergy to glycolic acid
  • Open wounds on treatment area (hands)
  • Active inflammatory disease on treatment area such as atopic dermatitis, psoriasis, dermatomyositis

研究组 & 干预措施

Treatment

Experimental

Treatment of hand lentigines with 15% trichloroacetic acid + 3% glycolic acid

干预措施: 15% Trichloroacetic acid + 3% glycolic acid (Drug)

结局指标

主要结局

Improvement in hand lentigines on a 5-point scale

时间窗: 4-6 weeks after last treatment

Photos will be graded on a 5 point scale (0=no change, 1=1-25% change, 2=26-50% change, 3=51-75% change, 4=76-100% change)

次要结局

  • Improvement in hand lentigines using the Global Aesthetic Improvement Scale(4-6 weeks after last treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kachiu Lee, MD

Principal Investigator

Main Line Center for Laser Surgery

研究点 (1)

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