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临床试验/NCT07060157
NCT07060157尚未招募不适用

Comparative Efficacy of Resveratrol 1 % Gel and Trichloroacetic Acid 20% in Treatment of Melasma: A Split-face Study

Assiut University1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2025年7月22日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
41
试验地点
1
主要终点
The primary outcome is the change in hemi-Melasma Area and Severity Index (hemi-MASI) score from baseline to one month after the end of treatment (follow-up)

研究概览

简要总结

  1. To evaluate the efficacy and safety of topical resveratrol 1 % gel in treatment of melasma.
  2. To compare between the efficacy of topical resveratrol 1 %gel versrs chemical peeling with TCA 20% in melasma.

详细描述

Melasma is a chronic, acquired disorder of focal hypermelanosis. It clinically presents as hyperpigmented patches over photo-exposed areas (Espósito.,et al 2022). Melasma classified clinically into; Centrofacial, malar, mandibular, indeterminate , and extrafacial types . By wood's lamp ,melasma classified into epidermal, dermal, and mixed forms (Putra Gofur N et al . , 2021) .

Chronic ultraviolet (UV) exposure, genetic factors, and sex hormones are generally believed to be involved in the occurrence of melasma. Other factors implicated are phototoxic drugs, anticonvulsant medications, and the use of certain cosmetics (Ortonne et al., 2009).

Treating melasma is challenging especially in patients with dark skin types , classified as Fitzpatrick types IV to VI, due to the possibility of relapse and susceptibility to post-inflammatory hyperpigmentation (PIH) (Rodrigues and Pandya., 2015).

Although various therapeutic approaches including pharmacological and procedural treatments have been considered in melasma management, none of them is completely satisfactory (Rodrigues and Pandya., 2015).

Ongoing clinical trials continue to explore new topical treatment options for melasma, aiming to develop more effective and safer alternatives with fewer side effects. Traditional agents like hydroquinone remain the gold standard, but concerns over irritation and potential long-term risks have driven research into novel formulations. (Christian and Michelle.,2024) .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Age: 18-50 years old.
  • Pattern of melasma: Bilateral symmetrical facial melasma of any pattern.
  • Fitzpatrick skin phototypes: Types III, IV and V.

排除标准

  • Pregnancy and lactation.
  • Patients taking oral contraceptive pills, hormonal replacement therapy or treatment for chronic illness at the time of the study or during the past 6 months.
  • Coexistence of diseases associated with hyperpigmentation such as Addison disease.
  • History of Scarring and keloid tendency
  • Active skin infections as active HSV.
  • Previous history of post- inflammatory hyperpigmentation.

研究组 & 干预措施

Group A

Active Comparator

left side of face the patient will be given resveratrol 1 % gel once daily at night (homThee use ).

干预措施: resveratrol 1 % gel (Drug)

Group B

Active Comparator

The right side of face will treated with TCA20% every two weeks for 3months.

干预措施: TCA20% (Drug)

结局指标

主要结局

The primary outcome is the change in hemi-Melasma Area and Severity Index (hemi-MASI) score from baseline to one month after the end of treatment (follow-up)

时间窗: 3 months

assessed by clinical evaluation and photographic documentation. Clinical efficacy will be categorized as: Excellent response: \>75% decrease in hemi-MASI score Very good response: 50-75% decrease in hemi-MASI score Good response: 25-50% decrease in hemi-MASI score Poor response: \<25% decrease in hemi-MASI score

次要结局

未报告次要终点

研究者

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

Amira Mohamed Bakry Refaay

doctor

Assiut University

研究点 (1)

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