A full-face baseline controlled study to evaluate the efficacy of Dermapen 4™ microneedling devicein conjunction with MG-BL serum for melasma treatment over 12 weeks

Equipmed USA LLC.1 个研究点分布在 1 个国家目标入组 55 人开始时间: 2025年4月13日最近更新: 2025年2月4日

试验速览

阶段: 2 期
状态: 尚未招募
发起方
入组人数: 55
试验地点: 1
主要终点: Change in mMASI score in comparison to baseline

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Melasma is a verycommon pigmentation disorder which significantly alters quality of life as perits high visibility on the face. This study has been designed to evaluate theeffectiveness of Dermapen 4™ microneedlingdevice with MG-BL serum formelasma treatment.

Dermatological evaluations for mMASI, IGA, self assessment questionnaire will be performed at baseline, weeks 2, 4, 6, 8 and 12.

研究设计

研究类型: Interventional
分配方式: Not Applicable
盲法: Not Applicable

入排标准

年龄范围: 18.00 Year(s) 至 50.00 Year(s)（—）
性别: Female

入选标准

•Fitzpatrick skin phototype III to VI.
•Subjects presenting with moderate facial Melasma.
•Subjects who have not used any depigmenting agents or undergone any melasma treatment in the past 4-6 weeks as per dermatologists’ discretion.

排除标准

•Subjects with other known skin condition that may impact the assessment.
•Subjects with any active infectious condition (eg.
•Herpes labialis).
•Subjects known to have bleeding and clotting disorders (self-dec
•Subjects known to have connective tissue disorders.

结局指标

主要结局

Change in mMASI score in comparison to baseline

时间窗: baseline, weeks 2, 4, 6, 8 and 12

次要结局

Incidence of adverse events (AE), adverse device effects (ADE), serious adverse events (SAE), and serious adverse device effects (SADE), and device deficiency (DD) throughout the clinical investigation.(baseline, weeks 2, 4, 6, 8 and 12)

研究者

发起方

Equipmed USA LLC.

申办方类型

Other [Medical Device Company]

研究点 (1)

Loading locations...

相似试验

尚未招募

Phase 3 4

Study comparing Platelet Rich Plasma with THBG in patients of melasma

CTRI/2019/07/020435Government medical college bhavnagar60

已完成

不适用

A Clinical Observation of 1064-nm Q-Switched Fractional Laser Combined With Oral Tranexamic Acid on Treating of Melasma.Melasma

NCT03963466xjpfW30

已完成

3 期

Comparing efficacy of different preparations of Tranexamic Acid in the management of melasma

CTRI/2023/10/058614Ashutosh Trivedi96

尚未招募

4 期

To know the bettertreatment for melasma skin disease intralesional tranexamic acid or glycolic acid chemical peel

CTRI/2023/09/057178Madeshwari M40

尚未招募

3 期

Kantikara Lepa in Mukha Vaivarnya (Sun Tan)

CTRI/2020/05/025054Sri Sri College Of Ayurvedic Science And Research40