A study to check whether Dermapen 4™ microneedling device with MG-BL serum reduces melasma

Phase 2

Not yet recruiting

• Conditions: Subjects with mild and moderate melasma.

• Registration Number: CTRI/2025/04/083956
• Lead Sponsor: Equipmed USA LLC.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-02-04
• Study Start: 2025-04-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 55

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 4.
• Subjects known to have connective tissue disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mMASI score in comparison to baseline	baseline, weeks 2, 4, 6, 8 and 12

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

MS Clinical Research Pvt. Ltd,; 🇮🇳 Bangalore, KARNATAKA, India

MS Clinical Research Pvt. Ltd,

🇮🇳Bangalore, KARNATAKA, India

Dr Mukta Sachdev

Principal investigator

08040917253

mukta.sachdev@msclinical.com