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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/083956

Enrollment

Registered

2025-04-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Dermapen 4 microneedling device in conjunction with MG-BL serum.: Treatment using Dermapen 4 microneedling device in conjunction with MG-BL serum will be provided at baseline, week 2,

Eligibility

Inclusion criteria

Inclusion criteria: 1. Fitzpatrick skin phototype III to VI. 2. Subjects presenting with moderate facial Melasma. 3. 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

Exclusion criteria: 1. Subjects with other known skin condition that may impact the assessment. 2. Subjects with any active infectious condition (eg. Herpes labialis). 3. Subjects known to have bleeding and clotting disorders (self-dec 4. Subjects known to have connective tissue disorders.

Design outcomes

Primary

Measure	Time frame
Change in mMASI score in comparison to baselineTimepoint: baseline, weeks 2, 4, 6, 8 and 12	—

Secondary

Measure	Time frame
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.Timepoint: baseline, weeks 2, 4, 6, 8 and 12	—

Countries

India

Contacts

Public ContactSudhanthiran S

MS Clinical Research Pvt. Ltd.

ritambhara@msclinical.com8040917253

Outcome results