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Microneedling-Assisted Metformin, Tranexamic Acid, and Modified Kligman's Formula for Melasma

NCT07696806 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-07-28

No results posted yet for this study

Summary

Melasma is a common skin condition characterized by brown or gray patches on sun-exposed areas of the face. Although several topical treatments are available, treatment outcomes are often unsatisfactory, and recurrence is common. This randomized, parallel-group clinical trial aims to compare the efficacy and safety of microneedling-assisted topical metformin, topical tranexamic acid, and modified Kligman's formula with microneedling-assisted saline in adult women with melasma. Eighty participants will be randomly assigned to one of four treatment groups. The primary outcome is the change in Melasma Area and Severity Index (MASI) score from baseline to the end of follow-up. Secondary outcomes include clinical improvement, dermoscopic changes in pigmentation and vascular features, patient satisfaction, and treatment-related adverse events.

Conditions

  • Melasma (Facial Melasma)

Interventions

DRUG

Metformin 30% Topical Lotion

Participants received topical metformin 30% lotion immediately after standardized microneedling with a dermapen. Approximately 3 mL of the lotion was applied during each treatment session. Five treatment sessions were performed at 2-week intervals. Participants were instructed to leave the medication on the skin for 4 hours before washing.

DRUG

Tranexamic Acid 0.5% Topical Solution

Participants received topical tranexamic acid 0.5% solution immediately after standardized microneedling with a dermapen. Approximately 3 mL of the solution was applied during each treatment session. Five treatment sessions were performed at 2-week intervals. Participants were instructed to leave the medication on the skin for 4 hours before washing.

DRUG

Modified Kligman's Formula

Participants received modified Kligman's formula consisting of hydroquinone 4%, tretinoin 0.05%, and mometasone furoate 0.1% immediately after standardized microneedling with a dermapen. Approximately 3 mL was applied during each treatment session. Five treatment sessions were performed at 2-week intervals. Participants were instructed to leave the medication on the skin for 4 hours before washing.

DRUG

Normal Saline

Participants received topical normal saline immediately after standardized microneedling with a dermapen. Approximately 3 mL of saline was applied during each treatment session. Five treatment sessions were performed at 2-week intervals. Participants were instructed to leave the saline on the skin for 4 hours before washing.

Sponsors & Collaborators

  • Sameh Sarsik

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-10
Primary Completion
2027-06-30
Completion
2027-08-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07696806 on ClinicalTrials.gov