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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

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.

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.

Eligibility

Primary outcome measure(s)

• Change in Melasma Area and Severity Index (MASI) Score — Baseline to 3 months after the final treatment session (approximately 5 months after randomization)
  MASI score mean difference before minus after will be calculated to detect the highest change or improvement
• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] — Baseline to 3 months after the final treatment session (approximately 5 months after randomization)
  the adverse effects associated with each treatment

Trial sites (1)

Other trials for the same condition