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

NCT07696806 | Enrolling By Invitation Phase 4 DMC

• 1 other identifier: TU-DERM-MEL-2020-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Melasma; Microneedling; Metformin; Tranexamic Acid; Modified Kligman's Formula; Hydroquinone

Outcome Measures

Primary Outcomes (2)

• Change in Melasma Area and Severity Index (MASI) Score

  MASI score mean difference before minus after will be calculated to detect the highest change or improvement

  Baseline to 3 months after the final treatment session (approximately 5 months after randomization)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  the adverse effects associated with each treatment

  Baseline to 3 months after the final treatment session (approximately 5 months after randomization)

Study Arms (4)

Microneedling + Topical Metformin

EXPERIMENTAL

Participants underwent standardized microneedling using a dermapen followed by topical application of 3 mL of 30% metformin lotion during each treatment session. Five treatment sessions were performed at 2-week intervals.

Drug: Metformin 30% Topical Lotion

Microneedling + Topical Tranexamic Acid

EXPERIMENTAL

Participants underwent standardized microneedling using a dermapen followed by topical application of 3 mL of 0.5% tranexamic acid solution during each treatment session. Five treatment sessions were performed at 2-week intervals.

Drug: Tranexamic Acid 0.5% Topical Solution

Microneedling + Modified Kligman's Formula

EXPERIMENTAL

Participants underwent standardized microneedling using a dermapen followed by topical application of modified Kligman's formula (hydroquinone 4%, tretinoin 0.05%, and mometasone furoate 0.1%) during each treatment session. Five treatment sessions were performed at 2-week intervals.

Drug: Modified Kligman's Formula

Microneedling + Saline

EXPERIMENTAL

Participants underwent standardized microneedling using a dermapen followed by topical application of 3 mL of normal saline during each treatment session. Five treatment sessions were performed at 2-week intervals.

Drug: Normal Saline

Interventions

Metformin 30% Topical Lotion DRUG

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.

Microneedling + Topical Metformin

Tranexamic Acid 0.5% Topical Solution DRUG

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.

Microneedling + Topical Tranexamic Acid

Modified Kligman's Formula DRUG

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.

Microneedling + Modified Kligman's Formula

Normal Saline DRUG

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.

Microneedling + Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants aged 18 years or older.
• Clinical diagnosis of melasma.
• No medical treatment for melasma during the previous 6 months.
• Willing and able to comply with all study procedures and follow-up visits.
• Provided written informed consent before study participation.

You may not qualify if:

• Pregnant or breastfeeding women.
• Use of hormonal contraceptives.
• Use of medications known to affect skin pigmentation (e.g., phenytoin, amiodarone, antipsychotics, cytotoxic agents, tetracyclines, or heavy metals).
• History of keloid formation or foreign body reaction.
• Known allergy or hypersensitivity to any study medication.
• Presence of systemic diseases affecting pigmentation, including hepatic, renal, thyroid, or other endocrine disorders.
• Fitzpatrick skin types V or VI.

Sponsors & Collaborators

• Sameh Sarsik: lead

Study Sites (1)

Faculty of Medicine

Tanta, Egypt

Location

MeSH Terms

Conditions

Melanosis

Interventions

Metformin; Tranexamic Acid; Solutions; Saline Solution

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Model Details: Participants were randomly assigned in a 1:1:1:1 ratio to one of four parallel treatment groups. All participants underwent standardized microneedling with a dermapen before receiving the assigned topical intervention: 30% metformin lotion, 0.5% tranexamic acid solution, modified Kligman's formula, or saline (control). Treatment consisted of five sessions performed at 2-week intervals, followed by a 3-month follow-up period to evaluate efficacy and safety.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)