Microneedling-Assisted Metformin, Tranexamic Acid, and Modified Kligman's Formula for Melasma
Enrolling by invitation · Phase 4
Conditions studied: Melasma (Facial Melasma)
In brief
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.
Key facts
- Study ID
- NCT07696806
- Run by
- Sameh Sarsik
- People needed
- 80
- Starts
- 2026-07-10
- Expected to finish
- 2027-08-30
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
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.
Where it is running
- Faculty of Medicine — Tanta, Egypt
Full record on ClinicalTrials.gov
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