A Phase 4 interventional study of Metformin 30% Topical Lotion and Tranexamic Acid 0.5% Topical Solution in Melasma (Facial Melasma), sponsored by Sameh Sarsik. Enrolling by invitation at 1 site in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Sameh Sarsik · Phase 4, Interventional, and Treatment
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.
Melasma is a chronic acquired hyperpigmentation disorder characterized by symmetric brown to gray-brown macules and patches affecting sun-exposed areas of the skin, particularly the face. It predominantly affects women of reproductive age and has a considerable negative impact on quality of life. The pathogenesis of melasma is multifactorial, involving genetic predisposition, ultraviolet radiation, hormonal influences, increased melanogenesis, vascular alterations, and inflammatory pathways. Despite the availability of multiple treatment options, recurrence is common and no universally effective therapy has been established.
Microneedling is a minimally invasive procedure that enhances transdermal drug delivery by creating controlled microchannels within the skin, thereby improving the penetration and bioavailability of topical agents. Topical metformin has recently emerged as a potential depigmenting agent through inhibition of melanogenesis and reduction of tyrosinase activity. Tranexamic acid inhibits ultraviolet-induced melanogenesis by suppressing the plasminogen-plasmin pathway and reducing melanocyte activation. Modified Kligman's formula, consisting of hydroquinone, tretinoin, and a topical corticosteroid, remains the standard topical treatment for melasma but is frequently associated with local adverse effects.
This prospective, randomized, parallel-group clinical trial was designed to compare the efficacy and safety of microneedling-assisted topical metformin, topical tranexamic acid, modified Kligman's formula, and saline as a control in women with melasma. Eighty eligible participants were randomly allocated in a 1:1:1:1 ratio to one of four treatment groups. All participants underwent standardized microneedling using a dermapen before application of the assigned topical treatment. Treatment sessions were performed every two weeks for a maximum of five sessions, followed by a three-month follow-up period.
The primary objective was to evaluate changes in the Melasma Area and Severity Index (MASI). Secondary objectives included assessment of clinical improvement, dermoscopic changes in pigmentation and vascular features, patient satisfaction, and treatment-related adverse events. The findings of this study are expected to provide comparative evidence regarding the effectiveness and safety of these microneedling-assisted topical therapies and help optimize treatment strategies for patients with melasma.
170 studies on the registry are indexed under Melanosis; 46 are open to participants now.
This study's planned enrollment of 80 is above the median of 40 across 157 interventional studies indexed under Melanosis.
Browse Melanosis studies →Sameh Sarsik is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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.
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.
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.
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.
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
Time frame: 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
Time frame: Baseline to 3 months after the final treatment session (approximately 5 months after randomization)
Plan to share: No
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Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.
Start moved once since we started tracking on Sep 25, 2026: Jul 2026 → Oct 2026, on Oct 27, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Metformin · Tranexamic Acid
Sameh Sarsik