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

25 juli 2026 bijgewerkt door: Sameh Sarsik

Microneedling-Assisted Delivery of Metformin, Tranexamic Acid, and Modified Kligman's Formula for Melasma Treatment: A Clinical and Microscopic Evaluation

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.

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Egypte
      • Tanta, Egypte
        • Faculty of Medicine

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Microneedling + Topical Metformin
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.
Geneesmiddel: 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.
Experimenteel: Microneedling + Topical Tranexamic Acid
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.
Geneesmiddel: 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.
Experimenteel: Microneedling + Modified Kligman's Formula
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.
Geneesmiddel: 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.
Experimenteel: Microneedling + Saline
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.
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Melasma Area and Severity Index (MASI) Score
Tijdsspanne: 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
Baseline to 3 months after the final treatment session (approximately 5 months after randomization)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Tijdsspanne: Baseline to 3 months after the final treatment session (approximately 5 months after randomization)
the adverse effects associated with each treatment
Baseline to 3 months after the final treatment session (approximately 5 months after randomization)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sameh Sarsik

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

10 juli 2026

Primaire voltooiing (Geschat)

30 juni 2027

Studie voltooiing (Geschat)

30 augustus 2027

Studieregistratiedata

Eerst ingediend

6 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 juli 2026

Eerst geplaatst (Werkelijk)

10 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

25 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TU-DERM-MEL-2020-001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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