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A Study Comparing Two Skin-Needling Treatments for Reducing Dark Facial Patches (Melasma)

A COMPARATIVE EVALUATION OF THE EFFICACY OF MICRONEEDLING WITH TOPICAL METFORMIN SOLUTION AND MICRONEEDLING WITH TOPICAL TRANEXAMIC ACID SOLUTION IN THE TREATMENT OF MELASMA. - Nil

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/0103207
Enrollment
35
Registered
2026-02-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L814- Other melanin hyperpigmentation

Interventions

Intervention1: Metformin: Microneedling will be performed after topical application of freshly prepared 10% Metformin solution over the left-sided facial melasma lesions Intervention2: Tranexamic acid

Sponsors

Dr. Saravanan. P
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients who are clinically diagnosed as case of facial Melasma epidermal, dermal and mixed type. Patients who haven t received any treatment for past 3 months for recurrent melasma. Patients who give consent for treatment, clinical photography and follow up.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of allergy or prior oral treatment with metformin, tranexamic acid and oral isotretinoin within past 6 months. 2. Patients with active infection, premalignant or malignant lesions in the treatment area. 3. Pregnancy and lactating mothers. 4. Patients on active hormonal therapy or antioxidants in the last months. Patients using drugs causing photosensitivity or hyperpigmentation. 6. Patients with viral hepatitis B or C or HIV infection. 7. Patients with chronic diseases such as coagulation disorder, type 2 diabetes mellitus and hypertension. 8. Patients with history of hypertrophic scars or keloids.

Design outcomes

Primary

MeasureTime frame
1. Hemi-MASI score7 for each side of face measured at baseline and monthly up to 6 months. 2. Physician global assessment (PGA) and patient global assessment (PGA): 3. Patient satisfaction measured by a 10-cm Visual Analog Scale:Timepoint: 6 months

Secondary

MeasureTime frame
Standardized de-identified clinical photography at each visit (frontal, left and right 45 ).Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Saravanan N

Government Stanley Medical College and Hospital

saransundar@gmail.com9444500333

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026