Comparative Efficacy of Intralesional Tranexamic Acid Versus Mandelic Acid Peel in the Treatment of Melasma

Combined Military Hospital Abbottabad

Status: Not yet enrolling

Conditions: Melasma

Treatments: Procedure: Intralesional Tranexamic Acid; Procedure: Mandelic Acid Peel

Study type: Interventional

Funder types: Other

Identifiers

NCT07604844

CMH-Atd-ETH-242-Derma-2026

Details and patient eligibility

About

Melasma is a chronic acquired disorder of facial hyperpigmentation that significantly affects quality of life. Both intralesional tranexamic acid and mandelic acid chemical peels are effective treatment options with favorable safety profiles in darker skin types. However, comparative evidence in South Asian populations is limited. This study aims to compare the efficacy, safety, quality of life outcomes, and patient satisfaction of intralesional tranexamic acid versus mandelic acid peel in patients with facial melasma treated at Combined Military Hospital Abbottabad.

Full description

This quasi-experimental, non-randomized controlled trial will be conducted in the Department of Dermatology, Combined Military Hospital Abbottabad. A total of 120 patients aged 18-45 years with clinically diagnosed facial melasma will be enrolled and allocated alternately into two groups. Group A will receive mandelic acid chemical peels every two weeks for six sessions. Group B will receive intradermal tranexamic acid injections every two weeks for six sessions. All participants will receive sunscreen and photoprotection counseling. Outcomes will be assessed using Physician Global Assessment, modified Melasma Area and Severity Index (mMASI), MELASQoL questionnaire, adverse event monitoring, and patient satisfaction over a 12-week period.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Age 18-45 years. Clinical diagnosis of facial melasma. Fitzpatrick skin phototypes III-V. Disease duration of at least 3 months.

Exclusion criteria

Pregnancy or lactation. Known hypersensitivity to tranexamic acid or mandelic acid. Active facial dermatoses or infection. Personal or family history of thromboembolic disease. Coagulation disorders. Systemic retinoid use within 6 months. Oral contraceptive or hormone replacement therapy within 6 months. Use of topical or systemic depigmenting agents within 4 weeks. History of keloid tendency.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Mandelic Acid Peel

Active Comparator group

Description:

Participants will receive mandelic acid chemical peels every two weeks for six sessions over 12 weeks.

Treatment:

Procedure: Mandelic Acid Peel

Intralesional Tranexamic Acid

Active Comparator group

Description:

Participants will receive intradermal tranexamic acid injections every two weeks for six sessions over 12 weeks.

Treatment:

Procedure: Intralesional Tranexamic Acid