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NCT Number: NCT07604844

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Combined Military Hospital, Abbottabad

Abbottabad, KPK, 22010, Pakistan

Location contact

Ali Amar, MBBS, FCPS(Dermatology), CHPE

CONTACT

[email protected]

+923215625426

Shapara Shakeel, MBBS, FCPS-resident derm

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mandelic Acid Peel

Procedure

After degreasing the face, mandelic acid solution will be applied for 5-7 minutes and then neutralized. Sessions will be repeated every two weeks for six sessions.

Intralesional Tranexamic Acid

Procedure

Tranexamic acid will be injected intradermally at 1-cm intervals over melasma patches using a 30-gauge insulin syringe every two weeks for six sessions.

Primary outcomes

  1. Proportion of participants achieving a Physician Global Assessment rating of good or excellent.

    Time frame: 12 weeks

    Good response is defined as ≥51% improvement and excellent response as ≥76% improvement in pigmentation.

Secondary outcomes

  1. Change in modified Melasma Area and Severity Index(0-24), 0-clear, 24-severe

    Time frame: Baseline to 12 weeks

  2. Change in Melasma Quality of Life Scale MELASQoL score(7-70) 10 - 39: Mild quality of life impairment, 40 - 54: Moderate quality of life impairment, 55 - 70: Severe quality of life impairment .

    Time frame: Baseline to 12 weeks

  3. Patient satisfaction score (Likert Scale 1-5, 1:Very Dissatisfied, 5: Satisfied)

    Time frame: 12 weeks

  4. Frequency of treatment-related adverse events

    Time frame: Throughout the 12-week treatment period

Study contacts

Contact information is provided by the study sponsor or research team.

Ovais Faizi, MBBS, FCPS(Internal Medicine)

CONTACT

[email protected]

+923134422922

Shapara Shakeel, MBBS, FCPS-resident derm

CONTACT

[email protected]

+923489081830

Sponsors and collaborators

Lead sponsor

Combined Military Hospital Abbottabad

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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