An interventional study of Mandelic Acid Peel and Intralesional Tranexamic Acid in Melasma, sponsored by Combined Military Hospital Abbottabad. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Combined Military Hospital Abbottabad · Not applicable, Interventional, and Treatment
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.
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.
170 studies on the registry are indexed under Melanosis; 46 are open to participants now.
This study's planned enrollment of 120 is above the median of 40 across 157 interventional studies indexed under Melanosis.
Browse Melanosis studies →Combined Military Hospital Abbottabad is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
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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 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 or hormone replacement therapy within 6 months. Use of topical or systemic depigmenting agents within 4 weeks. History of keloid tendency.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive mandelic acid chemical peels every two weeks for six sessions over 12 weeks.
Procedure: Mandelic Acid Peel
Participants will receive intradermal tranexamic acid injections every two weeks for six sessions over 12 weeks.
Procedure: Intralesional Tranexamic Acid
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.
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.
Proportion of participants achieving a Physician Global Assessment rating of good or excellent.
Good response is defined as ≥51% improvement and excellent response as ≥76% improvement in pigmentation.
Time frame: 12 weeks
Change in modified Melasma Area and Severity Index(0-24), 0-clear, 24-severe
Time frame: Baseline to 12 weeks
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
Patient satisfaction score (Likert Scale 1-5, 1:Very Dissatisfied, 5: Satisfied)
Time frame: 12 weeks
Frequency of treatment-related adverse events
Time frame: Throughout the 12-week treatment period
Plan to share: No — Individual participant data will not be made publicly available.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Combined Military Hospital Abbottabad