| Registry | NCT07604844 |
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| Status | Not yet recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; non randomized, parallel, masking: single, treatment |
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| Enrollment | 120 (Estimated) |
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| Sponsor | Combined Military Hospital Abbottabad (Other) |
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| Conditions | Melasma |
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| Interventions | Mandelic Acid Peel, Intralesional Tranexamic Acid (Procedure) |
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| Dates | start 2026-05-01 (estimated), primary completion 2026-08-01 (estimated), completion 2026-10-01 (estimated), first posted 2026-05-22, last updated 2026-05-28 |
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| Locations | 1 site in Pakistan |
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Related Papers Related Patents Related Grants Related Experts
All trials for Melasma All trials of Mandelic Acid Peel All trials of Intralesional Tranexamic Acid
-Summary
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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+Detailed 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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Mandelic Acid Peel | Active comparator | Procedure: Mandelic Acid Peel | Participants will receive mandelic acid chemical peels every two weeks for six sessions over 12 weeks. |
| Intralesional Tranexamic Acid | Active comparator | Procedure: Intralesional Tranexamic Acid | Participants will receive intradermal tranexamic acid injections every two weeks for six sessions over 12 weeks. |
- 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.
+Outcome measures
Primary outcomes
- Proportion of participants achieving a Physician Global Assessment rating of good or excellent. [12 weeks]: Good response is defined as ≥51% improvement and excellent response as ≥76% improvement in pigmentation.
Secondary outcomes
- Change in modified Melasma Area and Severity Index(0-24), 0-clear, 24-severe [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 . [Baseline to 12 weeks]
- Patient satisfaction score (Likert Scale 1-5, 1:Very Dissatisfied, 5: Satisfied) [12 weeks]
- Frequency of treatment-related adverse events [Throughout the 12-week treatment period]
+Eligibility
Sex: All, ages: 18 Years to 45 Years
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.
+Locations (1)
| Facility | City | Country | Status |
|---|
| Combined Military Hospital, Abbottabad | Abbottabad, KPK | Pakistan | |
+Publications
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- Nagalakshmi S, Sriram G, Balachandar K, Dhayanithi D. A comparative evaluation of mandibular incisor decrowding with coaxial and optiflex arch wires and their load-deflection rates. J Pharm Bioallied Sci. 2014 Jul;6(Suppl 1):S118-21. doi: 10.4103/0975-7406.137412. PMID 25210351
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+Investigators