Comparative Efficacy of Intralesional Tranexamic Acid Versus Mandelic Acid Peel in the Treatment of Melasma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mandelic Acid Peel, Intralesional Tranexamic Acid.
- Who it may be relevant to
- Registry conditions: Melasma. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- Procedure Mandelic Acid Peel
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. - Procedure Intralesional Tranexamic Acid
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 outcome measures
- Proportion of participants achieving a Physician Global Assessment rating of good or excellent. [Time frame: 12 weeks]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Combined Military Hospital, Abbottabad — Abbottabad
Publications
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- Ikino JK, Nunes DH, Silva VP, Frode TS, Sens MM. Melasma and assessment of the quality of life in Brazilian women. An Bras Dermatol. 2015 Mar-Apr;90(2):196-200. doi: 10.1590/abd1806-4841.20152771. PMID 25830989
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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
- Ogbechie-Godec OA, Elbuluk N. Melasma: an Up-to-Date Comprehensive Review. Dermatol Ther (Heidelb). 2017 Sep;7(3):305-318. doi: 10.1007/s13555-017-0194-1. Epub 2017 Jul 19. PMID 28726212
Identifiers
NCT: NCT07604844 · CMH-Atd-ETH-242-Derma-2026