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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mandelic Acid Peel | Active Comparator | Participants will receive mandelic acid chemical peels every two weeks for six sessions over 12 weeks. |
|
| Intralesional Tranexamic Acid | Active Comparator | Participants will receive intradermal tranexamic acid injections every two weeks for six sessions over 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 . |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shapara Shakeel, MBBS, FCPS-resident derm | Contact | +923489081830 | shaparashakil@gmail.com | |
| Ovais Faizi, MBBS, FCPS(Internal Medicine) | Contact | +923134422922 | ovaisfaizi@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Ali Amar, MBBS, FCPS(dermatology), CHPE | Combined Military Hospital Abbottabad | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Combined Military Hospital, Abbottabad | Abbottabad | KPK | 22010 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31576141 | Background | Xu L, Ding X, Ying L, Zhang X, Lu N. Follicular Lymphoma Presenting With Monoclonal IgM And MYD88 Mutation: A Case Report And Review Of The Literature. Onco Targets Ther. 2019 Sep 23;12:7833-7842. doi: 10.2147/OTT.S211436. eCollection 2019. | |
| 28691210 | Background | Tong M, Kotur T, Liang W, Vogelmann K, Kleine T, Leister D, Brieske C, Yang S, Ludke D, Wiermer M, Zhang Y, Li X, Hoth S. E3 ligase SAUL1 serves as a positive regulator of PAMP-triggered immunity and its homeostasis is monitored by immune receptor SOC3. New Phytol. 2017 Sep;215(4):1516-1532. doi: 10.1111/nph.14678. Epub 2017 Jul 10. |
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Individual participant data will not be made publicly available.
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| ID | Term |
|---|---|
| D008548 | Melanosis |
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Participants will be assigned alternately to one of two treatment groups.
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Outcome assessments will be performed by a blinded investigator.
| 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. |
|
| 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 |
| 25830989 | Background | 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. |
| 19708933 | Background | Slovacek L, Slovackova B, Slanska I, Hrstka Z, Priester P. Incidence and relevance of depression among palliative care female inpatients. Eur J Cancer Care (Engl). 2010 Sep;19(5):e8-9. doi: 10.1111/j.1365-2354.2008.01030.x. Epub 2009 Aug 25. No abstract available. |
| 25396104 | Background | Sedighi M, Haghnegahdar A. Lumbar disk herniation surgery: outcome and predictors. Global Spine J. 2014 Dec;4(4):233-44. doi: 10.1055/s-0034-1390010. Epub 2014 Sep 26. |
| 29492982 | Background | Marsidi N, Beijnen JH, van Zuuren EJ. Palladium-induced granulomas analysed with inductively coupled plasma mass spectrometry. Contact Dermatitis. 2018 Jul;79(1):41-42. doi: 10.1111/cod.12979. Epub 2018 Mar 1. No abstract available. |
| 25210351 | Background | 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. |
| 28726212 | Background | 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. |