NCT07604844

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
May 2026Oct 2026

Study Start

First participant enrolled

May 1, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 17, 2026

Last Update Submit

May 17, 2026

Conditions

Melasma

Keywords

MelasmaTranexamic AcidMandelic AcidChemical PeelHyperpigmentationMELASQoLPakistan

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Change in modified Melasma Area and Severity Index (mMASI)

    Baseline to 12 weeks

  • Change in MELASQoL score

    Baseline to 12 weeks

  • Patient satisfaction score

    12 weeks

  • Frequency of treatment-related adverse events

    Throughout the 12-week treatment period

Study Arms (2)

Mandelic Acid Peel

ACTIVE COMPARATOR

Participants will receive mandelic acid chemical peels every two weeks for six sessions over 12 weeks.

Procedure: Mandelic Acid Peel

Intralesional Tranexamic Acid

ACTIVE COMPARATOR

Participants will receive intradermal tranexamic acid injections every two weeks for six sessions over 12 weeks.

Procedure: Intralesional Tranexamic Acid

Interventions

Mandelic Acid PeelPROCEDURE

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.

Mandelic Acid Peel
Intralesional Tranexamic AcidPROCEDURE

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.

Intralesional Tranexamic Acid

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-45 years. Clinical diagnosis of facial melasma. Fitzpatrick skin phototypes III-V. Disease duration of at least 3 months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Combined Military Hospital, Abbottabad

Abbottabad, KPK, 22010, Pakistan

Location

Related Publications (8)

  • 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.

    PMID: 31576141BACKGROUND

  • 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.

    PMID: 28691210BACKGROUND

  • 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: 25830989BACKGROUND

  • 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.

    PMID: 19708933BACKGROUND

  • 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.

    PMID: 25396104BACKGROUND

  • 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.

    PMID: 29492982BACKGROUND

  • 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: 25210351BACKGROUND

  • 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: 28726212BACKGROUND

MeSH Terms

Conditions

MelanosisHyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ali Amar, MBBS, FCPS(dermatology), CHPE

    Combined Military Hospital Abbottabad

    STUDY CHAIR

Central Study Contacts

Shapara Shakeel, MBBS, FCPS-resident derm

CONTACT

+923489081830shaparashakil@gmail.com

Ovais Faizi, MBBS, FCPS(Internal Medicine)

CONTACT

+923134422922ovaisfaizi@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessments will be performed by a blinded investigator.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned alternately to one of two treatment groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Dermatologist

Study Record Dates

First Submitted

May 17, 2026

First Posted

May 22, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made publicly available.

Locations

PA(1)