MelasmaNCT07604844
Comparative Efficacy of Intralesional Tranexamic Acid Versus Mandelic Acid Peel in the Treatment of Melasma
A study testing Mandelic Acid Peel and Intralesional Tranexamic Acid in people with Melasma, run by Combined Military Hospital Abbottabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Melasma
- What is being tested?
- Mandelic Acid Peel and Intralesional Tranexamic Acid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- May 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-45 years. Clinical diagnosis of facial melasma. Fitzpatrick skin phototypes III-V. Disease duration of at least 3 months.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Combined Military Hospital, Abbottabad
Abbottabad, KPK, 22010
Ali Amar, MBBS, FCPS(Dermatology), CHPE, +923215625426, docaliamar@gmail.com
shaparashakil@gmail.com
About this study
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.
Read the 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.
- Conditions
- Melasma
- Being tested
- Mandelic Acid Peel, Intralesional Tranexamic Acid
- Keywords
- Melasma, Tranexamic Acid, Mandelic Acid, Chemical Peel, Hyperpigmentation, MELASQoL, Pakistan
- Medical subject headings
- Melanosis, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandelic Acid PeelProcedure or surgery
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 AcidProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Mandelic Acid Peel | Active comparator | Participants will receive mandelic acid chemical peels every two weeks for six sessions over 12 weeks. Receives: 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. Receives: Procedure: Intralesional Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
Change in modified Melasma Area and Severity Index(0-24), 0-clear, 24-severe
Measured: 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 .
Measured: Baseline to 12 weeks
Patient satisfaction score (Likert Scale 1-5, 1:Very Dissatisfied, 5: Satisfied)
Measured: 12 weeks
Frequency of treatment-related adverse events
Measured: Throughout the 12-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study startMay 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned alternately to one of two treatment groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital Abbottabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Shapara Shakeel, Combined Military Hospital Abbottabad
- Investigators
- Ali Amar, MBBS, FCPS(dermatology), CHPE, Study chair, Combined Military Hospital Abbottabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604844
- Sponsor's protocol ID
- CMH-Atd-ETH-242-Derma-2026
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available.
Publications
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.
PubMed 31576141Tong 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.
PubMed 28691210Ikino 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.
PubMed 25830989Slovacek 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.
PubMed 19708933Sedighi 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.
PubMed 25396104Marsidi 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.
PubMed 29492982Nagalakshmi 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.
PubMed 25210351Ogbechie-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.
PubMed 28726212
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Intralesional Tranexamic Acid Versus Mandelic Acid Peel in the Treatment of Melasma
- ClinicalTrials.gov ID
- NCT07604844
- Acronym / sponsor ID
- CMH-Atd-ETH-242-Derma-2026
- Conditions
- Melasma
- Keywords
- Melasma, Tranexamic Acid, Mandelic Acid, Chemical Peel, Hyperpigmentation, MELASQoL, Pakistan
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Combined Military Hospital AbbottabadUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned alternately to one of two treatment groups.
| Arm | Type | Receives |
|---|---|---|
| Mandelic Acid Peel | Active comparator | Procedure: Mandelic Acid PeelParticipants will receive mandelic acid chemical peels every two weeks for six sessions over 12 weeks. |
| Intralesional Tranexamic Acid | Active comparator | Procedure: Intralesional Tranexamic AcidParticipants will receive intradermal tranexamic acid injections every two weeks for six sessions over 12 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 18-45 years. Clinical diagnosis of facial melasma. Fitzpatrick skin phototypes III-V. Disease duration of at least 3 months.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandelic Acid PeelAfter 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 or surgery | Mandelic Acid Peel |
| Intralesional Tranexamic AcidTranexamic acid will be injected intradermally at 1-cm intervals over melasma patches using a 30-gauge insulin syringe every two weeks for six sessions. | Procedure or surgery | Intralesional Tranexamic Acid |
Primary outcome
Proportion of participants achieving a Physician Global Assessment rating of good or excellent.
Time frame: 12 weeks
Good response is defined as ≥51% improvement and excellent response as ≥76% improvement in pigmentation.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 31576141Xu 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.
- Background: PubMed 28691210Tong 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.
- Background: PubMed 25830989Ikino 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.
- Background: PubMed 19708933Slovacek 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.
- Background: PubMed 25396104Sedighi 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.
- Background: PubMed 29492982Marsidi 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.
- Background: PubMed 25210351Nagalakshmi 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.
- Background: PubMed 28726212Ogbechie-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.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali Amar, MBBS, FCPS(dermatology), CHPE study chair
Combined Military Hospital Abbottabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandelic Acid Peel and Intralesional Tranexamic Acid in people with Melasma, run by Combined Military Hospital Abbottabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shapara Shakeel, MBBS, FCPS-resident derm (+923489081830, shaparashakil@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving a Physician Global Assessment rating of good or excellent. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07604844, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.