Combined Military Hospital, Abbottabad
Abbottabad, KPK, 22010, Pakistan
Location contact
Ali Amar, MBBS, FCPS(Dermatology), CHPE
CONTACT
Shapara Shakeel, MBBS, FCPS-resident derm
PRINCIPAL_INVESTIGATOR
CONTACT
NCT Number: NCT07604844
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 opening soon.
Get Notified18 year–45 year
All sexes
Interventional
Not applicable
Abbottabad, KPK, 22010, Pakistan
Ali Amar, MBBS, FCPS(Dermatology), CHPE
CONTACT
Shapara Shakeel, MBBS, FCPS-resident derm
PRINCIPAL_INVESTIGATOR
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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.
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.
Time frame: 12 weeks
Good response is defined as ≥51% improvement and excellent response as ≥76% improvement in pigmentation.
Time frame: Baseline to 12 weeks
Time frame: Baseline to 12 weeks
Time frame: 12 weeks
Time frame: Throughout the 12-week treatment period
Contact information is provided by the study sponsor or research team.
Ovais Faizi, MBBS, FCPS(Internal Medicine)
CONTACT
Shapara Shakeel, MBBS, FCPS-resident derm
CONTACT
Combined Military Hospital Abbottabad
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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