Melasma
Conditions
Keywords
Melasma, Tranexamic Acid, Mandelic Acid, Chemical Peel, Hyperpigmentation, MELASQoL, Pakistan
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.
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
PROCEDUREMandelic 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.
PROCEDUREIntralesional 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.
Sponsors
Combined Military Hospital Abbottabad
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessments will be performed by a blinded investigator.
Intervention model description
Participants will be assigned alternately to one of two treatment groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving a Physician Global Assessment rating of good or excellent. | 12 weeks | Good response is defined as ≥51% improvement and excellent response as ≥76% improvement in pigmentation. |
Secondary
| Measure | 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 . | 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 |
Countries
Pakistan
Contacts
CONTACTShapara Shakeel, MBBS, FCPS-resident derm
CONTACTOvais Faizi, MBBS, FCPS(Internal Medicine)
STUDY_CHAIRAli Amar, MBBS, FCPS(dermatology), CHPE
Combined Military Hospital Abbottabad
Outcome results
None listed