Comparative Efficacy of Intralesional Tranexamic Acid Versus Mandelic Acid Peel in the Treatment of Melasma

ConditionMelasma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorCombined Military Hospital Abbottabad

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mandelic Acid Peel

    Procedure/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 Acid

    Procedure/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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Mandelic Acid PeelActive comparator 1 intervention
Group B: Intralesional Tranexamic AcidActive comparator 1 intervention

Trial outcomes

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.

Time frame
12 weeks

Secondary outcomes

1

Change in modified Melasma Area and Severity Index(0-24), 0-clear, 24-severe

Time frame
Baseline to 12 weeks
2

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
3

Patient satisfaction score (Likert Scale 1-5, 1:Very Dissatisfied, 5: Satisfied)

Time frame
12 weeks
4

Frequency of treatment-related adverse events

Time frame
Throughout the 12-week treatment period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: