drugset / Trial / NCT03899233

Tranexamic Acid vs. Combination With Fractional Carbon Dioxide Laser in Melasma

NCT03899233

Phase 4 Unknown 25 enrolled Cairo University
RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this study is to assess and compare the efficacy of tranexamic acid intradermal microinjection alone versus its combination with low power fractional CO2 laser in a sequential pattern. In all participants one half of the face will be randomly assigned to low power fractional CO2 laser while other side to Tranexamic acid intradermal microinjections on the 1st session. This split face session will be repeated every six weeks for 3 sessions. In addition, Tranexamic acid intradermal microinjections will be applied for full face at the 2nd and 4th week of each split face session. The response will be evaluated by the Melanin and erythema Indices which will be measured using reflectance spectrophotometer, Dermoscopy and photography before starting the study, two and four weeks after the last session. The sessions will take 4 months for each patient and another one month free of sessions for follow up.

Timeline

Start
2019-04-01
Primary completion
2019-10-01
Completion
2019-11-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tranexamic Acid Small molecule 100 mg Other