NCT03899233

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

Comparing Tranexamic Acid Microinjection Alone Versus Its Combination With Fractional Carbon Dioxide Laser in Melasma Treatment

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melasma

Interventions

Type	Name	Description
DEVICE	Fractional CO2 laser	Low power fractional CO2 laser with a power of 12 watts, spacing 800 micrometer (7.3% density), and dwell time 300 microsecond
DRUG	Tranexamic acid intradermal microinjections	Tranexamic acid 500mg/5ml ampules

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-10-01
• Completion: 2019-11-01
• First posted: 2019-04-02
• Last updated: 2019-04-02