NCT04599205

Evaluation of Laser and Tranexamic Acid in Treatment of Melasma

Evaluation of Fractional CO2 Laser and Tranexamic Acid in Treatment of Melasma:Clinical,Histopathological and Immunohistochemical Study

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Melasma Is an acquired, chronic, recurrent, symmetrical hypermelanosis, which is characterized by brown patches of variable darkness on sun exposed areas of the body. It is more common in women. It is common psychologically and emotionally distressing cosmetic problem in affected patients .

Detailed description

Many studies examined multiple treatment options for melasma , but none of them is completely satisfactory with recurrence in most cases. Tranexamic acid is is a relatively new drug for melasma . It is currently used via a spectrum of delivery routes including oral, topical, intradermal, and microneedling . Laser-assisted drug delivery (LADD) is a technique that facilitates the delivery of topical medications . On reviewing the previous literatures, few studies have focused on therapeutic effects of combined laser and TXA (topical and intradermal) in melasma, with variations in parameters of laser, in dose, concentration, form and routes of TXA application; and in follow up duration. These studies revealed variable unproven results, and since melasma is a challenging disease, additional studies are needed to determine the optimal laser parameters and the best absorbable topical TXA formula, ensuring the best efficacy and less complications. To the best of our knowledge, this is the first study that will use topical TXA gel as an additive effect between sessions, and to confirm the effect of laser and TXA by histopathology and immunohistochemistry.

Conditions

• Melasma

Interventions

Type	Name	Description
DRUG	Tranexamic acid	fractional co2 laser, microneedling and topical tranexamic acid gel

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2020-10-22
• Last updated: 2020-10-22