Evaluation of Laser and Tranexamic Acid in Treatment of Melasma

Melasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04599205
• Other study ID #: EOFCLATAITOMCHAIS
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: December 2020
• Est. completion date: December 2022

Study information

• Verified date: October 2020
• Source: Assiut University
• Contact: aya H younis, MD
• Phone: 00201098898917
• Email: aya.h[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• - Gender: Only female patients.
• Age: 18-50 years old.
• Type of melasma: Bilateral symmetrical facial melasma of all types.
• Fitzpatrick skin phototypes: Types III, IV and V.

Exclusion Criteria:

• - Pregnancy and lactation.
• Patients taking oral contraceptive pills, hormonal replacement therapy or isotretinoin at the time of the study or during the past 6 months. Concomitant use of anticoagulants, bleeding disorders.
• Scarring and keloid tendency, active skin infections, active HSV, and those with facial cancer.
• History of photosensitivity or photosensitizing medications such as sulfonamides and tetracycline.
• Previous history of post inflammatory hyperpigmentation.

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Drug:
• Tranexamic acid
fractional co2 laser, microneedling and topical tranexamic acid gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and effectiveness of fractional CO2 laser, microneedling and topical tranexamic acid gel	the therapeutic effect of combined fractional co2 laser and topical tranexamic acid versus either fractional co2 laser alone, topical TXA alone or combined microneedling and TXA in treatment of melasma.this will be assessed by melasma area and severity index (MASI).	2 years
Secondary	accurate outcome of each treatment modality	every modality's effect will be measured by the histopathological changes by use of fontana asson stain.	2 years