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

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 .

Study Overview

• Status: Unknown
• Conditions: Melasma
• Intervention / Treatment: Drug: Tranexamic acid

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: aya H younis, MD; Phone Number: 00201098898917; Email: aya.h@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microneedling group A; Patients will be subjected to the following: Combined laser (power=3.6 mJ) and topical tranexamic acid (TXA) (one finger unit) gel on the right half of the face. Combined microneedling (by dermapen) and topical TXA gel only on the left half. Self application of topical TXA gel (2 finger units) on both sides on daily base.	Drug: Tranexamic acid; fractional co2 laser, microneedling and topical tranexamic acid gel; Other Names: laser; microneedling
Experimental: Laser group B; Patients will be subjected to the following: Combined laser(power=3.6 mJ) and topical TXA gel (one finger unit) on the right half. Laser (power=3.6 mJ) only on the left one.	Drug: Tranexamic acid; fractional co2 laser, microneedling and topical tranexamic acid gel; Other Names: laser; microneedling
Experimental: Gel group C; patients will be subjected to: Daily application of topical TXA gel (2 finger units) on both face sides.	Drug: Tranexamic acid; fractional co2 laser, microneedling and topical tranexamic acid gel; Other Names: laser; microneedling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: EMAN R MOHAMED, MD, Assuit University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: October 17, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 17, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: EOFCLATAITOMCHAIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No