Evaluation of Laser and Tranexamic Acid in Treatment of Melasma

NCT ID: NCT04599205

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-31
• Study Completion Date: 2022-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: DRUG

fractional co2 laser, microneedling and topical tranexamic acid gel

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.

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: DRUG

fractional co2 laser, microneedling and topical tranexamic acid gel

Gel group C

patients will be subjected to: Daily application of topical TXA gel (2 finger units) on both face sides.

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: DRUG

fractional co2 laser, microneedling and topical tranexamic acid gel

Interventions

Tranexamic acid

fractional co2 laser, microneedling and topical tranexamic acid gel

Intervention Type: DRUG

Other Intervention Names

laser; microneedling

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Aya Hasan

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

EMAN R MOHAMED, MD

Role: STUDY_DIRECTOR

assuit university hospital

Central Contacts

aya H younis, MD

Role: CONTACT

aya.h@yahoo.com

00201098898917

Other Identifiers

EOFCLATAITOMCHAIS

Identifier Type: -

Identifier Source: org_study_id