Fractional Erbium YAG Laser vs Intradermal and Systemic Tranexamic Acid

NCT06522984 | Recruiting DMC

• 1 other identifier: Heba Allah Mohamed Mustafa
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Melasma is a common acquired disorder of hyperpigmentaion caused by increased melanin production by melanocytes. Melasma is a name derived from the Greek word melas meaning black.It is characterized by the appearance of brownish or grayish symmetrical patches on sun-exposed skin, most commonly on the face. Compared to men, women are more likely to be affected.

Conditions

Refractory Melasma

Outcome Measures

Primary Outcomes (1)

• Refractory Melasma Treatment combination with topical hydroquinone

  to detect the treatment response by YAG laser vs intradermal and systemic tranexamic acid by using The MASI index ( MASI is an index designed to quantify the severity of melasma during therapy).

  3 months

Study Arms (3)

Group A

ACTIVE COMPARATOR

About 15 cases will receive sessions with fractional Er: YAG laser every 3 weeks followed by application of topical 4% (HQ) cream.

Drug: Tranexamic acid injection

Group B

ACTIVE COMPARATOR

About 15 cases will receive sessions of intradermal injection of tranexamic acid on the melasma site every 3 weeks concurrently with the application of topical 4% HQ cream every night. The injections will be done using an insulin syringe with a dilution of the tranexamic acid

Drug: Tranexamic acid injection

Group C

ACTIVE COMPARATOR

About 15 cases will receive oral tranexamic acid 500mg tablet once daily for three months. And will also be asked to apply a thin layer of topical HQ 4% cream on the hyperpigmented areas once every night.

Drug: Tranexamic acid injection

Interventions

Tranexamic acid injection DRUG

to evaluate and compare efficacy of: * Fractional Er: YAG laser combined with topical hydroquinone. * Intradermal injection of tranexamic acid combined with topical hydroquinone cream. * Oral administration of tranexamic acid combined with topical hydroquinone cream. In treating refractory melasma.

Also known as: Fractional erbium YAG laser

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Patients of both sexes with melasma.

You may not qualify if:

• Pregnancy
• Lactation
• Administration of oral contraceptive pills or any phototoxic drug within 1 month prior to study
• Patients with a history of thrombosis, abnormal bleeding profile, known hypersensitivity to TA or HQ, and endocrinal disease.

Sponsors & Collaborators

• Egymedicalpedia: lead
• Aswan University: collaborator

Study Sites (1)

Aswan University hospitals

Aswān, Egypt

RECRUITING

MeSH Terms

Conditions

Melanosis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Moustafa Adam Ali El Taieb, Professor

  Dermatology, Venereology and Andrology.Faculty of Medicine, Aswan University

  STUDY CHAIR

Central Study Contacts

Heba Allah Mohamed Mustafa, Resident

CONTACT

+201151182890; HebaAllah1704336@aswu.edu.eg

Moustafa Adam Ali El Taieb, professor

CONTACT

+201092991101; moustafa.eltaib@aswu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 26, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 10, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-06

Locations

EG (1)