Fractional Erbium YAG Laser vs Intradermal and Systemic Tranexamic Acid

Fractional Erbium YAG Laser vs Intradermal and Systemic Tranexamic Acid in Combination With Topical Hydroquinone for Refractory Melasma

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.

Study Overview

• Status: Recruiting
• Conditions: Refractory Melasma
• Intervention / Treatment: Drug: Tranexamic acid injection

Detailed Description

Melasma is more common in people with dark complexions and Fitzpatrick skin types III IV.Depending on ethnicity and region, melasma prevalence might vary from 8.8% to 40%. The cause of melasma is still unknown in the meantime.

Numerous elements, including genetics, sunshine, endocrine stimulation, oxidative conditions,pregnancy, exogenous hormons,and morphofunctional changes, may have a role in the development of the disease.

Since melasma is a common skin condition affecting mostly pregnant women and those on hormonal birth control, it is known as the "mask of pregnancy,

Treatment for melasma remains a challenge, with substantial psychosocial ramifications. Many factors, including variability in clinical presentation and responsiveness to treatment between genders, skin phototypes, and ethnicities, can affect treatment efficacy. None of variety methods have been sufficiently effective to be considered the gold standard.

Hydroquinone (HQ) has historically been the most studied topical agent in the treatment of melasma. HQ is a hydroxyphenolic compound that inhibits the conversion of dopa to melanin by the inhibition of tyrosinase; it also inhibits RNA and DNA synthesis of melanocytes and degrades melanosomes.

Tranexamic acid (TXA) is an antifibrinolytic drug that has been used off-label for the treatment of melasma, as an oral or intradermal injection.

TXA is a lysine-derived amino acid with anti-inflammatory effects that prevents ultraviolet (UV)-induced skin pigmentation by inhibiting attachment of plasminogen to keratinocytes and activation of plasmin. Plasmin stimulates melanogenesis by conversionof arachidonic acid to prostaglandin and leukotriene. On the other hand, plasmin increases the level of melanogenic factors.

Laser therapy is a unique ablative modality that might potentially increase the penetration of medications applied topically by destroying the SC, epidermal, and dermal layers of the skin in a predictable and controlled manner.

The Fractional erbiumdoped yttrium aluminum garnet (Er: YAG) laser has a wavelength of 2,940 nm and is strongly absorbed by water in the epidermis. It exerts its ablation effect with minimal penetration depth and minimal heat generation and therefore minimal thermal damage.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heba Allah Mohamed Mustafa, Resident; Phone Number: +201151182890; Email: HebaAllah1704336@aswu.edu.eg
• Study Contact Backup: Name: Moustafa Adam Ali El Taieb, professor; Phone Number: +201092991101; Email: moustafa.eltaib@aswu.edu.eg

Study Locations

• Egypt
  • Aswan, Egypt
    • Recruiting
    • Aswan university hospitals
    • Contact: Mahmoud Ahmed Ali, M.D; Phone Number: +201002364902; Email: dr.mahmoudali@aswu.edu.eg
    • Contact: Mohamed Amer Ahmed Abdellatif, M.D; Phone Number: +201060394083; Email: mohammed.abdellatif@aswu.edu.eg
    • Principal Investigator: Heba Allah Mohamed Mustafa, Resident

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Patients of both sexes with melasma.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; 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; 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.; Other Names: Fractional erbium YAG laser
Active Comparator: Group B; 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; 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.; Other Names: Fractional erbium YAG laser
Active Comparator: Group C; 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; 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.; Other Names: Fractional erbium YAG laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Egymedicalpedia
• Collaborators: Aswan University
• Investigators: Study Chair: Moustafa Adam Ali El Taieb, Professor, Dermatology, Venereology and Andrology.Faculty of Medicine, Aswan University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 10, 2025

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: June 1, 2024

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: Heba Allah Mohamed Mustafa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No