NCT06522984

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Egymedicalpedia · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Refractory Melasma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-06-01
• Completion: 2025-06-10
• First posted: 2024-07-26
• Last updated: 2024-07-26

Locations

1 site across 1 country: Egypt