Fractional Erbium YAG Laser vs Intradermal and Systemic Tranexamic Acid

Last updated: July 23, 2024
Sponsor: Egymedicalpedia
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Tranexamic acid injection

Clinical Study ID

NCT06522984
Heba Allah Mohamed Mustafa
  • Ages 18-40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients of both sexes with melasma.

Exclusion

Exclusion Criteria:

  • Pregnancy

  • Lactation

  • Administration of oral contraceptive pills or any phototoxic drug within 1 monthprior to study

  • Patients with a history of thrombosis, abnormal bleeding profile, knownhypersensitivity to TA or HQ, and endocrinal disease.

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: Tranexamic acid injection
Phase:
Study Start date:
June 01, 2024
Estimated Completion Date:
June 10, 2025

Study 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.

Connect with a study center

  • Aswan University hospitals

    Aswan,
    Egypt

    Active - Recruiting

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