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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06522984
Enrollment
45
Registered
2024-07-26
Start date
2024-06-01
Completion date
2025-06-10
Last updated
2024-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Melasma

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.

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.

Interventions

DRUGTranexamic 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.

Sponsors

Aswan University
CollaboratorOTHER
Egymedicalpedia
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Refractory Melasma Treatment combination with topical hydroquinone3 monthsto 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).

Countries

Egypt

Contacts

Primary ContactHeba Allah Mohamed Mustafa, Resident
HebaAllah1704336@aswu.edu.eg+201151182890
Backup ContactMoustafa Adam Ali El Taieb, professor
moustafa.eltaib@aswu.edu.eg+201092991101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026