Clinical trial NCT06522984: Fractional Erbium YAG Laser vs Intradermal and Systemic Tranexamic Acid
Official title: Fractional Erbium YAG Laser vs Intradermal and Systemic Tranexamic Acid in Combination With Topical Hydroquinone for Refractory Melasma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Refractory Melasma
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
Collaborators: name: Aswan University
First posted: 2024-07-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Refractory Melasma Treatment combination with topical hydroquinone
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University hospitals
Study officials:
affiliation: Dermatology, Venereology and Andrology.Faculty of Medicine, Aswan University
name: Moustafa Adam Ali El Taieb, Professor
role: STUDY_CHAIR
References: