Fractional Erbium YAG Laser vs Intradermal and Systemic Tranexamic Acid
NCT ID: NCT06522984
Last Updated: 2024-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
45 participants
INTERVENTIONAL
2024-06-01
2025-06-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Laser and Tranexamic Acid in Treatment of Melasma
NCT04599205
Tranexamic Acid vs. Combination With Fractional Carbon Dioxide Laser in Melasma
NCT03899233
Combined Q-switched Nd:YAG Laser and Platelet Rich Plasma Versus Q- Switched Nd:YAG Laser Alone in Melasma
NCT04765930
A Clinical Observation of 1064-nm Q-Switched Fractional Laser Combined With Oral Tranexamic Acid on Treating of Melasma.
NCT03963466
1064-nm Q-switched Nd:YAG Laser and Intradermal Tranexamic Acid for Melasma
NCT03008655
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
About 15 cases will receive sessions with fractional Er: YAG laser every 3 weeks followed by application of topical 4% (HQ) cream.
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.
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
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aswan University
OTHER
Egymedicalpedia
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Moustafa Adam Ali El Taieb, Professor
Role: STUDY_CHAIR
Dermatology, Venereology and Andrology.Faculty of Medicine, Aswan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aswan University hospitals
Aswān, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Heba Allah Mohamed Mustafa
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.