Actively Recruiting
Fractional Erbium YAG Laser vs Intradermal and Systemic Tranexamic Acid in Combination With Topical Hydroquinone for Refractory Melasma
Led by Egymedicalpedia · Updated on 2024-07-26
45
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
Sponsors
E
Egymedicalpedia
Lead Sponsor
A
Aswan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Melasma is a common skin condition marked by brown or gray patches, mainly on sun-exposed areas like the face. It often affects people with darker skin tones and is more common in women. The exact cause of melasma is unknown but may involve genetics, sun exposure, hormones, and other factors. This trial studies treatments for refractory melasma, focusing on options combined with topical hydroquinone, to address challenges in managing this condition. The trial compares three treatment approaches: sessions with a fractional Erbium YAG laser every three weeks plus nightly topical hydroquinone 4% cream, intradermal tranexamic acid injections every three weeks alongside the same topical cream, and daily oral tranexamic acid tablets for three months with the topical cream applied each night. The laser uses a specific wavelength to target skin layers with minimal heat damage, while tranexamic acid works by reducing pigmentation through anti-inflammatory and anti-melanogenic effects. Participants will receive their assigned treatment over three months, with assessments focusing on the effectiveness of these combinations in treating refractory melasma. Researchers will monitor changes in pigmentation and treatment response. The study includes regular visits for treatment sessions and evaluations, ensuring careful observation of participant progress and treatment outcomes.
CONDITIONS
Brief Title
Fractional Erbium YAG Laser vs Intradermal and Systemic Tranexamic Acid
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of both sexes with melasma
- Age between 18 and 40 years
You will not qualify if you...
- Pregnancy
- Lactation
- Use of oral contraceptive pills or any phototoxic drug within 1 month prior to the study
- History of thrombosis or abnormal bleeding profile
- Known hypersensitivity to tranexamic acid or hydroquinone
- Endocrinal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive one of three treatments: fractional Er: YAG laser sessions every 3 weeks with topical hydroquinone cream, intradermal tranexamic acid injections every 3 weeks with nightly topical hydroquinone cream, or daily oral tranexamic acid tablets with nightly topical hydroquinone cream.
Sessions or injections every 3 weeks or daily medication with nightly cream application
Trial Site Locations
Total: 1 location
1
Aswan University hospitals
Aswān, Egypt
Actively Recruiting
Research Team
H
Heba Allah Mohamed Mustafa, Resident
M
Moustafa Adam Ali El Taieb, professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
Frequently Asked Questions
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