Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
ID06522984

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

Age: 18Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients of both sexes with melasma
  • Age between 18 and 40 years
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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

Have more questions? Get in touch with our team for quick support

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