Efficacy and Safety Trial of Using Ultra-Pulsed Shockwaves to Deliver Tranexamic Acid for the Treatment of Melasma

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Melasma is a prevalent chronic facial pigmentation condition affecting Asian women of childbearing age, attributed to genetic predisposition, sunlight exposure, and hormonal changes. Treatment methods include phototherapy and medication, notably tranexamic acid, which inhibits melanin production. Ultra-pulsed shockwave therapy is a non-invasive approach that boosts skin cell vitality and collagen synthesis. Currently, there is a lack of comprehensive research on the effectiveness and safety of using ultra-pulsed shockwaves to deliver tranexamic acid for melasma treatment. This study will involve a non-randomized, self-half-face, pre-post controlled prospective clinical trial. This design aims to evaluate the depigmenting effects and safety profile of tranexamic acid delivered via ultra-pulsed shockwaves.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Age ≥ 18 years, any gender;

• Diagnosis of melasma;

• Able to comprehend and voluntarily sign a written informed consent form, and able to complete the treatment and follow-up as required.

Locations
Other Locations
China
The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
SuiQing Cai, PHD
2465598440@qq.com
13957107910
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 60
Treatments
Experimental: Patients with chloasma
The intervention involves treating melasma using tranexamic acid (aminomethylbenzoic acid) delivered through ultra-pulsed shockwave therapy on one side of the face, while the other side receives topical application of tranexamic acid at the same concentration.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov

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