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Efficacy and Safety Trial of Using Ultra-Pulsed Shockwaves to Deliver Tranexamic Acid for the Treatment of Melasma
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-04-01
Completion Date
2024-12-30
Last Updated
2024-05-17
Healthy Volunteers
Yes
Conditions
Interventions
Ultra-pulsed Shockwave Therapy Device by Shenzhen Lifotronic Technology Co., Ltd.
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. The shockwave therapy parameters are tailored based on patient tolerance. Each patient undergoes 3 treatment sessions spaced 3 weeks apart, followed by a 4-week follow-up period. Facial skin is assessed using the VISIA system before each treatment and at the 4-week follow-up, evaluating the Melasma Area Severity Index (MASI). Patient and researcher satisfaction levels are rated on a scale of 1 to 5. Adverse reactions, including short-term effects like pain and swelling, and potential long-term effects such as allergic reactions and hyperpigmentation, are monitored after each treatment session.
Locations (1)
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China