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

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

September 30, 2024

Study Completion Date

December 30, 2024

Conditions
Chloasma
Interventions
DEVICE

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.

Trial Locations (1)

310009

RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
lead

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER