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

NCT06418568 | Recruiting

• 1 other identifier: 2023-1174
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chloasma

Outcome Measures

Primary Outcomes (1)

• Melasma area severity index(MASI)

  The Melasma Area Severity Index (MASI) is a clinical scoring system used to assess the severity of melasma based on the extent and darkness of pigmented areas on the face. It takes into account four different facial regions: the forehead, cheeks (right and left), and chin. The MASI score is calculated using the following formula: MASI=0.3×(DF+DB)×AF+0.3×(RF+RB)×AF+0.3×(CF+CB)×AF+0.1×(LF+LB)×AF The MASI score ranges from 0 to approximately 48, with higher scores indicating more severe melasma. It is used to quantify and monitor changes in melasma severity over time in response to treatment interventions.

  3 months

Secondary Outcomes (1)

• Physician's Global Assessment (PGA)

  3 months

Study Arms (1)

Patients with chloasma

EXPERIMENTAL

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.

Device: Ultra-pulsed Shockwave Therapy Device by Shenzhen Lifotronic Technology Co., Ltd.

Interventions

Ultra-pulsed Shockwave Therapy Device by Shenzhen Lifotronic Technology Co., Ltd. DEVICE

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.

Patients with chloasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of other pigmentary disorders such as lentigines, Ota nevus, freckles, etc.;
• History of oral retinoid or tetracycline-class photosensitizing drugs within the past 6 months prior to treatment;
• History of facial injections, fillers, chemical peels, laser or radiofrequency treatments, or other treatments targeting pigmentation within the past 6 months prior to treatment;
• Abnormal coagulation function;
• History of oral glucocorticoids or immunosuppressive agents within the past 3 months prior to treatment;
• Patients with malignant tumors;
• Pregnant or lactating women;
• Patients with active herpes simplex or herpes zoster on the face.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

SuiQing Cai, PHD

CONTACT

13957107910; 2465598440@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 17, 2024
• Study Start: April 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-04

Locations

CN (1)