Efficacy and safety of high-intensity focused ultrasound in static forehead wrinkles, a randomized, evaluator-blind comparative study

Phase 4

Active, not recruiting

• Conditions: - visible static forehead wrinkles; focused ultrasound; forehead; static lines; wrinkles

• Registration Number: TCTR20190417009
• Lead Sponsor: Division of Dermatology, Department of medicine, Faculty of Medicine, Ramathibodi hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-17
• Study Completion: 2019-06-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

-visible static forehead wrinkles of the same FLSGS on both sides of the forehead

Exclusion Criteria

- Having active infection on treatment site
- Having open wound(s) on treatment site
- Having scar(s) on treatment site
- Having any cosmetic or surgical procedure on treatment site
- Having metal implant on treatment site
- Allergic to any anesthesic agents

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
forehead lines static grading scale (FLSGS) Evaluate at every visit Dermatologist evaluation of static forehead lines using visual-guided scale,Improvement score by dermatologist immediate after the treatment, 1, 3, and 6 months after treatment Dermatologist evaluation of improvement in skin laxity using visual analogue scale

Secondary Outcome Measures

Name	Time	Method
Adverse events occured Evaluate on every visit Dermatologist evaluation and patients' feedback,Improvement score by patients immediate after the treatment, 1, 3, and 6 months after treatment Patient's evaluation of improvement in skin laxity using visual analogue scale