Efficacy and Safety of 675-nm Laser for Dorsal Hand Rejuvenation

Not Applicable

Not yet recruiting

• Conditions: Wrinkle
• Interventions: Device: Redtouch

• Registration Number: NCT06486727
• Lead Sponsor: Mahidol University

Brief Summary

This study aimed to evaluate efficacy and safety of 675-nm laser for dorsal hand rejuvenation in Thai patients. Twenty-six subjects aged 50 to 65 years diagnosed with wrinkle and solar lentigines on both dorsums of hands were included and treated with RedTouch for 3 times every 4 weeks. Then, they were follow up at 3 and 6 months after the final treatment. The measurement of 5-point Global Aesthetic Improvement Scale scores by physicians and subjects were conducted. Moreover, pigmentation level, wrinkle and texture were also recored using Antera. Elasticity was measured using Cutometer.

Detailed Description

RedTouch parameter included Moveo, power 5 W, Energy/DOT 500 mJ/DOT, then Standard, power 4 W, spacing 2000 μm, 1 pass per side.

Study Timeline

• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Status Verified: 2024-07
• Study Start: 2024-07-01
• Study First Posted: 2024-07-03
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Subjects diagnosed with wrinkles and solar lentigines on both dorsum of hands

Exclusion Criteria

• Pregnant or lactation
• Sugjects with a history of allergy to near-infrared wavelength or photosensitizing agents
• Subjects who have been treated with any kind of energy-based device on both dorsum of hands 6 months prior to the inclusion
• Subjects who have been injected with filler, or platelet-rich plasma on both dorsum of hands on their faces 6 months prior to the inclusion
• Active skin infections
• History of hypertrophic scars or keloids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
675-nm laser (RedTouch)	Redtouch	Paramete: Moveo, power 5 W, Energy/DOT 500 mJ/DOT then Standard, power 4 W, spacing 2000 μm, 1 pass per side for 4 times with 4-week interval

Primary Outcome Measures

Name	Time	Method
The change in pigmentation level, wrinkle and texture	Baseline, 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment	Using Antera®

Secondary Outcome Measures

Name	Time	Method
The change in elasticity	Baseline, 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment	Using Cutometer®
Overall improvement by physicians and patients	4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment	5-point GAIS
Adverse events	4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment	Side effects
Pain score	Baseline, 4, 8, 12 weeks after the first treatment	Visual analog scale (0-10; no pain-worst pain possible)