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

NCT06486727 | Not Yet Recruiting FDA Device

• 1 other identifier: Si 488/2024
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (1)

• The change in pigmentation level, wrinkle and texture

  Using Antera®

  Baseline, 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment

Secondary Outcomes (4)

• The change in elasticity

  Baseline, 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment

• Overall improvement by physicians and patients

  4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment

• Adverse events

  4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment

• Pain score

  Baseline, 4, 8, 12 weeks after the first treatment

Study Arms (1)

675-nm laser (RedTouch)

EXPERIMENTAL

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

Device: Redtouch

Interventions

Redtouch DEVICE

675-nm laser

675-nm laser (RedTouch)

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or lactation
• Sugjects with a history of allergy to near-infrared wavelength or photosensitizing agents
• Active skin infections
• History of hypertrophic scars or keloids

Sponsors & Collaborators

• Mahidol University: lead

Study Officials

• Woraphong Manuskiatti, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Woraphong Manuskiatti, MD

CONTACT

6624194333; doctorlaser@gmail.com

Supisara Wongdama, MD

CONTACT

66869898613; popsupdm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 3, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share