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

NCT ID: NCT06486727

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-12-01

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.

Conditions

Wrinkle

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

675-nm laser (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

Group Type: EXPERIMENTAL

Redtouch

Intervention Type: DEVICE

675-nm laser

Interventions

Redtouch

675-nm laser

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Woraphong Manuskiatti, M.D.

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Woraphong Manuskiatti, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Central Contacts

Woraphong Manuskiatti, MD

Role: CONTACT

doctorlaser@gmail.com

6624194333

Supisara Wongdama, MD

Role: CONTACT

popsupdm@gmail.com

66869898613

Other Identifiers

Si 488/2024

Identifier Type: -

Identifier Source: org_study_id