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NCT Number: NCT06486727

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

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.

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Key information

Conditions

Wrinkle

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Redtouch

Device

675-nm laser

Primary outcomes

  1. The change in pigmentation level, wrinkle and texture

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

    Using Antera®

Secondary outcomes

  1. The change in elasticity

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

    Using Cutometer®

  2. Overall improvement by physicians and patients

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

    5-point GAIS

  3. Adverse events

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

    Side effects

  4. Pain score

    Time frame: Baseline, 4, 8, 12 weeks after the first treatment

    Visual analog scale (0-10; no pain-worst pain possible)

Study contacts

Contact information is provided by the study sponsor or research team.

Supisara Wongdama, MD

CONTACT

[email protected]

66869898613

Woraphong Manuskiatti, MD

CONTACT

[email protected]

6624194333

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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