WrinkleNCT06486727
Efficacy and Safety of 675-nm Laser for Dorsal Hand Rejuvenation
A study testing Redtouch in people with Wrinkle, run by Mahidol University.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- Redtouch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with wrinkles and solar lentigines on both dorsum of hands
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of 675-nm Laser for Dorsal Hand Rejuvenation in Thai Patients
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.
Read the 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
- Being tested
- Redtouch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RedtouchDevice
675-nm laser
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Redtouch |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in pigmentation level, wrinkle and texture
Using Antera®
Measured: Baseline, 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment
Secondary outcomes (4)
The change in elasticity
Using Cutometer®
Measured: Baseline, 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment
Overall improvement by physicians and patients
5-point GAIS
Measured: 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment
Adverse events
Side effects
Measured: 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment
Pain score
Visual analog scale (0-10; no pain-worst pain possible)
Measured: Baseline, 4, 8, 12 weeks after the first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woraphong Manuskiatti, M.D., Mahidol University
- Investigators
- Woraphong Manuskiatti, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486727
- Sponsor's protocol ID
- Si 488/2024
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 675-nm Laser for Dorsal Hand Rejuvenation in Thai Patients
- ClinicalTrials.gov ID
- NCT06486727
- Acronym / sponsor ID
- Si 488/2024
- Conditions
- Wrinkle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 675-nm laser (RedTouch) | Experimental | Device: RedtouchParamete: 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 |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects diagnosed with wrinkles and solar lentigines on both dorsum of hands
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Redtouch675-nm laser | Device | 675-nm laser (RedTouch) |
Primary outcome
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®
4 secondary outcomes
The change in elasticity
Time frame: Baseline, 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment
Overall improvement by physicians and patients
Time frame: 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment
Adverse events
Time frame: 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment
Pain score
Time frame: Baseline, 4, 8, 12 weeks after the first treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woraphong Manuskiatti, MD principal investigator
Mahidol University
Questions about this trial
What is this clinical trial studying?
A study testing Redtouch in people with Wrinkle, run by Mahidol University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Woraphong Manuskiatti, MD (6624194333, doctorlaser@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.