Laxity; SkinNCT06231914
Efficacy and Safety of Fractional 1064-nm Picosecond Laser for Facial Skin Tightening
A study testing StarWalker® PQX in people with Laxity; Skin, run by Mahidol University at 1 site in Thailand.
Trial summary
The goal of this clinical trial is to learn the efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening. The main questions it aims to answer are: Efficacy of fractional 1064-nm picosecond laser for facial skin efficacy including the changes in wrinkle, nasolabial fold, skin laxity, and… Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Laxity; Skin
- What is being tested?
- StarWalker® PQX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 1 Dec 2023to 1 Mar 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 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 40-55 years
- BMI < 25 kg/m2
- Asian
- Mild to moderate facial skin laxity using quantitative grading scale (grade 1.5-2.5)
Who cannot join
- Pregnant or lactation
- Subjects who have been treated with any kind of energy-based device 6 months prior to the inclusion
- Subjects who have been injected with botulinum toxin, filler, or platelet-rich plasma on their faces 6 months prior to the inclusion
- Active skin infections
- History of hypertrophic scars or keloids
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of Dermatology, Siriraj Hospital, Mahidol University
Bangkok, 10700
Woraphong Manuskiatti, M.D., 66869898613, doctorlaser@gmail.com
Woraphong Manuskiatti, M.D.
About this study
The goal of this clinical trial is to learn the efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening. The main questions it aims to answer are:
- Efficacy of fractional 1064-nm picosecond laser for facial skin efficacy including the changes in wrinkle, nasolabial fold, skin laxity, and skin elasticity
- The changes in texture and pore volume using Antera
- The changes in bioengineering assessment: melanin index, erythema index, sebum level
- Adverse events Participants will be treated with 3 sessions of fractional 1064-nm picosecond laser (full face 4 passes, vector lines 4 passes), spaced 4 weeks apart. Follow-up visits 1, 3, and 6 months after the last treatments.
Read the detailed description
The efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening in participants aged 40 to 55 years, BMI < 25 kg/m2, and have mild to moderate facial laxity.
- Conditions
- Laxity; Skin
- Being tested
- StarWalker® PQX
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StarWalker® PQXDevice
Third-generation ASP-powered technology for ultra performance: Highest pico power \& energy, shortest pico pulse width, wide range of laser wavelengths, exceptional spot size capabilities, largest fluence spectrum for flat-top handpieces
| Study group | Role | What they receive |
|---|---|---|
| Fractional 1064-nm Picosecond laser | Experimental | Fractional 1064-nm Picosecond laser for 3 sessions, at 4-week interval Receives: Device: StarWalker® PQX |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in wrinkle.
The changes in indentation of wrinkle using Antera (mm3)
Measured: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
The changes in nasolabial fold.
The changes in nasolabial fold using Quantificare (mm3)
Measured: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
The changes in skin laxity.
The changes in skin laxity using Quantificare (mm3)
Measured: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
The changes in skin elasticity.
The changes in skin elasticity (R0, R2, R5) using Cutometer (%)
Measured: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
Secondary outcomes (5)
The changes in skin texture.
The measurement will be done using Antera (mm3)
Measured: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
The changes in pore volume.
The measurement will be done using Antera (mm3)
Measured: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
The change in melanin index and erythema index.
The measurement of bioengineering assessment including melanin index and erythema index using Mexameter (%)
Measured: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
The change in sebum level.
The change in sebum production using Sebumeter (%)
Measured: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
Adverse events
Adverse events that occurred during the study protocol
Measured: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Dec 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laxity; SkinStudies 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
- 30 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
- NCT06231914
- Sponsor's protocol ID
- Si 981/2023
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fractional 1064-nm Picosecond Laser for Facial Skin Tightening
- ClinicalTrials.gov ID
- NCT06231914
- Acronym / sponsor ID
- Si 981/2023
- Conditions
- Laxity; Skin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 30 Jan 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.
The goal of this clinical trial is to learn the efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening. The main questions it aims to answer are:
- Efficacy of fractional 1064-nm picosecond laser for facial skin efficacy including the changes in wrinkle, nasolabial fold, skin laxity, and skin elasticity
- The changes in texture and pore volume using Antera
- The changes in bioengineering assessment: melanin index, erythema index, sebum level
- Adverse events Participants will be treated with 3 sessions of fractional 1064-nm picosecond laser (full face 4 passes, vector lines 4 passes), spaced 4 weeks apart. Follow-up visits 1, 3, and 6 months after the last treatments.
Detailed description
The efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening in participants aged 40 to 55 years, BMI < 25 kg/m2, and have mild to moderate facial laxity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fractional 1064-nm Picosecond laser | Experimental | Device: StarWalker® PQXFractional 1064-nm Picosecond laser for 3 sessions, at 4-week interval |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 40-55 years
- BMI < 25 kg/m2
- Asian
- Mild to moderate facial skin laxity using quantitative grading scale (grade 1.5-2.5)
Key exclusion criteria (5 listed)
- Pregnant or lactation
- Subjects who have been treated with any kind of energy-based device 6 months prior to the inclusion
- Subjects who have been injected with botulinum toxin, filler, or platelet-rich plasma on their faces 6 months prior to the inclusion
- Active skin infections
- History of hypertrophic scars or keloids
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 |
|---|---|---|
| StarWalker® PQXThird-generation ASP-powered technology for ultra performance: Highest pico power \& energy, shortest pico pulse width, wide range of laser wavelengths, exceptional spot size capabilities, largest fluence spectrum for flat-top handpieces | Device | Fractional 1064-nm Picosecond laser |
Primary outcome
The changes in wrinkle.
Time frame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
The changes in indentation of wrinkle using Antera (mm3)
The changes in nasolabial fold.
Time frame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
The changes in nasolabial fold using Quantificare (mm3)
The changes in skin laxity.
Time frame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
The changes in skin laxity using Quantificare (mm3)
The changes in skin elasticity.
Time frame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
The changes in skin elasticity (R0, R2, R5) using Cutometer (%)
5 secondary outcomes
The changes in skin texture.
Time frame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
The changes in pore volume.
Time frame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
The change in melanin index and erythema index.
Time frame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
The change in sebum level.
Time frame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
Adverse events
Time frame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StarWalker® PQX in people with Laxity; Skin, run by Mahidol University at 1 site in Thailand.
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 4 inclusion and 5 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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 changes in wrinkle. (time frame: 4 weeks after the first treatment, 4 weeks after the second treatment, during 1, 3, and 6 months after the last treatment.). The study lists 4 primary outcomes in all. 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 30 Jan 2024.