Skin LaxityNCT05750901
Evaluation of Fractional Ablative Laser Treatment for Skin Conditions
A study testing Fractional ablative laser in people with Skin Laxity, run by Sciton at 1 site in United States.
Trial summary
Evaluate the safety and efficacy of the fractional ablative laser for treatment of skin laxity and tightening Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- Fractional ablative laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18-85 years
- Fitzpatrick skin type I-VI
- Has visible skin laxity in the treatment region or has a scar
- Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant for the duration of the study (Applicable to female subjects only)
- Willing to have digital imaging and measurements taken of the treatment area and agree to use for presentation, educational or marketing purposes
- Subject must be able to read, understand and sign Informed Consent Form in English
- Must be willing to adhere to the treatment and follow-up schedule and post-treatment care instructions
Who cannot join
- Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
- Any type of prior cosmetic treatment to the target area at physicians' discretion
- History of malignant tumors in the target area.
- Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, large moles.
- Pregnant and/or breastfeeding (Applicable to females only)
- Having an infection, dermatitis or a rash in the treatment area.
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- Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, e.g., uncontrolled hypertension or pertinent neurological disorders.
- Suffering from coagulation disorders or taking prescription anticoagulation medications.
- History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- History of vitiligo, eczema, or psoriasis.
- History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
- History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
- Current smoker or history of smoking within 6 months of study participation.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sanctuary Plastic Surgery
Boca Raton, Florida, 33431
Jason Pozner, MD, 561-367-9101
About this study
Official title: Pilot Evaluation of Fractional Ablative Laser Treatment for Skin Laxity and Tightening
Evaluate the safety and efficacy of the fractional ablative laser for treatment of skin laxity and tightening
- Conditions
- Skin Laxity
- Being tested
- Fractional ablative laser
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional ablative laserDevice
Fractional ablative laser used for treatment for skin laxity and tightening
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Other | Patients will receive fractional ablative treatment for laxity. Receives: Device: Fractional ablative laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrinkles
Percent improvement in wrinkles will be assessed using digital camera at baseline and post final treatment.
Measured: 1-6 months post final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Nov 2022
- Primary completion20 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies of the same condition, open and under way.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sciton
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750901
- Sponsor's protocol ID
- LC-001
- Status last verified
- Apr 2026
- First submitted
- 8 Feb 2023
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of Fractional Ablative Laser Treatment for Skin Laxity and Tightening
- ClinicalTrials.gov ID
- NCT05750901
- Acronym / sponsor ID
- LC-001
- Conditions
- Skin Laxity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- ScitonIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 2 Mar 2023 (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.
Evaluate the safety and efficacy of the fractional ablative laser for treatment of skin laxity and tightening
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Other | Device: Fractional ablative laserPatients will receive fractional ablative treatment for laxity. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects aged 18-85 years
- Fitzpatrick skin type I-VI
- Has visible skin laxity in the treatment region or has a scar
- Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant for the duration of the study (Applicable to female subjects only)
- Willing to have digital imaging and measurements taken of the treatment area and agree to use for presentation, educational or marketing purposes
Key exclusion criteria (15 listed)
- Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
- Any type of prior cosmetic treatment to the target area at physicians' discretion
- History of malignant tumors in the target area.
- Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, large moles.
- Pregnant and/or breastfeeding (Applicable to females only)
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 |
|---|---|---|
| Fractional ablative laserFractional ablative laser used for treatment for skin laxity and tightening | Device | Treatment Arm |
Primary outcome
Wrinkles
Time frame: 1-6 months post final treatment
Percent improvement in wrinkles will be assessed using digital camera at baseline and post final treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional ablative laser in people with Skin Laxity, run by Sciton at 1 site in United States.
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 7 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sciton Inc. (6504939155, clinicaltrials@sciton.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrinkles (time frame: 1-6 months post final 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 23 Apr 2026.