ClinicalTrials.gg
RecruitingNCT05750901Updated Apr 23, 2026

Evaluation of Fractional Ablative Laser Treatment for Skin Conditions

An interventional study of Fractional ablative laser in Skin Laxity, sponsored by Sciton. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Sciton · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Nov 2022, registered Feb 2023).
  • Started Nov 2022; still recruiting 4 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Evaluate the safety and efficacy of the fractional ablative laser for treatment of skin laxity and tightening

02

Conditions studied

  • Skin Laxity
03

In context

Lead sponsor

Sciton is the lead sponsor of 15 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female subjects aged 18-85 years
  2. Fitzpatrick skin type I-VI
  3. Has visible skin laxity in the treatment region or has a scar
  4. or surgically sterilized, or using a medically acceptable form of 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)
  5. Willing to have digital imaging and measurements taken of the treatment area and agree to use for presentation, educational or marketing purposes
  6. Subject must be able to read, understand and sign Form in English
  7. Must be willing to adhere to the treatment and follow-up schedule and post-treatment care instructions

Exclusion criteria

Exclusion Criteria:

  1. Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
  2. Any type of prior cosmetic treatment to the target area at physicians' discretion
  3. History of malignant tumors in the target area.
  4. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, large moles.
  5. Pregnant and/or breastfeeding (Applicable to females only)
  6. Having an infection, dermatitis or a rash in the treatment area.
  7. Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, e.g., uncontrolled hypertension or pertinent neurological disorders.
  8. Suffering from coagulation disorders or taking prescription anticoagulation medications.
  9. History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
  10. History of /immune deficiency disorders or currently using immunosuppressive medications.
  11. History of vitiligo, eczema, or psoriasis.
  12. 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.
  13. History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
  14. Current smoker or history of smoking within 6 months of study participation.
  15. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Other
    Treatment Arm

    Patients will receive fractional ablative treatment for laxity.

    Device: Fractional ablative laser

Interventions

  • DeviceFractional ablative laser

    Fractional ablative laser used for treatment for skin laxity and tightening

06

What researchers measure

Primary outcomes

  1. Wrinkles

    Percent improvement in wrinkles will be assessed using digital camera at baseline and post final treatment.

    Time frame: 1-6 months post final treatment

07

Study locations

1 of 1 sites recruiting
  • Sanctuary Plastic Surgery
    Boca Raton, Florida 33431, United States
    Recruiting
    • Jason Pozner, MD · Contact561-367-9101
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05750901
Lead sponsor
Sciton
Responsible party
Sponsor
First posted
Mar 2, 2023
Start date
Nov 1, 2022
Primary completion
Dec 20, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Apr 23, 2026

Study contacts

Sciton Inc.
Contact
clinicaltrials@sciton.com
6504939155
Sciton Inc
Contact
clinicaltrials@sciton.com
6504939155

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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