Recruiting

Fractional Ablative Laser

Sponsor:

Sciton

Code:

NCT05750901

Conditions

Skin Laxity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Fractional ablative laser

Study Details

Brief summary:

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

Conditions

Skin Laxity

Study ID

NCT05750901

Start date

Nov 1, 2022

Status verified date

Apr, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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. 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)
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 Informed Consent Form in English
7. Must be willing to adhere to the treatment and follow-up schedule and post-treatment care instructions

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 immunosuppression/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

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Treatment Arm

Patients will receive fractional ablative treatment for laxity.

Interventions

Fractional ablative laser

Fractional ablative laser used for treatment for skin laxity and tightening

Primary outcome measure

  • Wrinkles [ Time Frame: 1-6 months post final treatment ]

Central Contacts and Locations

Locations

Sanctuary Plastic Surgery

Recruiting

Boca Raton, Florida, United States, 33431

Contacts

Jason Pozner, MD

561-367-9101

More Information

Sponsor

Sciton

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sciton on 2026-04-23.