Evaluation of Fractional Ablative Laser Treatment for Skin Conditions

NCT ID: NCT05750901

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2026-06-20

Brief Summary

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

Conditions

Skin Laxity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Patients will receive fractional ablative treatment for laxity.

Group Type: OTHER

Fractional ablative laser

Intervention Type: DEVICE

Fractional ablative laser used for treatment for skin laxity and tightening

Interventions

Fractional ablative laser

Fractional ablative laser used for treatment for skin laxity and tightening

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sciton

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sanctuary Plastic Surgery

Boca Raton, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sciton Inc.

Role: CONTACT

clinicaltrials@sciton.com

6504939155

Sciton Inc

Role: CONTACT

clinicaltrials@sciton.com

6504939155

Facility Contacts

Jason Pozner, MD

Role: primary

561-367-9101

Other Identifiers

LC-001

Identifier Type: -

Identifier Source: org_study_id