Evaluation of Fractional Ablative Laser Treatment for Skin Conditions

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

Study Overview

• Status: Recruiting
• Conditions: Skin Laxity
• Intervention / Treatment: Device: Fractional ablative laser

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sciton Inc.; Phone Number: 6504939155; Email: clinicaltrials@sciton.com
• Study Contact Backup: Name: Sciton Inc; Phone Number: 6504939155; Email: clinicaltrials@sciton.com

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Recruiting
      • Sanctuary Plastic Surgery
      • Contact: Jason Pozner, MD; Phone Number: 561-367-9101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment Arm; Patients will receive fractional ablative treatment for laxity.	Device: Fractional ablative laser; Fractional ablative laser used for treatment for skin laxity and tightening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrinkles	Percent improvement in wrinkles will be assessed using digital camera at baseline and post final treatment.	1-6 months post final treatment

Collaborators and Investigators

• Sponsor: Sciton

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): January 20, 2025

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa
• Other Study ID Numbers: LC-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No