Evaluation of Fractional Ablative Laser Treatment for Skin Conditions
Evaluate the safety and efficacy of the fractional ablative laser for treatment of skin laxity and tightening
Conditions:
🦠 Skin Laxity
🗓️ Study Start (Actual) 1 November 2022
🗓️ Primary Completion (Estimated) 30 December 2024
✅ Study Completion (Estimated) 20 January 2025
👥 Enrollment (Estimated) 1000
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boca Raton, Florida, United States

📋 Eligibility Criteria

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
Ages Eligible for Study: 18 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 February 2023
  • First Submitted that Met QC Criteria 27 February 2023
  • First Posted 2 March 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 April 2024
  • Last Update Posted 11 April 2024
  • Last Verified April 2024