Evaluation of a laser treatment for skin laxity

Pilot Evaluation of Fractional Ablative Laser Treatment for Skin Laxity and Tightening

This study is testing a laser treatment to see if it can help tighten loose skin and improve scars in men and women aged 18 to 85.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Sciton (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Boca Raton, Florida)
• Trial ID: NCT05750901 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of fractional ablative laser treatment aimed at improving skin laxity and tightening. Participants will undergo the laser treatment, and their skin condition will be assessed through digital imaging and measurements. The study includes both male and female subjects aged 18-85 with visible skin laxity or scars, ensuring a diverse representation of Fitzpatrick skin types I-VI. Participants must adhere to specific eligibility criteria and follow-up care instructions throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 with visible skin laxity or scars and Fitzpatrick skin types I-VI.

Not a fit: Patients with prior cosmetic treatments in the target area or those participating in other clinical trials within the last six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve skin appearance and firmness for patients experiencing skin laxity.

How similar studies have performed: Other studies have shown promising results with similar laser treatments for skin conditions, indicating potential for success in this approach.

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

Where this trial is running

Boca Raton, Florida

• Sanctuary Plastic Surgery — Boca Raton, Florida, United States (RECRUITING)

Study contacts

• Study coordinator: Sciton Inc.

Conditions: Skin Laxity