Evaluation of Fractional Ablative Laser Treatment for Skin Conditions

Recruiting now · Not applicable

Conditions studied: Skin Laxity

In brief

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

Key facts

Study ID

NCT05750901

Run by

Sciton

People needed

1000

Starts

2022-11-01

Expected to finish

2027-12-30

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female subjects aged 18-85 years
• Fitzpatrick skin type I-VI
• Has visible skin laxity in the treatment region or has a scar
• 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)
• Willing to have digital imaging and measurements taken of the treatment area and agree to use for presentation, educational or marketing purposes
• Subject must be able to read, understand and sign Informed Consent Form in English
• Must be willing to adhere to the treatment and follow-up schedule and post-treatment care instructions

You may not qualify if…

• Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
• Any type of prior cosmetic treatment to the target area at physicians' discretion
• History of malignant tumors in the target area.
• Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, large moles.
• Pregnant and/or breastfeeding (Applicable to females only)
• Having an infection, dermatitis or a rash in the treatment area.
• Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, e.g., uncontrolled hypertension or pertinent neurological disorders.
• Suffering from coagulation disorders or taking prescription anticoagulation medications.
• History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
• History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
• History of vitiligo, eczema, or psoriasis.
• 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.
• History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
• Current smoker or history of smoking within 6 months of study participation.
• 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 it is running

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

Full record on ClinicalTrials.gov

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