Actively Recruiting
Pilot Evaluation of Fractional Ablative Laser Treatment for Skin Laxity and Tightening
Led by Sciton · Updated on 2026-04-23
1000
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a fractional ablative laser device for treating skin laxity and tightening. The study aims to assess how well this laser treatment works in improving skin appearance, particularly focusing on wrinkle reduction. This pilot evaluation is sponsored by Sciton and includes adults aged 18 to 85 years with visible skin laxity or scars. Participants will receive fractional ablative laser treatment targeted at areas with skin laxity. The study involves a single treatment arm where this device is applied to improve skin tightness. There are no placebo or comparison groups, and the treatment details focus on applying the laser to affected skin regions. During the study, participants will have digital images and measurements taken of the treated area to monitor changes over time. Researchers will track wrinkle improvement for up to six months after the final treatment. Participants must follow treatment and follow-up schedules, including post-treatment care instructions. The total study duration and additional monitoring details are not specified but include these outcome assessments and safety observations.
CONDITIONS
Brief Title
Evaluation of Fractional Ablative Laser Treatment for Skin Conditions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18-85 years
- Fitzpatrick skin type I-VI
- Visible skin laxity in the treatment region or presence of a scar
- Female subjects must be post-menopausal, surgically sterilized, or using medically acceptable birth control for at least 3 months prior and during the study, with no plans to become pregnant
- Willing to have digital imaging and measurements taken of the treatment area for presentation or educational use
- Able to read, understand, and sign informed consent in English
- Willing to follow treatment, follow-up schedules, and post-treatment care instructions
You will not qualify if you...
- Participated in another clinical trial involving a device or drug within 6 months prior or during this study
- Prior cosmetic treatments to the target area at physician's discretion
- History of malignant tumors in the target area
- Skin abnormalities in the treatment area such as cuts, scrapes, wounds, or large moles
- Pregnant or breastfeeding females
- Infection, dermatitis, or rash in the treatment area
- Significant illnesses like diabetes, cardiovascular disease (e.g., uncontrolled hypertension), or neurological disorders
- Coagulation disorders or use of prescription anticoagulants
- History of keloid or hypertrophic scarring, or abnormal wound healing
- Immunosuppression or immune deficiency disorders, or use of immunosuppressive medications
- History of vitiligo, eczema, or psoriasis
- History of heat-stimulated diseases such as recurrent herpes simplex or herpes zoster in the treatment area unless prophylaxis is given
- History of radiation or systemic chemotherapy to the treatment area
- Current smoker or smoked within 6 months prior to participation
- Any physical or mental condition that may make participation unsafe as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration not specified
Participants receive fractional ablative laser treatment for skin laxity and tightening.
1 treatment visit
Duration - 1 to 6 months post final treatment
Participants are monitored for treatment outcomes such as wrinkles for 1 to 6 months post final treatment.
Follow-up visits as scheduled
Trial Site Locations
Total: 1 location
1
Sanctuary Plastic Surgery
Boca Raton, Florida, United States, 33431
Actively Recruiting
Research Team
S
Sciton Inc.
S
Sciton Inc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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