RecruitingNot Applicable

Evaluation of Fractional Ablative Laser Treatment for Skin Conditions

United States1,000 participantsStarted 2022-11-01

Plain-language summary

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

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.

Wrinkles

Timeframe: 1-6 months post final treatment

NCT IDNCT05750901

SponsorSciton

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-20

Sciton Inc.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.