Evaluation of Fractional Ablative Laser Treatment for Skin Conditions
ConditionSkin Laxity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSciton
About this trial
Evaluate the safety and efficacy of the fractional ablative laser for treatment of skin laxity and tightening
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Fractional ablative laser
DeviceFractional ablative laser used for treatment for skin laxity and tightening
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Treatment ArmOther 1 intervention
Trial outcomes
Primary outcomes
1
Wrinkles
Percent improvement in wrinkles will be assessed using digital camera at baseline and post final treatment.
Time frame
1-6 months post final treatment Source ClinicalTrials.gov