CompletedNot Applicable

Safety & Efficacy Evaluation of a Radiofrequency & Laser/Light System for Improvement of Skin Texture

United States61 participantsStarted 2011-10-25

Plain-language summary

Evaluate the clinical performance, safety and efficacy, of a Radiofrequency and Laser/Light based device for the treatment of facial wrinkles.

Age range35 Years – 60 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.

✓. Healthy male or female between the ages of 35 and 60
✓. Non-smoker
✓. Fitzpatrick skin type I-VI
✓. Fitzpatrick Degree of Elastosis Score of 2-6 (inclusive)
✓. Presence of mild to moderate photodamage, such as solar lentigines, dyschromia and/or presence of mild to moderate facial wrinkling
✓. Able and willing to comply with all visit, treatment and evaluation schedules and requirements
✓. Able to understand and provide written Informed Consent
✓. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.

✕. Pregnant or intending to become pregnant during the course of study. A urine pregnancy test will be given to women of childbearing potential and performed during initial visit;
✕. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
✕. Having a permanent implant in the treated area, such as metal plates and screws
✕. Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study
✕. Prior use of retinoids in treated area within 2 weeks of initial treatment or during the course of the study
✕. Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study
✕. Patient on systemic corticosteroid therapy 6 months prior to and throughout the course of the study
✕. Having received a facial dermabrasion or chemical peel treatment within 3 months of treatment or during the study

NCT IDNCT01597323

SponsorCandela Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-10-14

Who can participate

Age range35 Years – 60 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.

✓. Healthy male or female between the ages of 35 and 60
✓. Non-smoker
✓. Fitzpatrick skin type I-VI
✓. Fitzpatrick Degree of Elastosis Score of 2-6 (inclusive)
✓. Presence of mild to moderate photodamage, such as solar lentigines, dyschromia and/or presence of mild to moderate facial wrinkling
✓. Able and willing to comply with all visit, treatment and evaluation schedules and requirements
✓. Able to understand and provide written Informed Consent
✓. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.

✕. Pregnant or intending to become pregnant during the course of study. A urine pregnancy test will be given to women of childbearing potential and performed during initial visit;
✕. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
✕. Having a permanent implant in the treated area, such as metal plates and screws
✕. Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study
✕. Prior use of retinoids in treated area within 2 weeks of initial treatment or during the course of the study
✕. Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study
✕. Patient on systemic corticosteroid therapy 6 months prior to and throughout the course of the study
✕. Having received a facial dermabrasion or chemical peel treatment within 3 months of treatment or during the study