CompletedNot Applicable

Fractional Radiofrequency for the Treatment and Reduction of Acne Scars and Wrinkles

United States10 participantsStarted 2019-08-19

Plain-language summary

The objective of this clinical study is to evaluate the efficacy of fractional RF for the treatment and reduction of acne scarring or facial wrinkles.

Who can participate

Age range22 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.

Inclusion criteria

✓. Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their acne scarring or wrinkles.
✓. Able to read, understand and voluntarily provide written Informed Consent.
✓. Able and willing to comply with the treatment/follow-up schedule and requirements.
✓. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.

Exclusion criteria

✕. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
✕. Subjects with any implantable metal device in the treatment area
✕. Permanent implant in the treated area, such as metal plates and screws (excluding dental implants), or an injected chemical substance.
✕. Current or history of any kind of cancer, or dysplastic nevi
✕. Severe concurrent conditions, such as cardiac disorders.
✕. Pregnancy or intending to become pregnant during the study and nursing.
✕. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
✕. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.

What they're measuring

Overall Wrinkle Improvement Assessed by the Fitzpatrick Wrinkle and Elastosis Scale (FWES) at 12 Weeks Post-Final Treatment

Timeframe: 12 Weeks Post-Final Treatment

Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Post-Final Treatment

Timeframe: 12 Weeks Post-Final Treatment

Trial details

NCT IDNCT04057768

SponsorVenus Concept

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-03-03

Results submitted2021-02-03

View on ClinicalTrials.gov More Acne Scars - Mixed Atrophic and Hypertrophic trials

Who can participate

Age range22 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.

Inclusion criteria

✓. Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their acne scarring or wrinkles.
✓. Able to read, understand and voluntarily provide written Informed Consent.
✓. Able and willing to comply with the treatment/follow-up schedule and requirements.
✓. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.

Exclusion criteria

✕. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
✕. Subjects with any implantable metal device in the treatment area
✕. Permanent implant in the treated area, such as metal plates and screws (excluding dental implants), or an injected chemical substance.
✕. Current or history of any kind of cancer, or dysplastic nevi
✕. Severe concurrent conditions, such as cardiac disorders.
✕. Pregnancy or intending to become pregnant during the study and nursing.
✕. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
✕. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.

What they're measuring

Overall Wrinkle Improvement Assessed by the Fitzpatrick Wrinkle and Elastosis Scale (FWES) at 12 Weeks Post-Final Treatment

Timeframe: 12 Weeks Post-Final Treatment

Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Post-Final Treatment

Timeframe: 12 Weeks Post-Final Treatment