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COMPLETEDNA

Clinical Evaluation of the Safety and Performance of FRF for the Treatment and Reduction of Acne Scarring

Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Acne Scarring

NCT04827680•Venus Concept

View on ClinicalTrials.gov

Summary

Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of acne scarring. The study will evaluate the progress of 20 subjects requesting treatment of acne scarring. The study will involve three treatments on both sides of the face with 3-5 week intervals between each treatment. Subjects will be followed at 6 and 12 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their acne scarring.
•2. Able to read, understand and voluntarily provide written Informed Consent.
•3. Able and willing to comply with the treatment/follow-up schedule and requirements.
•4. 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

•1. Implantable defibrillators, cardiac pacemakers, and other metal implants
•2. Subjects with any implantable metal device in the treatment area
•3. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
•4. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
•5. Current or history of any kind of cancer, or pre-malignant moles.
•6. Severe concurrent conditions, such as cardiac disorders.
•7. Pregnancy or intending to become pregnant during the study and nursing.
•8. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
•9. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only after a prophylactic regime has been followed for 2 weeks or longer prior to enrollment, or according to Investigator's discretion.
•10. Poorly controlled endocrine disorders, such as diabetes.
+10 more criteria

Locations (1)

Sadick Research Group

New York, New York, United States

Key Dates

Start Date

May 1, 2021

Primary Completion Date

June 13, 2022

Completion Date

June 13, 2022

Last Updated

October 4, 2023

Enrollment

ACTUAL participants

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Interventions

Venus Viva MD

DEVICE

The MIRIA Acne Scar Study

NCT05597267

Acne Scars - Mixed Atrophic and Hypertrophic

View study

COMPLETEDNA

Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring

NCT04606134

Acne Scars - Mixed Atrophic and Hypertrophic

View study

UNKNOWNNA

Microneedling With Topical Preparations in the Treatment of Atrophic Post-acne Scars

NCT05600075

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 4, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Evaluation of the Safety and Performance of FRF for the Treatment and Reduction of Acne Scarring

Inclusion Criteria

Exclusion Criteria

The MIRIA Acne Scar Study

Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring

Microneedling With Topical Preparations in the Treatment of Atrophic Post-acne Scars

Performance of PicoWayTM Picosecond Fractional Laser for Acne Scars