RECRUITING

Fractional Radiofrequency for Reduction of Surgical Scar Formation

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Safety and Efficacy of Fractional Radiofrequency for the Reduction of Surgical Scar Formation

Official Title

Safety and Efficacy of Fractional Radiofrequency for the Reduction of Surgical Scar Formation

Quick Facts

Study Start:2023-09-01

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05897723

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 75 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Healthy, female subjects 21-75 years of age who are seeking pre-treatment for the prevention of surgical scars. 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. Willing to avoid direct sunlight to the treatment area for the duration of the study. 5. 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.	1. Subjects with any implantable metal device in the treatment area 2. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant). 3. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance. 4. Current or history of any kind of cancer, or dysplastic nevi. 5. Severe concurrent conditions, such as cardiac disorders. 6. Pregnancy or intending to become pregnant during the study and nursing. 7. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications. 8. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime. 9. Poorly controlled endocrine disorders, such as diabetes. 10. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. 11. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin. 12. History of bleeding coagulopathies, or use of anticoagulants. 13. Use of isotretinoin (Accutane®) within six months prior to treatment or at physician discretion. 14. Treating over tattoo or permanent makeup. 15. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.

Inclusion Criteria

Exclusion Criteria

1. Healthy, female subjects 21-75 years of age who are seeking pre-treatment for the prevention of surgical scars.
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. Willing to avoid direct sunlight to the treatment area for the duration of the study.
5. 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.

1. Subjects with any implantable metal device in the treatment area
2. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
3. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
4. Current or history of any kind of cancer, or dysplastic nevi.
5. Severe concurrent conditions, such as cardiac disorders.
6. Pregnancy or intending to become pregnant during the study and nursing.
7. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
8. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
9. Poorly controlled endocrine disorders, such as diabetes.
10. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
11. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
12. History of bleeding coagulopathies, or use of anticoagulants.
13. Use of isotretinoin (Accutane®) within six months prior to treatment or at physician discretion.
14. Treating over tattoo or permanent makeup.
15. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.

Contacts and Locations

Study Contact

Andrea Biro, MSc.

CONTACT

8889070115

abiro@venusconcept.com

Matthew Gronski, PhD

CONTACT

8889070115

mgronski@venusconcept.com

Study Locations (Sites)

UT Southwestern Medical Center, Department of Plastic Surgery

Dallas, Texas, 75390

United States

Collaborators and Investigators

Sponsor: Venus Concept

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-01

Study Completion Date2024-12

Study Record Updates

Study Start Date2023-09-01

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

Surgical Incision