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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-, 3- and 6-months after treatment
Awards & highlights
Summary
This trial found that fractional radiofrequency was safe and effective in reducing surgical scarring.
Who is the study for?
This trial is for healthy women aged 21-75 looking to prevent surgical scars. Participants must avoid sun exposure on the treatment area, use reliable birth control, and not be pregnant or nursing. Exclusions include cancer history, severe conditions like heart disorders, skin issues in the treatment area, certain medications including isotretinoin within six months, metal implants near the treatment site, uncontrolled diabetes, bleeding disorders, pacemakers or similar devices.
What is being tested?
The study tests the safety and effectiveness of Fractional Radiofrequency in reducing scar formation after surgery. It's a preventive pre-treatment aimed at minimizing scarring for those undergoing surgical procedures.
What are the potential side effects?
While specific side effects are not listed here, fractional radiofrequency treatments may typically cause temporary redness, swelling at the treated area or changes in pigmentation. There could also be a risk of burns if not done correctly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-, 3- and 6-months after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-, 3- and 6-months after treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Independent blinded assessment
Principle Investigator (PI) evaluation of the scar(s)
Secondary study objectives
Colorimetry
Histological Assessment
Scar Morphology
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
All enrolled subjects will undergo breast reduction or breast mastectomy in which scar assessment will be made after pre-surgical treatment in a split-body design, involving a single treatment of RF application to one side of the surgical area(s) within 24 hours prior to the procedure. The subject will act as their own control, where one surgical area will be treated, and the other will not be and will act as the control. Tissue samples will be biopsied from RF treated skin, as well as non-treated skin, at follow up visits. The samples will be used for histological evaluation to assess tissue structure and regeneration following surgery.
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Who is running the clinical trial?
Venus ConceptLead Sponsor
34 Previous Clinical Trials
1,304 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a permanent implant like metal plates or screws in the treated area.I have or had cancer or abnormal moles.I have not used tanning beds, creams, or been excessively sun-tanned in the last two weeks.My diabetes or other hormone-related condition is not well-managed.I am a healthy woman aged 21-75 looking to prevent surgical scars.I haven't taken isotretinoin in the last 6 months or my doctor agrees it's okay.I have active skin conditions like sores or eczema in the treatment area.My immune system is weakened due to a condition like HIV or medication.I am willing to keep the treatment area out of direct sunlight during the study.I have a bleeding disorder or I'm taking blood thinners.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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