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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, and optional 9 months post last treatment visit.
Awards & highlights
No Placebo-Only Group
Summary
"This trial will test if fractional radiofrequency is safe and effective for treating moderate to severe acne vulgaris."
Who is the study for?
This trial is for 18-25 year-olds with moderate to severe facial acne, defined by specific criteria. Participants must be on tetracycline antibiotics and off other acne treatments for set periods before the study. They should have a balanced acne condition on both sides of their face and agree to birth control if applicable.
What is being tested?
The trial tests the safety and effectiveness of fractional radiofrequency (RF) using triLift/Legend Pro+ system in treating moderate to severe acne vulgaris compared to standard treatments.
What are the potential side effects?
Potential side effects may include temporary redness, swelling, or irritation at the treatment site due to RF energy exposure. These are common reactions following RF procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, and optional 9 months post last treatment visit.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, and optional 9 months post last treatment visit.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate the Efficacy of Fractional RF for the Treatment of Moderate to Severe Acne Vulgaris
Secondary study objectives
Overall Improvement of Acne
Subjective Satisfaction with the Treatment Results
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Open(self-controlled) split-face design study. Thirty participants will undergo the treatments on one side of the face (buccal area). Treatments will be randomized with combination antibiotic/ FRF therapy.
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Who is running the clinical trial?
Lumenis Be Ltd.Industry Sponsor
37 Previous Clinical Trials
1,383 Total Patients Enrolled
1 Trials studying Acne
13 Patients Enrolled for Acne
PollogenLead Sponsor
3 Previous Clinical Trials
109 Total Patients Enrolled
Yuri VinshtokStudy DirectorPollogen Ltd.
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