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Procedure

Single Arm for Acne

N/A

Recruiting

Research Sponsored by Pollogen

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

Study 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.Check my eligibility

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.See study design

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, and optional 9 months post last treatment visit. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate the Efficacy of Fractional RF for the Treatment of Moderate to Severe Acne Vulgaris

Secondary outcome measures

Overall Improvement of Acne

Subjective Satisfaction with the Treatment Results

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.

Do I qualify?Apply below to find out

Find a Location

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.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently enrolling participants for this medical study?

"Indeed, the details on clinicaltrials.gov affirm that this investigation is actively seeking participants. Initially shared on April 10, 2024, and last revised on the same date, this study aims to recruit 30 individuals from a single site."

Answered by AI

Am I eligible to participate in this medical study?

"Individuals aged between 18 and 25 years old with a diagnosis of acne are sought after to participate in this research endeavor. The study aims to recruit a total of 30 suitable candidates."

Answered by AI

What is the upper limit of participant enrollment for this medical study?

"Indeed, the details provided on clinicaltrials.gov highlight that this study is actively seeking individuals to participate. The trial was initially listed on April 10th, 2024 and most recently revised on the same date. It aims to enlist 30 patients at a single site for involvement."

Answered by AI

Is there an age requirement for participation in this study, specifically pertaining to individuals over 50 years old?

"Individuals between 18 and 25 years of age are the targeted demographic for this medical investigation. There are 17 studies catering to those under 18, and another 15 tailored towards individuals over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study on Using Radiofrequency to Treat Moderate to Severe Acne

2024. "Study on Using Radiofrequency to Treat Moderate to Severe Acne". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06315166.

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