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N/A

Laser and Radio Frequency Treatment for Skin Tightening

N/A
Waitlist Available
Led By Jeffrey Kenkel, MD
Research Sponsored by Venus Concept
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 day 1, day 7, day 14, day 20-30 post-treatment
Awards & highlights

Study Summary

This trial is testing whether a laser and radio frequency treatment is safe and effective for skin conditions.

Who is the study for?
This trial is for women who are post-menopausal, surgically sterilized, or using birth control. They must be planning an abdominoplasty surgery and agree to have their excised tissue tested. Participants should have Fitzpatrick skin type I-V and commit to the treatment schedule and care instructions. Exclusions include pregnancy, recent surgeries in the area, significant skin conditions, immune disorders, cancer history in the treated area, excessive tanning habits, participation in other trials recently or certain medication use.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of a 1060nm diode laser combined with radio frequency on patients before they undergo abdominoplasty surgery. The effects will be analyzed through histological (tissue structure) and molecular analysis to see how well it works for reducing adipose tissue atrophy.See study design
What are the potential side effects?
Potential side effects may include reactions similar to those from heat-based treatments such as redness or swelling at the treatment site. There might also be risks associated with laser treatments like temporary discomfort or changes in skin pigmentation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 7, day 14, day 20-30 post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 7, day 14, day 20-30 post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in collagen as determined by histology on biopsied tissues
Changes in elastin as determined by histology on biopsied tissues
Changes in hyaluronic acid as determined by histology on biopsied tissues
Secondary outcome measures
Changes in collagen as a result of treatment measured by quantification of gene expression
Changes in elastin as a result of treatment measured by quantification of gene expression
Changes in hyaluronic acid as a result of treatment measured by quantification of gene expression
+1 more

Trial Design

3Treatment groups
Active Control
Group I: Diode Laser Treatment OnlyActive Control1 Intervention
Group 1: Patient 1- Laser Only This patient will present 20+, 14, 7, and 1 days prior to his/her scheduled abdominoplasty. Between 20 and 30 days prior, the patient will receive the first laser treatment on the 20+ day site 1. 14 days prior, the patient will receive laser treatment on the 14 day site 2. 7 days prior, the patient will receive laser treatment on the 7 day site 3. 1 day prior to the scheduled abdominoplasty, the patient will receive laser treatment on the 24 hour site 4.
Group II: Diode Laser and RadioFrequency TreatmentActive Control1 Intervention
This patient will present 14 days and 7 days prior to his/her scheduled abdominoplasty. 14 days prior, the patient will be treated at site 1 with the laser and radiofrequency and site 3 with the laser only. 7 days prior, the patient will be treated at site 2 with the laser and radiofrequency and site 4 with the laser only.
Group III: Multiple Diode TreatmentsActive Control1 Intervention
These patients will present for three treatments, each four weeks apart, with the abdominoplasty scheduled four weeks following the last laser treatment. These patients will receive laser treatment every four weeks for twelve weeks on the sites labelled Multiple Tx below (sites 1 and 2) on Days -90, -60, and -30 prior to abdominoplasty. At the final treatment (Day -30), two additional diodes will be placed on the sites labelled Single Tx below (sites 3 and 4). 4 diodes total will be used at this visit. Four weeks following this last treatment, the scheduled abdominoplasty will be performed and the pannus containing the treated tissue will be excised.

Find a Location

Who is running the clinical trial?

Venus ConceptLead Sponsor
34 Previous Clinical Trials
1,359 Total Patients Enrolled
1 Trials studying Adipose Tissue Atrophy
65 Patients Enrolled for Adipose Tissue Atrophy
University of TexasOTHER
186 Previous Clinical Trials
142,470 Total Patients Enrolled
Matthew Gronski, PhDStudy DirectorVenus Concept
4 Previous Clinical Trials
261 Total Patients Enrolled

Media Library

Venus Bliss (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT04616898 — N/A
Adipose Tissue Atrophy Research Study Groups: Diode Laser Treatment Only, Diode Laser and RadioFrequency Treatment, Multiple Diode Treatments
Adipose Tissue Atrophy Clinical Trial 2023: Venus Bliss Highlights & Side Effects. Trial Name: NCT04616898 — N/A
Venus Bliss (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04616898 — N/A

Frequently Asked Questions

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

Is there still an opportunity to take part in this research endeavor?

"Unfortunately, the data hosted on clinicaltrials.gov suggests that this medical study is not currently seeking candidates at this time. The trial was initially posted on July 1st 2020 and its last update occurred 25th April 2022. However, there are 185 other trials accepting applicants as we speak."

Answered by AI

What is the hoped-for result of this experiment?

"The primary aim of this trial, measured on Day 1, 7, 14 and 20-30 post treatment is to assess the impact of treatment on collagen formation as determined by histology. Secondary outcomes include an assessment of elastin gene expression with biopsies taken prior to and after intervention; quantification of immune response related gene expression through biopsy sampling before and after therapy; and determination of changes in collagen levels via gene expression analysis from pre/post-treatment tissue samples."

Answered by AI

Who qualifies as an appropriate participant for this research?

"Applicants who wish to join this clinical trial must have adiposis dolorosa and be between the ages of 21-60. A maximum of 9 participants are being accepted for the study."

Answered by AI

Is the participant pool of this investigation inclusive of individuals aged 85 or above?

"The requirements for entering this medical trial state that the minimum age is 21 and no participant can be older than 60 years old."

Answered by AI
~2 spots leftby Mar 2025