NCT03756350

Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser (Abdomen)

Completed NA Results posted Last updated 3 July 2023

What this trial tests

NA trial testing 1060nm diode laser in Fat Atrophy in 30 participants. Completed in 2 July 2019.

Timeline

14 November 2018

Primary endpoint
2 July 2019

2 July 2019

Quick facts

Lead sponsor	Venus Concept
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	14 November 2018
Primary completion	2 July 2019
Estimated completion	2 July 2019
Sites	2 locations across United States

Drugs / interventions tested

• 1060nm diode laser

Conditions studied

• Fat Atrophy — all drugs for Fat Atrophy →

Sponsor

Venus Concept

Who can join

18 and older, any sex, with Fat Atrophy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators Primary · Week 12 vs baseline

Photographic evaluation by independent blinded evaluators with correct identification of pre-treatment baseline images when compared to post-treatment images taken at 12 weeks

Group	Value	95% CI
Treatment Subjects	54

Change in Fat Thickness Secondary · week 12

Change in thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline

Group	Value	95% CI
Treatment Subjects	-9.8	± 1.56

Subject Satisfaction Secondary · Week 12

Subject satisfaction with treatment at 12 weeks after treatment using the 5-point Likert Subject Satisfaction Scale. A score of 4 is very satisfied and 0 is very unsatisfied.

Group	Value	95% CI
Treatment Subjects	2.9	± 0.85

Treatment Pain Secondary · Week 1

Subject assessment of discomfort and pain post treatment as measured using the Wong Baker Faces Scale, which is a 10 point scale with 10 being the worst pain ever and 0 being no pain.

Group	Value	95% CI
Treatment Subjects	2.6	± 1.6

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks following treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Subjects

Serious: 0/30 (0%)

Deaths: 0/30

Other adverse events (1 terms — click to expand)

Reaction	System	Treatment Subjects
Not visible, but palpable nodules	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT03756350 adverse events section.

Sponsor's own description

This study is evaluating a 1060nm diode laser for non-invasive fat reduction of the abdomen. The study will enrolled up to 50 subjects requesting non-invasive lipolysis of the abdomen. Each subject will receive a single study treatment. Subjects will be followed at six and twelve weeks post treatment. Twelve week outcomes will be compared to baseline.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.