Venus Bliss for Adipose Tissue Atrophy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Batra Dermatology, Santa Monica, CA
Adipose Tissue Atrophy+1 More
Venus Bliss - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a non-invasive treatment can reduce fat in the abdomen and flanks.

See full description

Eligible Conditions

  • Adipose Tissue Atrophy

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Venus Bliss will improve 1 primary outcome and 2 secondary outcomes in patients with Adipose Tissue Atrophy. Measurement will happen over the course of week 1.

week 1
Subject assessment of discomfort: Wong Baker scale
week 30
Photographic evaluation
Subject satisfaction: 5-Point Likert Subject Satisfaction Scale

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Group

Subject treatment group
1 of 1
Experimental Treatment

This trial requires 60 total participants across 1 different treatment group

This trial involves a single treatment. Venus Bliss is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Subject treatment group
Device
Treatment group receiving up to 4 diode treatments and up to 8 RF treatments.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venus Bliss
2019
N/A
~20

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 30
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 30 for reporting.

Closest Location

Batra Dermatology - Santa Monica, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
1. Able to read, understand and voluntarily provide written informed consent. 2. Healthy male or female, ≥ 18 years of age seeking treatment for unwanted fat in the flanks.
3. BMI score is less than 35. 4. Agree to not making any major changes in their diet or lifestyle during the course of the study.
5. Able and willing to comply with the treatment/follow-up schedule and requirements.
6. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline.

Patient Q&A Section

What are the signs of atrophy?

"Signs of atrophy are a number of physical changes that include loss of muscle mass, enlargement of fat around the body, and a loss of fat tissue around the face and shoulders. These changes can be viewed in a body mass index and/or waist circumference ratio." - Anonymous Online Contributor

Unverified Answer

What causes atrophy?

"The cause of atrophy in the brain is not known, but brain weight increases may be from growth hormones produced in the hypothalamus or from cellular hyperplasia in the basal ganglia.\n" - Anonymous Online Contributor

Unverified Answer

Can atrophy be cured?

"It appears that atrophy can be reduced by lifestyle modifications and by orchiectomy. Atrophy is also a reliable outcome measurement that can be used in the management of men." - Anonymous Online Contributor

Unverified Answer

What are common treatments for atrophy?

"Many people who are treated with laser-assisted resurfacing show no measurable improvement at 12-month follow-up in objective measures or subjective signs of facial rejuvenation. Subjective scores and patient satisfaction also do not change in people who are treated with a second laser-assisted resurfacing session. Findings from a recent study are inconsistent with current consensus that LA-RA is an effective face rejuvenation treatment. In combination with clinical experience, the objective and subjective findings of this pilot study do reinforce the growing literature on the lack of effectiveness of laser-assisted resurfacing as a face rejuvenation procedure." - Anonymous Online Contributor

Unverified Answer

What is atrophy?

"Atrophy of the substantia nigra can be demonstrated on cross-sectional imaging of the midbrain using T2-weighted and FLAIR sequences. Atrophy can also be demonstrated using MRI sequences such as 3D 3T MRI and in an elegant, and minimally invasive, imaging technique called high angular resolution T2*-weighted imaging." - Anonymous Online Contributor

Unverified Answer

How many people get atrophy a year in the United States?

"About 4.4 million individuals a year in the United States are diagnosed with Atrophy. This makes up about 22.9% of US adults. However, it's important to note that for males, the rate is much higher, and that the rate of Atrophy and Osteoporosis is very similar. If someone was to have both Atrophy and Osteoporosis, The National Osteoporosis Foundation estimates that it would happen every 8 years. This gives an estimate for both genders of about 8.7 million people a year in the United States." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for atrophy?

"Individuals with atrophy have a higher mortality and disability rate and are two times more likely to be unemployed than those without atrophy. These people are more likely to live alone, have a higher heart rate, a lower body mass index, higher blood pressure, and they are more likely to need assistance from others after a stroke. It is important for clinicians to carefully consider the physical symptoms of atrophy and how to treat it for these patients." - Anonymous Online Contributor

Unverified Answer

How serious can atrophy be?

"We have shown that atrophy is common, and patients on immunosuppressive therapy should be screened for atrophy. The magnitude of atrophy as well as the presence of visceral fat were independent risk factors predicting the occurrence of acute rejection. Results from a recent paper have important implications for the timing of elective steroid tapering in patients undergoing renal transplantation." - Anonymous Online Contributor

Unverified Answer

Does venus bliss improve quality of life for those with atrophy?

"Patients who received the venus Bliss product reported significant increases in QoL over placebo, especially by baseline. The Venus Bliss product appears to have beneficial effects for women with moderate to severe vulvar atrophy." - Anonymous Online Contributor

Unverified Answer

Does atrophy run in families?

"Atrophy of the cornea has an autosomal-residual pattern in the family-of-inheritance: the parent who may be free of symptoms has no offspring with atrophy while a sibling who has atrophy has an increased probability of producing an offspring with atrophy. Such a pattern may be due to a common pathogenic factor shared by the parent and child, or to a common environmental effect on the child. In the latter case, the prevalence of atrophy might vary with location." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving venus bliss?

"There have not been other venus bliss trials and therefore it is difficult to predict if other studies will confirm this phenomenon. However, venus bliss can be experienced in other areas of the brain and other parts of the body." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of venus bliss?

"Many women who [take the drug] report experiencing varying degrees of venus effects, often resulting in moderate to severe effects. These side effects are manageable and have usually subsided after treatment ceases or [relapses]. The side effects of venus bliss can be minimized through appropriate dose adjustment on an individual’s basis. The common side effects of venus bliss are usually mild, reversible, and generally improve with the gradual cessation of use." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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