Fat Disorder
Conditions
Keywords
Adipose tissue, abdominal
Brief summary
This study evaluates the treatment of subjects with the eon™ FR 1064 nm device in a single session to thermally induce apoptosis in adipose tissue.
Detailed description
This study evaluates the treatment of subjects between 18-60 with the eon™ FR 1064 nm device in a single session to thermally induce apoptosis in adipose tissue in the abdomen.
Interventions
DEVICEeon™ FR 1064 nm device
The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser.
Sponsors
Dominion Aesthetic Technologies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index (BMI) of 30 kg/m2 or less. * Healthy male or female between the ages of 21 and 60. * Had, at least 25 mm thickness adipose tissue on abdomen. * Able to read, understand and sign the Informed Consent Form (ICF). * Willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions. * Willing to have limited sun exposure for the duration of the study, including the follow-up period. * Willing to have photographs and ultrasound measurements taken of the treated area, which could be used de-identified in evaluations and could be used de-identified in presentations and/or publications. * Female subjects were either post-menopausal, surgically sterilized, or used a medically acceptable form of birth control during the entire course of the study. * Female subjects with child bearing potential were willing to take a urine pregnancy test and the result must be negative. * Agreed to maintain their current diet and exercise habits and not be specifically trying to lose weight.
Exclusion criteria
* Aesthetic fat reduction procedure in the treatment area within the previous year. * Age less than 21 or greater than 60 years old. * Female subject pregnant or planning to become pregnant during the study duration, * Had an infection, dermatitis or a rash in the treatment area. * Had tattoos or jewelry in the treatment area. * Had a history of keloid scarring, hypertrophic scarring or of abnormal wound healing. * Had a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications. * Had a history of a known bleeding disorder. * Had a known photosensitivity to the study laser wavelength, history of ingesting. medications known to induce photosensitivity, or history of seizure disorders due to light. * Had known collagen, vascular disease or scleroderma. * Underwent a surgery or procedure in the treatment area within 6 months of treatment, which is still healing. * Had underwent a fat reduction procedure in the treatment area within the past 12 months. * Had a significant concurrent illness, such as insulin-dependent diabetes, peripheral vascular disease or peripheral neuropathy. * Underwent systemic chemotherapy for the treatment of cancer. * Used gold therapy for disorders such as rheumatologic disease or lupus. * Participated in a study of another device or drug within three months prior to enrollment or during the study. * As per the investigator's discretion, the subject had any physical or mental condition which might make it unsafe for the subject to participate in this study. * Concurrent use of steroids or secondary rheumatoid drugs. * Prior liposuction or a tummy tuck in the study area.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Photographic Evaluations as a Measure of Effectiveness | 12 weeks | Photographs of the treatment area will be obtained at baseline and 12 weeks post treatment and be evaluated by blinded independent readers to correctly identify pre-treatment (baseline) photographs compared to 12 weeks post treatment photographs in order to determine effectiveness of device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Circumferential Measurements to Evaluate Reduction in Adipose Layer Thickness | 12 weeks | Circumferential measurements of the treatment area will be completed and evaluated in comparison to the baseline results to determine the reduction in adipose layer thickness. |
| Ultrasound Measurement to Evaluate Reduction in Adipose Layer Thickness | 12 weeks | Ultrasound of the treatment area will be performed and evaluated in comparison to the baseline results to determine the reduction in adipose layer thickness. |
| Subject Questionnaire to determine Subject Satisfaction | 12 weeks | Subject Questionnaires will be completed by subjects at the end of study to determine the subject satisfaction with procedure. |
Countries
United States
Outcome results
None listed