Clinical trial NCT03898830: Eon™ FR Clinical Study Protocol 1064
Official title: A Prospective, Controlled, Standardized, Multi-center, Single-treatment, Single-arm Evaluation of the Eon™ FR 1064 nm Device to Reduce Abdominal Fat With a 12-week Observation Interval to Assess Safe Fat Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat Disorder
Keywords: Adipose tissue, abdominal
Lead sponsor: Dominion Aesthetic Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-02
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Photographic Evaluations as a Measure of Effectiveness
timeFrame: 12 weeks
Secondary outcomes:
measure: Circumferential Measurements to Evaluate Reduction in Adipose Layer Thickness
timeFrame: 12 weeks
measure: Ultrasound Measurement to Evaluate Reduction in Adipose Layer Thickness
timeFrame: 12 weeks
measure: Subject Questionnaire to determine Subject Satisfaction
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser & Skin Surgery Center of Northern
state: California
city: Altamonte Springs
country: United States
facility: Fiala Aesthetics
state: Florida
city: Miami
country: United States
facility: Miami Dermatology & Laser Research
state: Florida
Study officials:
References: