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

Primary Purpose

Fat Atrophy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

1060nm diode laser

About this trial

This is an interventional treatment trial for Fat Atrophy focused on measuring abdomen, adipose, fat

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

able to read, understand and voluntarily provide written informed consent
healthy male or female > 18 years of age seeking treatment for unwanted fat in the abdomen
BMI score is less then 30
agree to not making any major changes in their diet or lifestyle during the course of the study
able and willing to comply with the treatment / follow up schedule and requirements
women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrolment and for the duration of the study, have a negative urine pregnancy test baseline

Exclusion Criteria:

pregnant in the last 3 months intending to become pregnant, postpartum or nursing in the last 6 months
any previous liposuction / lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months
history of immunosuppression / immune deficiency disorders including AIDS and HIV infection, or use of immunosuppressive medications, 6 month prior to and during the course of the study
History of hyperlipidemia, diabetes, hepatitis, blood coagulopathy or excessive bleeding
Use of antiplatelet medications (81 mg of acetylsalicylic acid daily is permitted), anticoagulants, thrombocytes or any-inflammatory medications within 2 weeks of treatment
Having a history of skin cancer or any other cancer in the area to be treated, including presence of malignant or pre-malignant pigmented lesions
Having a permanent implant in the treatment area such as a metal plate or injected chemical substance such as silicone pr parenteral gold therapy (gold sodium thiomalate)
Use of medications, herbs or food supplements and vitamins known to induce photosensitivity to light exposure at the wavelength used history of photosensitivity disorder
Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections
Tattoos in the treatment area
Poor quality skin (laxity)
Abdominal wall, muscular abnormality or hernia on physical examination
Unstable weight within the last 6 months (+ or - 3% weight change in the prior six months)
Participation in another clinical study involving the same anatomical areas within the last 6 months
History of keloid and hypertrophic scar formation or poor wound healing in the treatment area
As per the investigators discretion any physician or mental condition which may make it unsafe for the subject to participate

Sites / Locations

Laser and Skin Surgery Center of Northern California
Southwestern Medical Center Department of Plastic Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment subjects

Arm Description

Single group of subjects which will have the treatment of a 1060nm diode laser administered to them.

Outcomes

Primary Outcome Measures

Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators

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

Secondary Outcome Measures

Change in Fat Thickness

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

Subject Satisfaction

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.

Treatment Pain

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.

Full Information

NCT ID

NCT03756350

First Posted

November 26, 2018

Last Updated

June 12, 2023

Sponsor

Venus Concept

1. Study Identification

Unique Protocol Identification Number

NCT03756350

Brief Title

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

Official Title

Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser for Non-invasive Fat Reduction of the Abdomen

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

November 14, 2018 (Actual)

Primary Completion Date

July 2, 2019 (Actual)

Study Completion Date

July 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Venus Concept

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

Open-label baseline controlled evaluator-blind multi-centre study 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 which takes approximately 25 minutes. Subjects will be followed at six and twelve weeks post treatment. Twelve week outcomes will be compared to baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fat Atrophy

Keywords

abdomen, adipose, fat

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

Blinded reviewer will evaluate the pre and post photos

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment subjects

Arm Type

Experimental

Arm Description

Single group of subjects which will have the treatment of a 1060nm diode laser administered to them.

Intervention Type

Device

Intervention Name(s)

1060nm diode laser

Intervention Description

Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.

Primary Outcome Measure Information:

Title

Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators

Description

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

Time Frame

Week 12 vs baseline

Secondary Outcome Measure Information:

Title

Change in Fat Thickness

Description

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

Time Frame

week 12

Title

Subject Satisfaction

Description

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.

Time Frame

Week 12

Title

Treatment Pain

Description

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.

Time Frame

Week 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: able to read, understand and voluntarily provide written informed consent healthy male or female > 18 years of age seeking treatment for unwanted fat in the abdomen BMI score is less then 30 agree to not making any major changes in their diet or lifestyle during the course of the study able and willing to comply with the treatment / follow up schedule and requirements women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrolment and for the duration of the study, have a negative urine pregnancy test baseline Exclusion Criteria: pregnant in the last 3 months intending to become pregnant, postpartum or nursing in the last 6 months any previous liposuction / lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months history of immunosuppression / immune deficiency disorders including AIDS and HIV infection, or use of immunosuppressive medications, 6 month prior to and during the course of the study History of hyperlipidemia, diabetes, hepatitis, blood coagulopathy or excessive bleeding Use of antiplatelet medications (81 mg of acetylsalicylic acid daily is permitted), anticoagulants, thrombocytes or any-inflammatory medications within 2 weeks of treatment Having a history of skin cancer or any other cancer in the area to be treated, including presence of malignant or pre-malignant pigmented lesions Having a permanent implant in the treatment area such as a metal plate or injected chemical substance such as silicone pr parenteral gold therapy (gold sodium thiomalate) Use of medications, herbs or food supplements and vitamins known to induce photosensitivity to light exposure at the wavelength used history of photosensitivity disorder Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections Tattoos in the treatment area Poor quality skin (laxity) Abdominal wall, muscular abnormality or hernia on physical examination Unstable weight within the last 6 months (+ or - 3% weight change in the prior six months) Participation in another clinical study involving the same anatomical areas within the last 6 months History of keloid and hypertrophic scar formation or poor wound healing in the treatment area As per the investigators discretion any physician or mental condition which may make it unsafe for the subject to participate

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suzanne Kilmer, MD

Organizational Affiliation

Skin and Laser Surgery Center of Northern California

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jeffery Kenkel, MD

Organizational Affiliation

UT Southwestern

Official's Role

Principal Investigator

Facility Information:

Facility Name

Laser and Skin Surgery Center of Northern California

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

Facility Name

Southwestern Medical Center Department of Plastic Surgery

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28103642

Citation

Decorato JW, Chen B, Sierra R. Subcutaneous adipose tissue response to a non-invasive hyperthermic treatment using a 1,060 nm laser. Lasers Surg Med. 2017 Jul;49(5):480-489. doi: 10.1002/lsm.22625. Epub 2017 Jan 19.

Results Reference

result

PubMed Identifier

28902034

Citation

Katz B, Doherty S. Safety and Efficacy of a Noninvasive 1,060-nm Diode Laser for Fat Reduction of the Flanks. Dermatol Surg. 2018 Mar;44(3):388-396. doi: 10.1097/DSS.0000000000001298.

Results Reference

result

PubMed Identifier

21779417

Citation

McBean JC, Katz BE. Laser lipolysis: an update. J Clin Aesthet Dermatol. 2011 Jul;4(7):25-34. No abstract available.

Results Reference

result

PubMed Identifier

28095532

Citation

Schilling L, Saedi N, Weiss R. 1060 nm Diode Hyperthermic Laser Lipolysis:The Latest in Non-Invasive Body Contouring. J Drugs Dermatol. 2017 Jan 1;16(1):48-52.

Results Reference

result

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

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