Back to resultsEvaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology
Primary Purpose
Skin Laxity, Muscle Contracture
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DMA treatment
Sponsored by
About this trial
This is an interventional treatment trial for Skin Laxity
Eligibility Criteria
Inclusion Criteria:
- Subject read, understood and signed the Consent Form
- Healthy male or female aged 25-45 years,
- Fitzpatrick skin type 1-6
- Subject is capable of reading, understanding and following instructions of the procedure to be applied.
- Subject is able and willing to comply with the treatment.
- Women of child-bearing potential are required to use two forms of reliable methods of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, NuvaRing, partner with vasectomy, Implanon or other FDA-approved devices, or abstinence) during the course of the study.
Exclusion Criteria:
General
- Subject is female who is pregnant, lactating, or plans to become pregnant during the study period or had given birth less than 6 months ago.
Concurrent participation in any other study.
Specific to the treatment and treatment area
- Subject has a pacemaker or internal defibrillator, implanted neurostimulators or any other internal electric device or patient who had an implant in the past.
- Subject has metal or other implants in the treatment area (Not including dental fillings, implants and crowns).
- Subject has significant concurrent skin conditions affecting areas to be treated such as sores, bleeding, skin fragility, eczema or psoriasis.
Subject has burned, blistered, irritated, or sensitive skin due to excessive fresh tanning in areas to be treated or is unlikely to refrain from excessive tanning during the study.
Other treatments
- Subject has used oral isotretinoin (Accutane or Roaccutan®) within 6 months prior to study enrollment or plans use during the course of the study.
Subject has used topical retinoids in past 1 month
Medical conditions/ use of medication
- Subject has current or history of systemic cancer; premalignant skin lesion or skin concern treatment area.
- Subject has severe concurrent conditions such as epilepsy, autoimmune, pulmonary or cardiac disorders.
- Subject has poorly controlled endocrine disorders such as diabetes.
- Subject has an impaired immune system due to immunosuppressive diseases such as HIV or AIDS, or use of immunosuppressive medications.
- Subject has history of collagen disorders, keloid formation or abnormal wound healing.
- Subject takes or has taken medications, herbal preparations, food supplements or vitamins that might cause fragile skin or impaired skin healing
- Subject has used oral steroids in past 6 months
- Subject has used topical steroids in past 3 months
- Subject has history of bleeding coagulopathies or use of anticoagulants.
- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen containing agents) one week before and after each treatment session prior to treatment
- Subject has mental disorders that in the opinion of the Investigator would be interfere with ability to comply with the study requirements.
- Subject has any other medical condition that in the opinion of the Investigator warrants exclusion from this study
Sites / Locations
- Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Treatment in the face area
Treatment in the buttocks area
Treatment in the abdominal region
Arm Description
5 female subjects will receive treatment in the face area
5 female subjects will receive treatment in the buttocks area
5 male subjects will receive treatment in the abdominal region
Outcomes
Primary Outcome Measures
To evaluate the immediate effects and safety of DMATM novel muscle stimulation technology on the face, buttocks, and abdominal regions: GAI scale
Efficacy of the treatment will be based on before and after photography. Efficacy will be established by the Global Aesthetic Improvement scale (GAI) completed by the Principal investigator. Success is defined as an improvement of at least 1 point on the GAI scale assessed by the investigator, as compared to baseline.
Global Aesthetic Improvement (GAI) Scale:
Worse (0), No change (1), Somewhat improved (2), Moderately improved (3), Very Much Improved (4)
Secondary Outcome Measures
To evaluate procedure-related skin safety, subject discomfort, and subject satisfaction: questionnaire
The secondary endpoint will be assessed by the following:
• Subject satisfaction questionnaire
Safety End-Points:
Immediate skin response (erythema, edema, etc.) following each treatment as evaluated by the investigator.
Subject assessment of pain and discomfort associated with treatments using a Pain Visual Analogue Scale (VAS), were 0 is "no pain" and 10 is "intolerable pain"
Skin safety throughout the study as determined by the investigator by examining the post-treatment occurrences of complications and adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04296201
Brief Title
Evaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology
Official Title
Evaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
February 15, 2021 (Actual)
Study Completion Date
February 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumenis Be Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A total of at least 15 and up to 17 healthy subjects at a single site, aged 25-45 years old, who wish to receive a lifting effect and improved muscle definition, will be included in the study.
The procedure will include treatments with the Legend Pro™ DMA™ technology. Photos will be obtained at pre-defined time points throughout the study.
Detailed Description
Single center, prospective, open Label with Before & After Study Design. This study is designed to evaluate the immediate efficacy and safety of Legend Pro™'s DMA™ muscle stimulation technology. Treatment areas will include the face, buttocks, or abdominal region. Each subject will receive 1 treatment with no follow-up visits required. Interim assessment will be held after half of the study population has received treatment.
The study population will be divided into three arms as follows:
5 female subjects will receive treatment in the face area
5 female subjects will receive treatment in the buttocks area
5 male subjects will receive treatment in the abdominal region
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity, Muscle Contracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment in the face area
Arm Type
Experimental
Arm Description
5 female subjects will receive treatment in the face area
Arm Title
Treatment in the buttocks area
Arm Type
Experimental
Arm Description
5 female subjects will receive treatment in the buttocks area
Arm Title
Treatment in the abdominal region
Arm Type
Experimental
Arm Description
5 male subjects will receive treatment in the abdominal region
Intervention Type
Device
Intervention Name(s)
DMA treatment
Intervention Description
Each arm will receive the DMA treatment in a specific area on the body to observe immediate effect.
Primary Outcome Measure Information:
Title
To evaluate the immediate effects and safety of DMATM novel muscle stimulation technology on the face, buttocks, and abdominal regions: GAI scale
Description
Efficacy of the treatment will be based on before and after photography. Efficacy will be established by the Global Aesthetic Improvement scale (GAI) completed by the Principal investigator. Success is defined as an improvement of at least 1 point on the GAI scale assessed by the investigator, as compared to baseline.
Global Aesthetic Improvement (GAI) Scale:
Worse (0), No change (1), Somewhat improved (2), Moderately improved (3), Very Much Improved (4)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To evaluate procedure-related skin safety, subject discomfort, and subject satisfaction: questionnaire
Description
The secondary endpoint will be assessed by the following:
• Subject satisfaction questionnaire
Safety End-Points:
Immediate skin response (erythema, edema, etc.) following each treatment as evaluated by the investigator.
Subject assessment of pain and discomfort associated with treatments using a Pain Visual Analogue Scale (VAS), were 0 is "no pain" and 10 is "intolerable pain"
Skin safety throughout the study as determined by the investigator by examining the post-treatment occurrences of complications and adverse events.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject read, understood and signed the Consent Form
Healthy male or female aged 25-45 years,
Fitzpatrick skin type 1-6
Subject is capable of reading, understanding and following instructions of the procedure to be applied.
Subject is able and willing to comply with the treatment.
Women of child-bearing potential are required to use two forms of reliable methods of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, NuvaRing, partner with vasectomy, Implanon or other FDA-approved devices, or abstinence) during the course of the study.
Exclusion Criteria:
General
Subject is female who is pregnant, lactating, or plans to become pregnant during the study period or had given birth less than 6 months ago.
Concurrent participation in any other study.
Specific to the treatment and treatment area
Subject has a pacemaker or internal defibrillator, implanted neurostimulators or any other internal electric device or patient who had an implant in the past.
Subject has metal or other implants in the treatment area (Not including dental fillings, implants and crowns).
Subject has significant concurrent skin conditions affecting areas to be treated such as sores, bleeding, skin fragility, eczema or psoriasis.
Subject has burned, blistered, irritated, or sensitive skin due to excessive fresh tanning in areas to be treated or is unlikely to refrain from excessive tanning during the study.
Other treatments
Subject has used oral isotretinoin (Accutane or Roaccutan®) within 6 months prior to study enrollment or plans use during the course of the study.
Subject has used topical retinoids in past 1 month
Medical conditions/ use of medication
Subject has current or history of systemic cancer; premalignant skin lesion or skin concern treatment area.
Subject has severe concurrent conditions such as epilepsy, autoimmune, pulmonary or cardiac disorders.
Subject has poorly controlled endocrine disorders such as diabetes.
Subject has an impaired immune system due to immunosuppressive diseases such as HIV or AIDS, or use of immunosuppressive medications.
Subject has history of collagen disorders, keloid formation or abnormal wound healing.
Subject takes or has taken medications, herbal preparations, food supplements or vitamins that might cause fragile skin or impaired skin healing
Subject has used oral steroids in past 6 months
Subject has used topical steroids in past 3 months
Subject has history of bleeding coagulopathies or use of anticoagulants.
Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen containing agents) one week before and after each treatment session prior to treatment
Subject has mental disorders that in the opinion of the Investigator would be interfere with ability to comply with the study requirements.
Subject has any other medical condition that in the opinion of the Investigator warrants exclusion from this study
Facility Information:
Facility Name
Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology
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