Evaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2020
CompletedFirst Posted
Study publicly available on registry
March 5, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2021
CompletedFebruary 17, 2021
February 1, 2021
6 months
March 2, 2020
February 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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)
6 months
Secondary Outcomes (1)
To evaluate procedure-related skin safety, subject discomfort, and subject satisfaction: questionnaire
6 months
Study Arms (3)
Treatment in the face area
EXPERIMENTAL5 female subjects will receive treatment in the face area
Treatment in the buttocks area
EXPERIMENTAL5 female subjects will receive treatment in the buttocks area
Treatment in the abdominal region
EXPERIMENTAL5 male subjects will receive treatment in the abdominal region
Interventions
Each arm will receive the DMA treatment in a specific area on the body to observe immediate effect.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lumenis Be Ltd.lead
Study Sites (1)
Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC
Charlotte, North Carolina, 28207, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2020
First Posted
March 5, 2020
Study Start
September 1, 2020
Primary Completion
February 15, 2021
Study Completion
February 15, 2021
Last Updated
February 17, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share