Clinical trial NCT04296201: 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
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Muscle Contracture
Lead sponsor: Lumenis Be Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-05
Enrollment: 15
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. Subject read, understood and signed the Consent Form
2. Healthy male or female aged 25-45 years,
3. Fitzpatrick skin type 1-6
4. Subject is capable of reading, understanding and following instructions of the procedure to be applied.
5. Subject is able and willing to comply with the treatment.
6. 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

1. 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.
2. Concurrent participation in any other study.

   Specific to the treatment and treatment area
3. Subject has a pacemaker or internal defibrillator, implanted neurostimulators or any other internal electric device or patient who had an implant in the past.
4. Subject has metal or other implants in the treatment area (Not including dental fillings, implants and crowns).
5. Subject has significant concurrent skin conditions affecting areas to be treated such as sores, bleeding, skin fragility, eczema or psoriasis.
6. 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
7. Subject has used oral isotretinoin (Accutane or Roaccutan®) within 6 months prior to study enrollment or plans use during the course of the study.
8. Subject has used topical retinoids in past 1 month

   Medical conditions/ use of medication
9. Subject has current or history of systemic cancer; premalignant skin lesion or skin concern treatment area.
10. Subject has severe concurrent conditions such as epilepsy, autoimmune, pulmonary or cardiac disorders.
11. Subject has poorly controlled endocrine disorders such as diabetes.
12. Subject has an impaired immune system due to immunosuppressive diseases such as HIV or AIDS, or use of immunosuppressive medications.
13. Subject has history of collagen disorders, keloid formation or abnormal wound healing.
14. Subject takes or has taken medications, herbal preparations, food supplements or vitamins that might cause fragile skin or impaired skin healing
15. Subject has used oral steroids in past 6 months
16. Subject has used topical steroids in past 3 months
17. Subject has history of bleeding coagulopathies or use of anticoagulants.
18. Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen containing agents) one week before and after each treatment session prior to treatment
19. Subject has mental disorders that in the opinion of the Investigator would be interfere with ability to comply with the study requirements.
20. Subject has any other medical condition that in the opinion of the Investigator warrants exclusion from this study

Primary outcomes:
measure: To evaluate the immediate effects and safety of DMATM novel muscle stimulation technology on the face, buttocks, and abdominal regions: GAI scale
timeFrame: 6 months
Secondary outcomes:
measure: To evaluate procedure-related skin safety, subject discomfort, and subject satisfaction: questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC
state: North Carolina
Study officials:
References: