Evaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology

Skin Laxity Clinical Trial

Official title:

Evaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04296201
• Other study ID #: LUM-ABU-DMA-20-01
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: February 2021
• Source: Lumenis Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contracture
• Muscle Contracture
• Skin Laxity

Intervention

Device:
• DMA treatment
Each arm will receive the DMA treatment in a specific area on the body to observe immediate effect.

Locations

Country	Name	City	State
United States	Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Lumenis Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 months