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

Completed · Not applicable

Conditions studied: Skin Laxity, Muscle Contracture

In brief

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.

Key facts

Study ID: NCT04296201
Run by: Lumenis Be Ltd.
People needed: 15
Starts: 2020-09-01
Expected to finish: 2021-02-15
Last updated by the study team: 2021-02-17

Who can join

Age: 25 and older, up to 45. Sex: any. Healthy volunteers: accepted.

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.
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

Where it is running

Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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