Skin LaxityNCT04296201
Evaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology
A study testing DMA treatment in people with Skin Laxity and Muscle Contracture, run by Lumenis Be Ltd. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity, Muscle Contracture
- What is being tested?
- DMA treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 15 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC
Charlotte, North Carolina, 28207
About this study
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.
Read the 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
- Conditions
- Skin Laxity, Muscle Contracture
- Being tested
- DMA treatment
- Medical subject headings
- Cutis Laxa, Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMA treatmentDevice
Each arm will receive the DMA treatment in a specific area on the body to observe immediate effect.
| Study group | Role | What they receive |
|---|---|---|
| Treatment in the face area | Experimental | 5 female subjects will receive treatment in the face area Receives: Device: DMA treatment |
| Treatment in the buttocks area | Experimental | 5 female subjects will receive treatment in the buttocks area Receives: Device: DMA treatment |
| Treatment in the abdominal region | Experimental | 5 male subjects will receive treatment in the abdominal region Receives: Device: DMA treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Sep 2020
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296201
- Sponsor's protocol ID
- LUM-ABU-DMA-20-01
- Status last verified
- Feb 2021
- First submitted
- 2 Mar 2020
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology
- ClinicalTrials.gov ID
- NCT04296201
- Acronym / sponsor ID
- LUM-ABU-DMA-20-01
- Conditions
- Skin Laxity, Muscle Contracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment in the face area | Experimental | Device: DMA treatment5 female subjects will receive treatment in the face area |
| Treatment in the buttocks area | Experimental | Device: DMA treatment5 female subjects will receive treatment in the buttocks area |
| Treatment in the abdominal region | Experimental | Device: DMA treatment5 male subjects will receive treatment in the abdominal region |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMA treatmentEach arm will receive the DMA treatment in a specific area on the body to observe immediate effect. | Device | Treatment in the abdominal region, Treatment in the buttocks area, Treatment in the face area |
Primary outcome
To evaluate the immediate effects and safety of DMATM novel muscle stimulation technology on the face, buttocks, and abdominal regions: GAI scale
Time frame: 6 months
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)
1 secondary outcome
To evaluate procedure-related skin safety, subject discomfort, and subject satisfaction: questionnaire
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DMA treatment in people with Skin Laxity and Muscle Contracture, run by Lumenis Be Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the immediate effects and safety of DMATM novel muscle stimulation technology on the face, buttocks, and abdominal regions: GAI scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.