Evaluate the efficacy and safety of the Matrix Pro Applicator on Profound Matrix system in the treatment of facial, submental and neck laxity.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluation of facial, submentum, and neck laxity reduction based on correct
identification of subject*s post-treatment photograph (study endpoint: 3 months
post last-treatment) and at least a 1-point decrease on the Facial Laxity
Rating Scale (FLRS) at study endpoint relative to baseline as rated by the 3
independent blinded raters. Success criteria is defined as a responder rate of
at least 70% of study subjects meeting the co-primary endpoints by at least 2
of the 3 independent blinded raters.
Adverse events will be tabulated by type, severity, relation to treatment,
action taken and outcome.
Secondary outcome
Investigator FLRS at 1- and 3-month follow up
IGAIS at 1- and 3-month follow up
Subject GAIS at 1- and 3-month follow up
Subject satisfaction questionnaire at 1- and 3-month follow up
Subject ratings of treatment discomfort/pain immediately post-treatment via
Numerical Rating Scale (NRS)
Local skin response to treatment will be assessed immediately after treatment
by type and severity according to the Post-Treatment Severity Scale
Background summary
In recent years, there has been a growing demand for non-surgical procedures to
improve skin imperfections. As demand from patients and healthcare providers
has grown, new treatments and technologies have also been introduced. This
technique creates a small damage in the skin using needles in combination with
radio waves, allowing a natural healing response of the skin. This technique is
already widely used in practice. Experience and research show that this
technique using radio waves is safe, even for people with skin that is
difficult to treat, such as dark skin. Handpieces are used that are connected
to a central system ('console'). The Profound Matrix system has three
handpieces: Matrix Pro, Sublative RF and Sublime applicators. The Matrix Pro
handpiece uses a combination of radio waves and microneedles and is the
handpiece that will be used in this study.
The Matrix Pro applicator uses new and advanced technology to provide users
with a customizable treatment approach based on patient needs. The Matrix Pro
applicator features an array of the thinnest microneedles on the market that
fractionally deliver short-pulse RF energy to the skin. The device design
ensures improved patient comfort, reduced risk of side effects and reduced
downtime for patients, while delivering clinical results via RF microneedle
technology. Additionally, the Matrix platform is the first of its kind and
uniquely equipped with impedance monitoring and depth intelligence technology
and software to ensure accurate energy delivery, provide real-time user
feedback and enable consistent patient outcomes.
The combination of fractional RF microneedle technology coupled with the unique
impedance feedback and depth intelligence technology highlights the advantages
of the Matrix Pro applicator over competing devices and comparable energy-based
aesthetic technology. There is an unmet patient need for nonsurgical options
for the treatment of laxity. Although surgical methods and aggressive laser
treatments (such as CO2 lasers and ablative lasers) are considered the gold
standard for skin laxity complaints, they face a high rate of complications and
serious risks for patients, as well as pain and discomfort and prolonged
periods of downtime. . The new Matrix technology offers this effective
non-surgical alternative without the potential risks of current treatment
modalities.
Study objective
Evaluate the efficacy and safety of the Matrix Pro Applicator on Profound
Matrix system in the treatment of facial, submental and neck laxity.
Study design
This is a non-randomized, multi-center, open-label prospective clinical trial
evaluating clinical treatments with the Matrix Pro Applicator on the Profound
Matrix delivery system for the improvement of facial and/or submental and neck
laxity.
There will be up to three (3) study treatments, each 6 weeks ± 2 weeks apart.
Follow-up visits will occur at the following timepoints:
1-month (4 weeks ± 2 week) follow up (after last treatment)
3-month (13 weeks ± 2 weeks) follow up (after last treatment)
Additional follow-up visits may be required per Sponsor and PI discretion
Study burden and risks
The treatments involve risks of skin reactions that also occur with other
aesthetic treatments. The skin reactions are usually at the treatment site and
often no more than mild to moderate. They often disappear a few days after
treatment.
In addition, the subjects will only be asked to give their satisfaction and
pain scores and the burden will consist of no more than the time the subject
invests in participation. This extra time commitment is limited compared to
comparable treatments.
Locke Drive 251
Marlborough 01752
US
Locke Drive 251
Marlborough 01752
US
Listed location countries
Age
Inclusion criteria
1. Healthy female and male subjects between 18 to 84 years of age with
Fitzpatrick Skin Type I - VI.
2. Willing to receive Profound Matrix treatments with Matrix Pro applicator
3. Able and willing to comply with the treatment/follow-up schedule and comply
with all study (protocol) requirements.
4. Willing to provide signed, informed consent to participate in the study
5.Willing to have photographs and images taken of the treated areas to be used
in evaluations, publications, presentations, and marketing materials (Subject
identity will be masked).
Exclusion criteria
1. Pregnant or planning to become pregnant, having given birth less than 3
months prior to enrollment into the study, and/or breast feeding
2. Pacemaker or internal defibrillator or any active electrical implant
anywhere in the body
3. Superficial metal or other implants in the treatment area, except
superficial dental implants, unless the implants can be removed or covered with
rolled gauze during treatment
4. Skin cancer in the treatment area or history of melanoma
5. History of current cancer and/or subject has undergone chemotherapy within
the last 12 months
6. Severe concurrent conditions, such as cardiac disorders
7. Impaired immune system or use of immunosuppressive medications, except for
topical products and inhaler medications per investigator discretion
8. Herpes Simplex Virus (HSV) in the intended treatment area unless treated
following a prophylactic regimen
9. Poorly controlled endocrine disorders such as poorly controlled diabetes
10. Active skin condition in the treatment area such as skin infection, sores,
psoriasis, eczema, rash, or open wounds
11. History of abnormal wound healing, keloid, or hypertrophic scar formation,
as well as very thin or fragile skin
12. History of collagen vascular disease or vasculitic disorders
13. Known allergy to medication to be used during treatments such as allergy to
topical anesthetic (e.g., lidocaine)
14. History of systemic corticosteroid therapy in past six months
15. Tattoos or permanent makeup in the intended treatment area
16. Excessively tanned skin
17. Facelift in the last 12 months
18. Aesthetics treatments/procedures (e.g., facial resurfacing and deep
chemical peeling) within the last 4 months within the intended treatment area
19. Neuromodulator injections (e.g., Botox®), collagen, non-permanent dermal
filler, fat injections or other methods of augmentation with injected
biomaterial in the intended treatment area within the last 3 months
20. Permanent synthetic fillers (e.g., silicone) in the intended treatment area
21. Absorbable facial threads within the last 12 months or non-absorbable
facial threads within the intended treatment area
22. In the opinion of the Investigator, the subject is unwilling or unable to
adhere to the study requirements or is otherwise unsuitable for study
participation.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84830.000.24 |