Skin Condition, Skin Laxity, Wrinkle
Conditions
Brief summary
This is a non-randomized, multi-center, open-label, prospective clinical trial evaluating clinical treatments with the Matrix Pro Applicator for the improvement of facial and/or submental and neck laxity.
Detailed description
Eligible participants will receive up to three treatments with the Matrix Pro Applicator of the Profound Matrix System to address facial and neck laxity. Treatments will be approximately 6 weeks apart (± 2 weeks). All participants will undergo follow-up evaluations at 1 month (4 weeks ± 2 weeks) and 3 months (13 weeks ± 2 weeks) after the final treatment. Additional follow-up visits may be required per Sponsor and PI discretion
Interventions
DEVICEProfound Matrix
Treatment visits are limited to up to three (3) study treatments (with treatment intervals 6 weeks ± 2 weeks).
Sponsors
Candela Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
Yes
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
Any of the following will exclude the subject from the study: 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 outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of change in facial, submentum, and neck laxity | From subject enrollment to completion of 3-month follow-up visit, up to 32 weeks. | Evaluation of change in facial, submentum, and neck laxity based on correct identification of subject's post-treatment photograph by at least 2 of the 3 independent blinded reviewers. |
Countries
Netherlands, United Kingdom
Outcome results
None listed