sagging of skin skin conditions
Conditions
Interventions
None listed
Sponsors
Candela Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed