Clinical trial NCT06192550: Functional Usability and Feasibility Testing of the Profound Matrix™ System
Official title: Functional Usability and Feasibility Testing of the Profound Matrix™ System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Acne Scars - Mixed Atrophic and Hypertrophic
Lead sponsor: Candela Corporation
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a non-randomized, multi-center, open-label clinical trial evaluating the efficacy and clinical feasibility of the Profound Matrix device for electrocoagulation and for treatment of wrinkles and acne scars. Subjects will receive up to three (3) treatments with the Matrix Pro applicator or up to five (5) treatments with the Sublime and/or Sublative Radiofrequency (RF) applicators.


Eligibility criteria: Inclusion Criteria:

1. Healthy Male or Female
2. Age 18 to 75
3. Subjects seeking treatment for facial, abdominal, or back wrinkles reduction, skin texture improvement and/or acne scars appearance improvement and willing to undergo RF treatments for improvement
4. Presence of at least mild wrinkles or mild acne scars or uneven skin texture, as assessed by the Investigator
5. Willingness to provide signed, informed consent to participate in the study
6. Willingness to allow photography of treated areas, and to release their use for scientific/educational and/or promotional purposes

Exclusion Criteria:

1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, 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 these implants can be removed or covered with rolled gauze during treatment
4. Current skin cancers in the treatment area or history of melanoma
5. History of current cancer and subject has undergone chemotherapy within the last 12 months
6. Severe concurrent conditions, such as cardiac disorders
7. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
8. Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen
9. Poorly controlled endocrine disorders such as diabetes
10. Active skin condition in the treatment area such as sores, psoriasis, eczema, or rash, open wounds, and severe active inflammatory acne.
11. History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very dry and fragile skin
12. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitis disorders
13. Known allergy to lidocaine, tetracaine, Xylocaine, epinephrine or ProNox (nitrous oxide (laughing gas))
14. Patients on systemic corticosteroid therapy in past six months
15. Is taking medication(s) for which sunlight is a contraindication
16. Tattoos or permanent makeup in the intended treatment area
17. Excessively tanned skin
18. Subjects with pigmented lesions that are considered not acceptable by the study investigator or any condition that, in the investigator's opinion, would make it unsafe to treat.
19. Subject has hair and is unwilling to have hair removed from the treatment area
20. Subjects has undergone facelift in the last 12 months
21. Subject has undergone aesthetics treatments/procedures (e.g. facial resurfacing and deep chemical peeling) within the last 4 months) within the intended to treat area
22. Subject has undergone Botox in the treatment area within the last 3 months
23. Subject has non-permanent filler in the last 3 months within the intended to treat area
24. Subject has permanent filler (e.g. silicone) within the intended to treat area
25. Subject has absorbable facial threads within the last 2 years within the intended to treat area
26. Subject has non-absorbable facial threads within the intended to treat area aa. Subject is using a topical in the treatment area that the Investigator's deems the subject unsuitable for the study.

bb. In the opinion of the Investigator, the subject is unwilling or unable to adhere to the study requirements

Primary outcomes:
measure: Investigator Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance
timeFrame: 3 months post final treatment
Secondary outcomes:
measure: Subject Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance
timeFrame: 3 months post final treatment
Other outcomes:
Locations:
city: Marlborough
country: United States
facility: Candela Institue for Excellence
state: Massachusetts
city: New York City
country: United States
facility: OptiSkin
state: New York
city: New York
country: United States
facility: NY Derm
state: New York
city: Charlotte
country: United States
facility: Laser & Vein Specialists of the Carolinas
state: North Carolina
city: Yoqne'am 'Illit
country: Israel
facility: Syneron Medical
Study officials:
affiliation: Candela Medical
name: Konika Schallen, MD
role: PRINCIPAL_INVESTIGATOR
References: