Functional Usability and Feasibility Testing of the Profound Matrix™ System

Wrinkle Clinical Trial

Official title:

Functional Usability and Feasibility Testing of the Profound Matrix™ System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06192550
• Other study ID #: FUFT2002
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 28, 2020
• Est. completion date: July 2024

Study information

• Verified date: December 2023
• Source: Candela Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 193
• Est. completion date: July 2024
• Est. primary completion date: September 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Scars - Mixed Atrophic and Hypertrophic
• Hypertrophy
• Wrinkle

Intervention

Device:
• Profound Matrix™ System
Study subjects will be treated with the Profound Matrix System

Locations

Country	Name	City	State
Israel	Syneron Medical	Yoqne'am 'Illit
United States	Laser & Vein Specialists of the Carolinas	Charlotte	North Carolina
United States	Candela Institue for Excellence	Marlborough	Massachusetts
United States	NY Derm	New York	New York
United States	OptiSkin	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Candela Corporation

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wrinkle reduction (Group 1 and Group 3 only)	Improvement in the appearance of wrinkles based on the Investigator or staff assessment.	Assessed at Baseline and at 3 Month Follow Up
Primary	Acne scar appearance improvement (Group 1 and Group 3 only)	Improvement in the appearance of acne scars based on the Investigator or staff assessment.	Assessed at Baseline and at 3 Month Follow Up
Secondary	Group 2 wrinkle reduction	Improvement in the appearance of wrinkles based on the Investigator or staff assessment.	Assessed at Baseline and at 3 Month Follow Up
Secondary	Group 2 wrinkle acne scar appearance improvement	Improvement in the appearance of acne scars based on the Investigator or staff assessment.	Assessed at Baseline and at 3 Month Follow Up