Clinical trial NCT06157567: Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
Official title: Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Laxity
Wrinkle
Skin Condition
Lead sponsor: Candela Corporation
Sponsor class: INDUSTRY
First posted: 2023-12-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a non-randomized, multi-center, open-label clinical trial evaluating clinical feasibility treatments with the Profound Matrix system.

Detailed description: The Profound Matrix system is a multipurpose (3-in-1) radiofrequency (RF) platform. The clinical study is to evaluate the safety and performance of the Profound Matrix system with Sublime applicator, RF applicator and Matrix Pro applicator for aesthetic treatments including its cleared indications of wrinkles, acne scars, striae, and electrocoagulation and hemostasis. The Sublime and Sublative RF applicators are equivalent to those on the European conformity (CE) marked eLos, eTwo, eMatrix device family. The Matrix Pro applicator utilizes micro-needling technology and is new feature of the Profound Matrix system. The Profound Matrix system, including the Matrix Pro applicator are currently cleared for use in the US under FDA 510k K211217. This study aims to evaluate additional indications for treatment through the electrocoagulation and hemostasis mechanism of action for dermal remodeling and improvement in skin conditions to provide study subjects with a safe and effective alternative treatment that can be performed with minimal risks and decreased downtime. Eligible subjects would be healthy adult volunteers between 18 to 75 years of age seeking clinical treatment for indications as listed above. The research is sponsored by Candela Corporation and planned to be conducted at up to 20 sites globally. From the first subject enrollment to the last subject follow-up, the expected total duration is up to 5 years across all sites. The participants will undergo informed consent, screening and enrollment, treatments for the indication to be treated, and follow-up visits at no cost. The data from this research will assist Candela in optimizing treatment parameters, treatment guidelines, providing input to clinical education and marketing material, and support the research and development of micro-needling technology alongside energy-based devices.

Eligibility criteria: Inclusion Criteria:

1. Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick Skin Type I - VI.
2. Willing to receive Profound Matrix treatments with any of the following applicators: Sublime, Sublative RF, and/or 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 these 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 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
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, or fat injections or other methods of augmentation with injected bio-material in the treated area within the last 3 months
20. Permanent synthetic fillers (e.g. silicone) in the treatment area
21. Absorbable facial threads within the last 1 year 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 the study

Primary outcomes:
measure: Standardized Clinical Photography
timeFrame: From subject enrollment to completion of 3-month follow-up visit, up to 32 weeks.
measure: Numerical Rating Scale (NRS)
timeFrame: From the first treatment to the third treatment, up to 16 weeks.
measure: Post-treatment Assessment Severity Scale
timeFrame: From the first treatment to the third treatment, up to 16 weeks.
measure: Investigator Global Aesthetic Improvement Scale (IGAIS)
timeFrame: At 1-month follow-up and 3-month follow-up, up to 14 weeks.
measure: Subject Satisfaction Scale
timeFrame: At 1-month follow-up and 3-month follow-up, up to 14 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Center for Morden Aesthetic Medicine
state: Florida
city: Marlborough
country: United States
facility: Candela Institue for Excellence
state: Massachusetts
city: Fayetteville
country: United States
facility: Concierge Medical Arts
state: North Carolina
city: Vienna
country: United States
facility: Gerrish MedEsthetics
state: Virginia
city: Vancouver
country: Canada
facility: Waterfront Skin and Laser
city: Madrid
country: Spain
facility: Candela European Institue of Excellence
Study officials:
affiliation: Candela Institue for Exellence
name: Konika Schallen, MD
role: PRINCIPAL_INVESTIGATOR
References: