Status:
ACTIVE_NOT_RECRUITING
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
Lead Sponsor:
Candela Corporation
Conditions:
Skin Laxity
Wrinkle
Eligibility:
All Genders
18-75 years
Phase:
NA
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, ...
Eligibility Criteria
Inclusion
- Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick Skin Type I - VI.
- Willing to receive Profound Matrix treatments with any of the following applicators: Sublime, Sublative RF, and/or Matrix Pro applicator
- Able and willing to comply with the treatment/follow-up schedule and comply with all study (protocol) requirements.
- Willing to provide signed, informed consent to participate in the study
- 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
- Any of the following will exclude the subject from the study:
- Pregnant or planning to become pregnant, having given birth less than 3 months prior to enrollment into the study, and/or breast feeding
- Pacemaker or internal defibrillator or any active electrical implant anywhere in the body
- 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
- Skin cancer in the treatment area or history of melanoma
- History of current cancer and subject has undergone chemotherapy within the last 12 months
- Severe concurrent conditions, such as cardiac disorders
- Impaired immune system or use of immunosuppressive medications
- Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen
- Poorly controlled endocrine disorders such as poorly controlled diabetes
- Active skin condition in the treatment area such as skin infection, sores, psoriasis, eczema, rash, or open wounds
- History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very thin or fragile skin
- History of collagen vascular disease or vasculitic disorders
- Known allergy to medication to be used during treatments such as allergy to topical anesthetic (e.g. lidocaine)
- History of systemic corticosteroid therapy in past six months
- Tattoos or permanent makeup in the intended treatment area
- Excessively tanned skin
- Facelift in the last 12 months
- Aesthetics treatments/procedures (e.g. facial resurfacing and deep chemical peeling) within the last 4 months within the intended treatment area
- 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
- Permanent synthetic fillers (e.g. silicone) in the treatment area
- Absorbable facial threads within the last 1 year or non-absorbable facial threads within the intended treatment area
- 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
Key Trial Info
Start Date :
May 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 24 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06157567
Start Date
May 24 2022
End Date
May 24 2028
Last Update
August 22 2025
Active Locations (6)
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1
Center for Morden Aesthetic Medicine
Jacksonville, Florida, United States, 32207
2
Candela Institue for Excellence
Marlborough, Massachusetts, United States, 01752
3
Concierge Medical Arts
Fayetteville, North Carolina, United States, 28306
4
Gerrish MedEsthetics
Vienna, Virginia, United States, 22180