Status:
COMPLETED
Functional Usability and Feasibility Testing of the Profound Matrix™ System
Lead Sponsor:
Candela Corporation
Conditions:
Wrinkle
Acne Scars - Mixed Atrophic and Hypertrophic
Eligibility:
All Genders
18-75 years
Phase:
NA
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 an...
Eligibility Criteria
Inclusion
- Healthy Male or Female
- Age 18 to 75
- 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
- Presence of at least mild wrinkles or mild acne scars or uneven skin texture, as assessed by the Investigator
- Willingness to provide signed, informed consent to participate in the study
- Willingness to allow photography of treated areas, and to release their use for scientific/educational and/or promotional purposes
Exclusion
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, 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
- Current skin cancers 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 due to immunosuppressive diseases such as AIDS and HIV, 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 diabetes
- Active skin condition in the treatment area such as sores, psoriasis, eczema, or rash, open wounds, and severe active inflammatory acne.
- History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very dry and fragile skin
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitis disorders
- Known allergy to lidocaine, tetracaine, Xylocaine, epinephrine or ProNox (nitrous oxide (laughing gas))
- Patients on systemic corticosteroid therapy in past six months
- Is taking medication(s) for which sunlight is a contraindication
- Tattoos or permanent makeup in the intended treatment area
- Excessively tanned skin
- 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.
- Subject has hair and is unwilling to have hair removed from the treatment area
- Subjects has undergone facelift in the last 12 months
- 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
- Subject has undergone Botox in the treatment area within the last 3 months
- Subject has non-permanent filler in the last 3 months within the intended to treat area
- Subject has permanent filler (e.g. silicone) within the intended to treat area
- Subject has absorbable facial threads within the last 2 years within the intended to treat area
- 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
Key Trial Info
Start Date :
October 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2023
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT06192550
Start Date
October 28 2020
End Date
December 29 2023
Last Update
February 13 2025
Active Locations (5)
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1
Candela Institue for Excellence
Marlborough, Massachusetts, United States, 01752
2
NY Derm
New York, New York, United States, 10028
3
OptiSkin
New York, New York, United States, 10128
4
Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, United States, 28207