Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System

Launched by CANDELA CORPORATION · Dec 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a treatment called the Profound Matrix system, which aims to improve skin laxity, reduce wrinkles, and enhance overall skin condition. The trial is currently recruiting participants who are healthy adults aged 18 to 75 years old, regardless of gender, and who have specific skin types. Those interested in joining must be willing to receive treatments using certain applicators and agree to follow the study's guidelines, including providing consent and having their treated areas photographed for evaluation purposes.

Participants in this trial can expect to receive treatments that could help improve their skin while being closely monitored for any safety concerns. However, there are certain criteria that could exclude someone from participating, such as being pregnant, having specific medical devices like pacemakers, or having certain skin conditions. Overall, this study aims to gather important information about how well the Profound Matrix system works and if it is safe for a wide range of individuals. If you think you might be a good fit for this trial, it's a good idea to discuss it with your healthcare provider for more guidance.

Gender

ALL

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