Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment

Launched by CANDELA CORPORATION · Dec 5, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called Matrix Pro, which is designed to improve skin laxity (looseness) and reduce wrinkles on the face, neck, and under the chin. The study will involve healthy men and women aged 18 to 84 who are willing to undergo the treatment. The goal is to see how well this treatment works and if it is safe for patients.

To participate, you need to be in good health and have certain skin types. However, if you are pregnant, breastfeeding, or have specific medical conditions (like certain cancers or skin infections), you won’t be eligible. Participants will receive the treatment and may have photos taken of the treated areas to help assess the results. This trial is not yet recruiting participants, but it aims to provide valuable information about Matrix Pro’s effectiveness and safety for improving skin appearance.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy female and male subjects between 18 to 84 years of age with Fitzpatrick Skin Type I - VI.
• • 2. Willing to receive Profound Matrix treatments with 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 the 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/or 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, except for topical products and inhaler medications per investigator discretion
• • 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, fat injections or other methods of augmentation with injected biomaterial in the intended treatment area within the last 3 months
• • 20. Permanent synthetic fillers (e.g., silicone) in the intended treatment area
• • 21. Absorbable facial threads within the last 12 months 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 study participation