Acne Scars - Mixed Atrophic and Hypertrophic, Wrinkle
Conditions
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 and acne scars. Subjects will receive up to three (3) treatments with the Matrix Pro applicator or up to five (5) treatments with the Sublime and/or Sublative Radiofrequency (RF) applicators.
Interventions
DEVICEProfound Matrix™ System
Study subjects will be treated with the Profound Matrix System
Sponsors
Candela Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Male or Female 2. Age 18 to 75 3. 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 4. Presence of at least mild wrinkles or mild acne scars or uneven skin texture, as assessed by the Investigator 5. Willingness to provide signed, informed consent to participate in the study 6. Willingness to allow photography of treated areas, and to release their use for scientific/educational and/or promotional purposes
Exclusion criteria
1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, 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. Current skin cancers 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 due to immunosuppressive diseases such as AIDS and HIV, 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 diabetes 10. Active skin condition in the treatment area such as sores, psoriasis, eczema, or rash, open wounds, and severe active inflammatory acne. 11. History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very dry and fragile skin 12. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitis disorders 13. Known allergy to lidocaine, tetracaine, Xylocaine, epinephrine or ProNox (nitrous oxide (laughing gas)) 14. Patients on systemic corticosteroid therapy in past six months 15. Is taking medication(s) for which sunlight is a contraindication 16. Tattoos or permanent makeup in the intended treatment area 17. Excessively tanned skin 18. 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. 19. Subject has hair and is unwilling to have hair removed from the treatment area 20. Subjects has undergone facelift in the last 12 months 21. 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 22. Subject has undergone Botox in the treatment area within the last 3 months 23. Subject has non-permanent filler in the last 3 months within the intended to treat area 24. Subject has permanent filler (e.g. silicone) within the intended to treat area 25. Subject has absorbable facial threads within the last 2 years within the intended to treat area 26. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance | 3 months post final treatment | Perceived improvement in overall appearance according to the 5-point Global Aesthetic Improvement Scale from -1= Worse to 3= Very Much Improved as assessed by investigator at study endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance | 3 months post final treatment | Perceived improvement in overall appearance according to the 5-point Global Aesthetic Improvement Scale from -1= Worse to 3= Very Much Improved as assessed by subject at study endpoint |
Countries
Israel, United States
Outcome results
None listed