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This is a non-randomized, multi-center, open-label clinical trial evaluating clinical feasibility treatments with the Profound Matrix system.
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, RF applicator and Matrix Pro applicator for aesthetic treatments including its cleared indications of wrinkles, acne scars, striae, and electrocoagulation and hemostasis. The Sublime and Sublative RF applicators are equivalent to those on the European conformity (CE) marked eLos, eTwo, eMatrix device family. The Matrix Pro applicator utilizes micro-needling technology and is new feature of the Profound Matrix system. The Profound Matrix system, including the Matrix Pro applicator are currently cleared for use in the US under FDA 510k K211217. This study aims to evaluate additional indications for treatment through the electrocoagulation and hemostasis mechanism of action for dermal remodeling and improvement in skin conditions to provide study subjects with a safe and effective alternative treatment that can be performed with minimal risks and decreased downtime. Eligible subjects would be healthy adult volunteers between 18 to 75 years of age seeking clinical treatment for indications as listed above. The research is sponsored by Candela Corporation and planned to be conducted at up to 20 sites globally. From the first subject enrollment to the last subject follow-up, the expected total duration is up to 5 years across all sites. The participants will undergo informed consent, screening and enrollment, treatments for the indication to be treated, and follow-up visits at no cost. The data from this research will assist Candela in optimizing treatment parameters, treatment guidelines, providing input to clinical education and marketing material, and support the research and development of micro-needling technology alongside energy-based devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Study subjects may be treated with any of the Profound Matrix applicators: Sublime, Sublative RF and/or Matrix Pro. Treatments may include combination of applicators or additional commercial devices per PI discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Profound Matrix | Device | Treatment visits are limited to up to three (3) study treatments (with treatment intervals 6 weeks ± 2 weeks). |
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| Measure | Description | Time Frame |
|---|---|---|
| Standardized Clinical Photography | Clinical photography will be taken of treated areas at baseline prior to treatment and all treatment and follow-up visits. | From subject enrollment to completion of 3-month follow-up visit, up to 32 weeks. |
| Numerical Rating Scale (NRS) | Subject assessment of treatment discomfort/pain immediately post-treatment via Numerical Rating Scale (NRS). Subjects will be presented a horizontal line scale and asked to make a mark along the scale. Subjects will be asked to rate pain from 0 to 10, with 0 equaling no pain and 10 equaling the worst possible pain. A number is obtained by measuring up to the point the participant has indicated. | From the first treatment to the third treatment, up to 16 weeks. |
| Post-treatment Assessment Severity Scale | Skin responses including edema, erythema, pinpoint bleeding, purpura/ecchymosis, petechiae, and microscopic epithelial necrotic debris (MENDs) will be assessed immediately after treatment with a post-treatment assessment severity scale: grade 1 means absent, grade 2 means mild, grade 3 means moderate, and grade 3 means severe. | From the first treatment to the third treatment, up to 16 weeks. |
| Investigator Global Aesthetic Improvement Scale (IGAIS) | Investigator Global Aesthetic Improvement Scale (IGAIS) will be assessed at each follow-up visit with score -1 to 3 and corresponding ratings: -1 means worse, 0 means no change, 1 means improved, 2 means much improved, 3 means very much improved. | At 1-month follow-up and 3-month follow-up, up to 14 weeks. |
| Subject Satisfaction Scale | Subject satisfaction rating of improvement in indication will be obtained at each follow-up visit. The subject satisfaction scale scores from -2 to 2 with corresponding improvement rate: -2 means very dissatisfied, -1 means somewhat satisfied, 0 means neutral, 1 means somewhat satisfied, 2 means very satisfied. |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following will exclude the subject from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Konika Schallen, MD | Candela Institue for Exellence | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Morden Aesthetic Medicine | Jacksonville | Florida | 32207 | United States | ||
| Candela Institue for Excellence |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| At 1-month follow-up and 3-month follow-up, up to 14 weeks. |
| Marlborough |
| Massachusetts |
| 01752 |
| United States |
| Concierge Medical Arts | Fayetteville | North Carolina | 28306 | United States |
| Gerrish MedEsthetics | Vienna | Virginia | 22180 | United States |
| Waterfront Skin and Laser | Vancouver | Canada |
| Candela European Institue of Excellence | Madrid | 28830 | Spain |
| D017437 | Skin and Connective Tissue Diseases |