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This is a non-randomized, multi-center, open-label, prospective clinical study evaluating the clinical treatment with Candela Medical Technology.
Subjects may receive treatment with one applicator or combination of any of the devices and applicators and/or additional commercial devices, products, and procedures. Evaluations may include combination treatments, sequential treatments, split face treatments, exploration of treatment and system parameters, and evaluation of exploratory indications. Treatments may include evaluation of commercial Candela systems with modification in hardware or software and/or treatment outside of treatment guidelines and exploratory indications (off-label) for evaluation of clinical feedback, device components, and treatment outcomes.
Subjects may receive up to twelve (12) treatments. Treatments may occur with a minimum treatment interval of 2 weeks and maximum treatment interval of 12 weeks. The number and interval of treatments will depend upon the device(s), treatment area, and indication to be treated. Follow-up visits may be required per PI discretion. Follow-up visits may occur virtually or in person.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Treatment will be performed with commercial products manufactured by Candela and may also include non-Candela products. All devices will be used per the manufacturer's instructions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nordlys, Gentle, Picoway, Vbeam, Profound, Profound Matrix, eTwo, Exceed, CO2RE | Device | Subjects will receive up to twelve (12) treatments at minimum treatment interval of 2 weeks and maximum treatment interval of 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 last treatment, up 132 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 last treatment, up to 132 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konika P 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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| Marlborough |
| Massachusetts |
| 01752 |
| United States |
| Yokneam Candela Clinic | Yokneam Illit | 20692 | Israel |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D002921 | Cicatrix |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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