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This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive facial remodeling.
The study is a multicenter single-arm, open-label, interventional study. The subjects will be enrolled and assigned into a single experimental study arm. The subjects will be required to complete four (4) treatment visits and two follow-up visits.
At the baseline visit health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed.
The treatment administration phase consists of four (4) treatment visits, delivered 5-10 days apart.
Safety measures will include documentation of adverse events (AE) including the subject's experience of pain or discomfort after the procedure. Occurrence of AE's will be checked immediately after the first treatment visit, prior/post to every other procedure and at the follow-ups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-invasive facial remodeling | Experimental | Treatment with the BTL-785-7 applicator to the BTL-785F system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL-785-7 | Device | Treatment with the BTL-785-7 applicator to the BTL-785F system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-invasive facial remodeling | Evaluation of facial skin appearance based on photographs before and after the study procedure according to the Global Aesthetic Improvement Scale.The GAIS is a clinically validated assessment tool used to assess overall aesthetic improvement such as facelift on a scale from -1 through 3, where the higher score is considered better. | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of skin quality and aesthetic change of the treated areas after the therapies | Evaluation of skin quality and aesthetic change of the treated areas after the therapies based on photographs before and after the study procedure according to the Global Aesthetic Improvement Scale. The GAIS is a clinically validated assessment tool used to assess overall aesthetic improvement such as facelift on a scale from -1 through 3, where the higher score is considered better. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Bryan Kinney | Beverly Hills | California | 90212 | United States | ||
| BOYD Beauty |
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| 5 months |
| Subject Satisfaction | The Subject Satisfaction questionnaire will be used for evaluating the satisfaction. The Subject Satisfaction Questionnaire will be given to subjects after the last treatment, at 1-month and 3-month follow-up. The answers to the questions related to the subjects' overall skin and face appearance will vary from "strongly agree" to "strongly disagree". | 5 months |
| Therapy Comfort | The 5-point Likert scale Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. Pain sensation will be rated by the subjects from 0 (no pain) to 10 (worst possible pain). | 5 months |
| Birmingham |
| Michigan |
| 48009 |
| United States |