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A general protocol to treat a variety of dermatologic conditions and collect patient feedback.
Primary outcome is the collection and analysis of patient questionnaires related to the overall experience of the device treatment. Secondary outcome measures include physician and subject evaluations in regards to improvement seen in the device as well as assessment of side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Subjects treated with the AVAVA Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVAVA | Device | 1550nm Non-Ablative Fractional Laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completion of Post-Treatment Subject Questionnaire | Post-treatment questionnaire to evaluate the overall patient experience including descriptions of the treatment session and overall patient experience. | Immediate Post-Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Blinded Assessment of Before and After Imaging by Trained Dermatologist | Subject images will be placed in a randomized order and blinded graders will be asked to identify the post-treatment image. | Baseline, 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment |
| Completion of Follow-Up Subject Questionnaire |
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Inclusion Criteria:
Male or female subjects between 18 to 70 years of age.
Dermatologic condition that can be addressed by the laser, including but not limited to:
Willingness to have digital photographs taken of treatment area(s) and agreement with use of photographs for presentation, educational, or marketing purposes.
Willingness to comply with the following during the study, including the follow-up period:
Willingness and ability to comply with study instructions and return for required visits.
Subject has read and signed a written informed consent form.
Subject lives within 50 miles of study site.
Willingness to shave hair in intended treatment area
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Denis | Contact | 6176936669 | studies@avavaskin.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AVAVA, Inc. | Recruiting | Waltham | Massachusetts | 02451 | United States |
No plan to share individual data with other researchers at this time.
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D006984 | Hypertrophy |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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Questionnaire evaluates the subject evaluated results of the study including questions related to the device such as whether or not they would participate in additional treatments or recommend the procedure to friends/family |
| 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment |
| Physician Rated Satisfaction | Percentage of subject results that treating physician was satisfied with at end of study. Physician Rated satisfaction with included options of Very Satisfied, Satisfied, Slightly Satisfied, Neutral, Dissatisfied. | Baseline, 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment |
| Subject Rated Satisfaction | Percentage of subjects satisfied with their results at end of study. Subject Rated satisfaction with included options of Very Satisfied, Satisfied, Slightly Satisfied, Neutral, Dissatisfied. | Baseline, 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment |
| Physician Rated Global Clinical Aesthetic Improvement Scale Scoring | Physician will be asked to rate subject improvement on a 5 point scale. 0 - Worsened, 1-No Change, 2-Minor Improvement, 3-Moderate Improvement, 4-Significant Improvement | Baseline, 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment |
| Subject tolerance of procedure based on pain score during treatment per Visual Analogue Scale | Subjects are asked to rate their pain scores from 0 (No pain) to 10 (worst imaginable pain) | Immediate Post Treatment |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |