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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
1550nm Non-Ablative Fractional Laser
AVAVA, Inc.
Waltham, Massachusetts, United States
RECRUITINGCompletion of Post-Treatment Subject Questionnaire
Post-treatment questionnaire to evaluate the overall patient experience including descriptions of the treatment session and overall patient experience.
Time frame: Immediate Post-Treatment
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.
Time frame: Baseline, 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment
Completion of Follow-Up Subject Questionnaire
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
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment
Physician Rated Global Clinical Aesthetic Improvement Scale Scoring
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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
Time frame: 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)
Time frame: Immediate Post Treatment