About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female subjects between 18 to 70 years of age.
Wrinkles
Scars
Acne Scars
Disqualifiers
Skin pathology or condition that could interfere with evaluation of the study procedure, e.g.,
Systemic treatment prescribed within previous 6 months (e.g., oral medication such as isotretinoin)
Surgical treatment in the target areas within previous 6 months (e.g., laser surgery)
Active vitiligo, psoriasis, or eczema in the treatment area
Trial design
Single group
Treatments tested in this trial
AVAVA
Device1550nm Non-Ablative Fractional Laser
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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
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.
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.
Sponsors and contacts
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