AVAVA, Inc.
Waltham, Massachusetts, 02451, United States
Location status: Recruiting
NCT Number: NCT06868615
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Waltham, Massachusetts, 02451, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1550nm Non-Ablative Fractional Laser
Time frame: Immediate Post-Treatment
Post-treatment questionnaire to evaluate the overall patient experience including descriptions of the treatment session and overall patient experience.
Time frame: Baseline, 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment
Subject images will be placed in a randomized order and blinded graders will be asked to identify the post-treatment image.
Time frame: 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment
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: Baseline, 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment
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
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 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: Immediate Post Treatment
Subjects are asked to rate their pain scores from 0 (No pain) to 10 (worst imaginable pain)
Contact information is provided by the study sponsor or research team.
AVAVA, Inc.
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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