AVAVA MIRIA General Use

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAVAVA, Inc.

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • AVAVA

    Device

    1550nm Non-Ablative Fractional Laser

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Immediate Post-Treatment

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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