AVAVA for Acne
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Overseen ByAlexander Denis
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: AVAVA, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of 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 is for individuals with various skin conditions such as acne, scarring, wrinkles, pigmented lesions, and skin texture disorders. It's also open to those with pulmonary artery hypertrophy. Specific eligibility criteria are not provided.Inclusion Criteria
Willingness to have digital photographs taken of treatment area(s) and agreement with use of photographs for presentation, educational, or marketing purposes
I am willing to shave my hair in the area to be treated.
I am willing to follow a skin care plan, limit sun exposure, and avoid certain medications and procedures on treated areas.
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Exclusion Criteria
I have an infection or an open wound in the area that needs treatment.
I have a connective tissue disease like lupus or scleroderma.
I haven't had surgery in the target area in the last 6 months.
See 19 more
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Subjects treated with the AVAVA Device for dermatologic conditions
Immediate Post-Treatment
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
3 visits (in-person) at 3, 6, and 12 months post-treatment
Treatment Details
Interventions
- AVAVA
Trial Overview The AVAVA device is being tested on patients with different dermatologic issues. The main goal is to gather patient feedback through questionnaires about their experience using the device.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Subjects treated with the AVAVA Device
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Who Is Running the Clinical Trial?
AVAVA, Inc.
Lead Sponsor
Trials
4
Recruited
500+
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