An interventional study of AVAVA in Acne, Acne Scars - Mixed Atrophic and Hypertrophic and Scars, sponsored by AVAVA, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by AVAVA, Inc. · Not applicable, Interventional, and Treatment
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.
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's planned enrollment of 200 is above the median of 70 across 672 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →AVAVA, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Dermatologic condition that can be addressed by the laser, including but not limited to:
Willingness to comply with the following during the study, including the follow-up period:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects treated with the AVAVA Device
Device: AVAVA
1550nm Non-Ablative Fractional Laser
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
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
PGAIS - Physician Rated Global Clinical Aesthetic Improvement Scale Scoring
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
Plan to share: No — No plan to share individual data with other researchers at this time.
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Dec 2027, 39 months after the start.
Of 62 industry-sponsored interventional studies with no phase under Acne Vulgaris, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 19. This study's planned 39 months is above that.
Counting every sponsor, half of 120 studies reached it within 9 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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