AcneNCT06868615
AVAVA MIRIA General Use
A study testing AVAVA in people with Acne and Acne Scars - Mixed Atrophic and Hypertrophic, run by AVAVA, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne, Acne Scars - Mixed Atrophic and Hypertrophic, Scars
- What is being tested?
- AVAVA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2024to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects between 18 to 70 years of age.
- Dermatologic condition that can be addressed by the laser, including but not limited to:
- Wrinkles
- Scars
- Acne Scars
- Active Acne
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- Dyschromia
- Cutaneous Lesions such as Age or Sun Spots
- Melasma
- Laxity
- Willingness to have digital photographs taken of treatment area(s) and agreement with use of photographs for presentation, educational, or marketing purposes.
- Willingness to comply with the following during the study, including the follow-up period:
- maintain consistent skin care regimen on treated areas.
- cover treated areas or have very limited sun exposure and, if requested, use an approved sunscreen of SPF 50 or higher.
- refrain from using systemic corticosteroids, according to Investigator discretion.
- refrain from using topical corticosteroids, retinoids, or prescription skin-lightening medications on the treated areas, according to Investigator discretion.
- refrain from any other procedures in the treatment areas.
- Willingness and ability to comply with study instructions and return for required visits.
- Subject has read and signed a written informed consent form.
- Subject lives within 50 miles of study site.
- Willingness to shave hair in intended treatment area
Who cannot join
- 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
- Injection of dermal filler in the target areas within previous 1 month (e.g., collagen, hyaluronic acid filler)
- Cosmetic procedures in the target areas within prior 3 months (e.g., laser, microdermabrasion, skin peel)
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- Topical treatment applied to target areas within the previous 1 month or according to Investigator discretion.
- Active suntan and unable or unlikely to refrain from tanning within the follow-up period.
- Artificial tanning in the target areas within the previous 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period.
- Active localized or systemic infection, or an open wound in area being treated.
- Lesions in the treatment areas suspicious for malignancy (skin cancer, melanoma)
- History of abnormal wound healing or abnormal scarring (e.g., hypertrophic or keloid)
- History of connective tissue disease, such as lupus or scleroderma.
- Any use of medication that is known to increase sensitivity to light according to Investigator's discretion (e.g., topicals that produce sensitivity to light may be used in areas other than the target area).
- History of gold therapy.
- History of disease stimulated by heat, such as recurrent herpes simplex or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
- History of radiation to the treatment area or currently undergoing systemic chemotherapy for the treatment of cancer.
- For Female: Pregnancy or lactation, or intent to become pregnant within the study period.
- Significant uncontrolled concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
- History of immunosuppression/immune deficiency disorder or currently using immunosuppressive medications.
- Current enrollment in a clinical study of any other unapproved investigational drug or device
- Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
AVAVA, Inc.
Waltham, Massachusetts, 02451
Alexander Denis, 6176936669, adenis@avavaskin.com
About this study
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.
- Conditions
- Acne, Acne Scars - Mixed Atrophic and Hypertrophic, Scars, Wrinkle, Pigment; Lesion, Skin Texture Disorder
- Being tested
- AVAVA
- Medical subject headings
- Acne Vulgaris, Hypertrophy, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVAVADevice
1550nm Non-Ablative Fractional Laser
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subjects treated with the AVAVA Device Receives: Device: AVAVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediate Post-Treatment
Secondary outcomes (6)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: Immediate Post Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start11 Sep 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AVAVA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868615
- Sponsor's protocol ID
- AV-24-003
- Status last verified
- Sep 2026
- First submitted
- 6 Mar 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share individual data with other researchers at this time.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVAVA MIRIA General Use
- ClinicalTrials.gov ID
- NCT06868615
- Acronym / sponsor ID
- AV-24-003
- Conditions
- Acne, Acne Scars - Mixed Atrophic and Hypertrophic, Scars, Wrinkle, Pigment; Lesion, Skin Texture Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AVAVA, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: AVAVASubjects treated with the AVAVA Device |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male or female subjects between 18 to 70 years of age.
- Dermatologic condition that can be addressed by the laser, including but not limited to:
- Willingness to have digital photographs taken of treatment area(s) and agreement with use of photographs for presentation, educational, or marketing purposes.
- Willingness to comply with the following during the study, including the follow-up period:
- Willingness and ability to comply with study instructions and return for required visits.
Key exclusion criteria (22 listed)
- 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
- Injection of dermal filler in the target areas within previous 1 month (e.g., collagen, hyaluronic acid filler)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVAVA1550nm Non-Ablative Fractional Laser | Device | Intervention |
Primary outcome
Completion of Post-Treatment Subject Questionnaire
Time frame: Immediate Post-Treatment
Post-treatment questionnaire to evaluate the overall patient experience including descriptions of the treatment session and overall patient experience.
6 secondary outcomes
Blinded Assessment of Before and After Imaging by Trained Dermatologist
Time frame: Baseline, 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment
Completion of Follow-Up Subject Questionnaire
Time frame: 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment
Physician Rated Satisfaction
Time frame: Baseline, 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment
Subject Rated Satisfaction
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
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
Time frame: Immediate Post Treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. No plan to share individual data with other researchers at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVAVA in people with Acne and Acne Scars - Mixed Atrophic and Hypertrophic, run by AVAVA, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Denis (6176936669, studies@avavaskin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Post-Treatment Subject Questionnaire (time frame: Immediate Post-Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.