ClinicalTrials.gg
RecruitingNCT06868615Updated Sep 15, 2026

AVAVA MIRIA General Use

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

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Sep 2024, registered Mar 2025).
  • Started Sep 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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. Secondary outcome measures include physician and subject evaluations in regards to improvement seen in the device as well as assessment of side effects.

02

Conditions studied

  • Acne
  • Acne Scars - Mixed Atrophic and Hypertrophic
  • Scars
  • Wrinkle
  • Pigment; Lesion
  • Skin Texture Disorder
03

In context

Acne Vulgaris

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  1. Male or female subjects between 18 to 70 years of age.
  2. Dermatologic condition that can be addressed by the laser, including but not limited to:

    1. Wrinkles
    2. Scars
    3. Acne Scars
    4. Active Acne
    5. Dyschromia
    6. Cutaneous Lesions such as Age or Sun Spots
    7. Melasma
    8. Laxity
  3. Willingness to have digital photographs taken of treatment area(s) and agreement with use of photographs for presentation, educational, or marketing purposes.
  4. Willingness to comply with the following during the study, including the follow-up period:

    1. maintain consistent skin care regimen on treated areas.
    2. cover treated areas or have very limited sun exposure and, if requested, use an approved sunscreen of SPF 50 or higher.
    3. refrain from using systemic , according to Investigator discretion.
    4. refrain from using topical corticosteroids, retinoids, or prescription skin-lightening medications on the treated areas, according to Investigator discretion.
    5. refrain from any other procedures in the treatment areas.
  5. Willingness and ability to comply with study instructions and return for required visits.
  6. Subject has read and signed a written form.
  7. Subject lives within 50 miles of study site.
  8. Willingness to shave hair in intended treatment area

Exclusion criteria

Exclusion Criteria:

  1. Skin pathology or condition that could interfere with evaluation of the study procedure, e.g.,
  2. Systemic treatment prescribed within previous 6 months (e.g., oral medication such as isotretinoin)
  3. Surgical treatment in the target areas within previous 6 months (e.g., laser surgery)
  4. Active vitiligo, psoriasis, or eczema in the treatment area
  5. Injection of dermal filler in the target areas within previous 1 month (e.g., collagen, hyaluronic acid filler)
  6. Cosmetic procedures in the target areas within prior 3 months (e.g., laser, microdermabrasion, skin peel)
  7. Topical treatment applied to target areas within the previous 1 month or according to Investigator discretion.
  8. Active suntan and unable or unlikely to refrain from tanning within the follow-up period.
  9. 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.
  10. Active localized or systemic infection, or an open wound in area being treated.
  11. Lesions in the treatment areas suspicious for (skin cancer, melanoma)
  12. History of abnormal wound healing or abnormal scarring (e.g., hypertrophic or keloid)
  13. History of connective tissue disease, such as lupus or scleroderma.
  14. 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).
  15. History of gold therapy.
  16. 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.
  17. History of radiation to the treatment area or currently undergoing systemic chemotherapy for the treatment of cancer.
  18. For Female: Pregnancy or lactation, or intent to become pregnant within the study period.
  19. Significant uncontrolled concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
  20. History of /immune deficiency disorder or currently using immunosuppressive medications.
  21. Current enrollment in a clinical study of any other unapproved drug or device
  22. 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.
Terms in these criteria, in plain language(5)

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.

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.

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.

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Intervention

    Subjects treated with the AVAVA Device

    Device: AVAVA

Interventions

  • DeviceAVAVA

    1550nm Non-Ablative Fractional Laser

06

What researchers measure

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

  5. 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

  6. 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

07

Study locations

1 of 1 sites recruiting
  • AVAVA, Inc.
    Waltham, Massachusetts 02451, United States
    Recruiting
08

References and documents

Individual participant data

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Mar 6, 2025
First posted
Mar 11, 2025
StartActual
Sep 11, 2024
Primary completionEst.
Dec 30, 2027
CompletionEst.
Dec 30, 2027
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06868615
Lead sponsor
AVAVA, Inc.
Responsible party
Sponsor
First posted
Mar 11, 2025
Start date
Sep 11, 2024
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Sep 15, 2026

Study contacts

Alexander Denis
Contact
studies@avavaskin.com
6176936669

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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