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WrinkleNCT06557434

AV-23-001 AVAVA MIRIA Pilot Study

A study testing MIRIA in people with Wrinkle and Acne Scars - Mixed Atrophic and Hypertrophic, run by AVAVA, Inc. at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This non-significant risk study is intended to demonstrate the use of the MIRIA Skin Treatment System can show improvement in dermatologic conditions currently indicated for treatment with a laser (such as, but not limited to, benign pigmented lesions, benign cutaneous lesions, wrinkles, textural irregularities, or… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
MIRIA
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesUnited States
Study dates
6 Nov 2023to 31 Dec 2026
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female subjects > 18 years of age.
  • Dermatologic condition currently indicated for laser treatment OR the subject is to be enrolled for assessment of treatment parameters on normal skin.
  • Willingness to have multiple areas exposed.
  • 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.
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  • Willingness to 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 understands that fees will be collected at the time of treatment ranging from $300 to $3000 per treatment depending upon number of anatomical areas treated. The exact amount will be disclosed and recorded within the consent.
  • Subject has read and signed a written informed consent form.
  • Subject lives within 50 miles of study site.
  • For Males: Willingness to shave facial hair on treatment areas.

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
  • The timing of use of fillers, neuromodulators and other cosmetic procedures are at the discretion of the investigator.
  • Topical treatment applied to target areas within the previous 1 month or according to Investigator discretion.
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  • 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 unless it is a noninvasive dermal study for which the subject is in a follow-up period and has other areas of skin that meet the study criteria or has received an investigational drug or been treated with an investigational device within 30 days prior to entering this study.
  • 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

2 sites in 1 country.

United States2 sites

  • Skinfluence Long Island

    Dix Hills, New York, 11746

  • Laser and Skin Surgery Center of New York

    New York, New York, 10010

Other trials in United States

About this study

This non-significant risk study is intended to demonstrate the use of the MIRIA Skin Treatment System can show improvement in dermatologic conditions currently indicated for treatment with a laser (such as, but not limited to, benign pigmented lesions, benign cutaneous lesions, wrinkles, textural irregularities, or scars). The study is also intended to assist in determination of the optimal laser configuration and treatment parameters that most consistently yield results.

Read the detailed description

This study is intended to allow clinical evaluation of the feasibility of the MIRIA Skin Treatment System, referred to herein as the SR Skin Rejuvenation Laser, for the treatment of dermatologic conditions currently indicated for treatment with a laser (such as, but not limited to, benign pigmented lesions, benign cutaneous lesions, wrinkles, textural irregularities, or scars). This clinical evaluation is being performed under an investigational protocol to formally collect data for the treatment of different dermatologic conditions.

This prospective, non-randomized, controlled study will include subjects with dermatologic conditions that are currently indicated for treatment with a laser who are willing to have sites exposed to the MIRIA Laser and who agree to comply with the study requirements during the follow-up period, a minimum of 3 months and a maximum of 18 months. Some areas with the dermatologic condition may be left as a control for the treated section. Subjects may also be directed to use some topical cream or lotion for up to 1 month prior to the laser procedure or during the duration of the study, according to the Investigator's standard practice.

Being tested
MIRIA
Keywords
MIRIA, Laser, Wrinkles, Acne Scars, Skin Laxity, Skin Improvement, non-ablative
Medical subject headings
Hypertrophy, Cutis Laxa, Cicatrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MIRIADevice

    The MIRIA Skin Treatment System is a 1550nm-based laser system indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

Study groups in NCT06557434
Study groupRoleWhat they receive
Treated CohortExperimentalExperimental: Treatment with the MIRIA Laser 3-4 experimental treatments at 4-6 week intervals. Refine usage of device
Receives: Device: MIRIA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global Aesthetic Improvement Scale (GAIS)

    Scale used to compare before and after images of subjects treated. Scores include the following:

    1. - Very Much Improved
    2. - Much Improved
    3. - Improved
    4. - No Change
    5. - Worse

    Measured: 3 Months

Secondary outcomes (2)

  1. Subject Questionnaire

    Questionnaire that evaluates the subjects impression of the treatment (overall discomfort score, satisfaction with treatment results, notes on treatment sensation).

    Measured: Immediate Post Treatment, 3 Months Post Treatment

  2. Adverse Event Assessment

    An assessment of side effects and adverse event profile to ensure safety of treatment. Data collected included the event, the duration, the severity, and any other interventions that may occur due to the adverse event.

    Measured: Immediate Post Treatment, 3 Months Post Treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2024
  2. Study start6 Nov 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06557434
Sponsor's protocol ID
AV-23-001
Status last verified
Mar 2025
First submitted
11 Dec 2023
Last updated
7 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MIRIA in people with Wrinkle and Acne Scars - Mixed Atrophic and Hypertrophic, run by AVAVA, Inc. at 2 sites 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 15 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Aesthetic Improvement Scale (GAIS) (time frame: 3 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06557434.

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 7 Mar 2025.

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