AV-23-001 AVAVA MIRIA Pilot Study

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

10 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Male or female subjects \> 18 years of age.
2. Dermatologic condition currently indicated for laser treatment OR the subject is to be enrolled for assessment of treatment parameters on normal skin.
3. Willingness to have multiple areas exposed.
4. Willingness to have digital photographs taken of treatment area(s) and agreement with use of photographs for presentation, educational, or marketing purposes.
5. Willingness to comply with the following during the study, including the follow-up period:

1. maintain consistent skin care regimen on treated areas.
2. Willingness to 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 corticosteroids, 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.
6. Willingness and ability to comply with study instructions and return for required visits.
7. 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.
8. Subject has read and signed a written informed consent form.
9. Subject lives within 50 miles of study site.
10. For Males: Willingness to shave facial hair on treatment areas.

Exclusion Criteria:
11. Skin pathology or condition that could interfere with evaluation of the study procedure, e.g.,
12. Systemic treatment prescribed within previous 6 months (e.g., oral medication such as isotretinoin)
13. Surgical treatment in the target areas within previous 6 months (e.g., laser surgery)
14. Active vitiligo, psoriasis, or eczema in the treatment area
15. The timing of use of fillers, neuromodulators and other cosmetic procedures are at the discretion of the investigator.
16. Topical treatment applied to target areas within the previous 1 month or according to Investigator discretion.
17. Active suntan and unable or unlikely to refrain from tanning within the follow-up period.
18. 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.
19. Active localized or systemic infection, or an open wound in area being treated.
20. Lesions in the treatment areas suspicious for malignancy (skin cancer, melanoma)
21. History of abnormal wound healing or abnormal scarring (e.g., hypertrophic or keloid)
22. History of connective tissue disease, such as lupus or scleroderma.
23. 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).
24. History of gold therapy.
25. 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.
26. History of radiation to the treatment area or currently undergoing systemic chemotherapy for the treatment of cancer.
27. For Female: Pregnancy or lactation, or intent to become pregnant within the study period.
28. Significant uncontrolled concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
29. History of immunosuppression/immune deficiency disorder or currently using immunosuppressive medications.
30. 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.
31. 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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (2)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

2 locations

Study team and timeline

Lead sponsor

AVAVA, Inc.

Study start

Nov 6, 2023 Actual

Primary completion

Jul 3, 2024 Actual

Study completion

Jul 3, 2024 Actual

First posted

Aug 16, 2024 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.