AVAVA MIRIA General Use

Launched by AVAVA, INC. · Mar 6, 2025

Keywords

ClinConnect Summary

The AVAVA MIRIA General Use trial is looking at a new treatment option for various skin conditions, such as acne, acne scars, wrinkles, and skin discolorations. The main goal of the study is to gather feedback from patients about their experiences with this treatment, including how effective it is and any side effects they may notice. The trial is currently recruiting participants aged 18 to 70, who have skin issues that can be treated with a laser device.

If you decide to take part in this study, you will need to commit to following certain care instructions during and after the treatment, including avoiding sun exposure and specific skin products. You will also have your treatment area photographed for research purposes. It’s important to note that certain health conditions or recent treatments may disqualify you from participating, so discussing your medical history with the study team is essential. This trial provides a chance to explore a treatment for common skin concerns while contributing to important research.

Gender

ALL

Eligibility criteria

• 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 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.
• • 5. Willingness and ability to comply with study instructions and return for required visits.
• • 6. Subject has read and signed a written informed consent form.
• • 7. Subject lives within 50 miles of study site.
• • 8. Willingness to shave hair in intended treatment area
• 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 malignancy (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 immunosuppression/immune deficiency disorder or currently using immunosuppressive medications.
• • 21. Current enrollment in a clinical study of any other unapproved investigational 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.