AV-23-001 AVAVA MIRIA Pilot Study (NCT06557434) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
AV-23-001 AVAVA MIRIA Pilot Study
United States200 participantsStarted 2023-11-06
Plain-language 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 scars). The study is also intended to assist in determination of the optimal laser configuration and treatment parameters that most consistently yield results.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
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. The timing of use of fillers, neuromodulators and other cosmetic procedures are at the discretion of the investigator.
✕6. Topical treatment applied to target areas within the previous 1 month or according to Investigator discretion.
✕7. Active suntan and unable or unlikely to refrain from tanning within the follow-up period.
✕8. 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.