AV-23-001 AVAVA MIRIA Pilot Study

NCT06557434 | Active Not Recruiting FDA Device

• 1 other identifier: AV-23-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Wrinkle; Acne Scars - Mixed Atrophic and Hypertrophic; Pigmented Lesions; Skin Laxity; Scars

Keywords

MIRIA; Laser; Wrinkles; Acne Scars; Skin Laxity; Skin Improvement; non-ablative

Outcome Measures

Primary Outcomes (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

  3 Months

Secondary Outcomes (2)

• Subject Questionnaire

  Immediate Post Treatment, 3 Months Post Treatment

• Adverse Event Assessment

  Immediate Post Treatment, 3 Months Post Treatment

Study Arms (1)

Treated Cohort

EXPERIMENTAL

Experimental: Treatment with the MIRIA Laser 3-4 experimental treatments at 4-6 week intervals. Refine usage of device

Device: MIRIA

Interventions

MIRIA DEVICE

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.

Treated Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AVAVA, Inc.: lead

Study Sites (2)

Skinfluence Long Island

Dix Hills, New York, 11746, United States

Location

Laser and Skin Surgery Center of New York

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Hypertrophy; Cutis Laxa; Cicatrix

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Fibrosis; Pathologic Processes

Study Officials

• Hyemin Pomerantz, MD

  AVAVA, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: August 16, 2024
• Study Start: November 6, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)