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Procedure

MIRIA Skin Treatment for Wrinkles and Scars

N/A
Recruiting
Led By Hyemin Pomerantz, MD
Research Sponsored by AVAVA, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Dermatologic condition currently indicated for laser treatment OR the subject is to be enrolled for assessment of treatment parameters on normal skin
Willingness to refrain from using systemic corticosteroids, topical corticosteroids, retinoids, or prescription skin-lightening medications on the treated areas
Must not have
Active localized or systemic infection, or an open wound in area being treated
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to show how the MIRIA Skin Treatment System can help improve skin conditions like pigmented lesions, wrinkles, and scars that are typically treated with lasers. The study will also help determine

Who is the study for?
This trial is for individuals with skin conditions like Cutis Laxa, acne scars, pigmented lesions, loose skin, scarring, and wrinkles. Participants should be seeking improvement in these areas using the MIRIA Skin Treatment System.
What is being tested?
The AVAVA MIRIA Pilot Study is testing the effectiveness of the MIRIA Skin Treatment System on various dermatologic conditions that are typically treated with lasers. The study aims to find the best laser settings and treatment methods.
What are the potential side effects?
While specific side effects are not listed here, similar laser treatments may cause redness, swelling, discomfort at the site of treatment or changes in skin pigmentation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need laser treatment for a skin condition or for assessing normal skin.
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I am willing to avoid using certain skin treatments on the areas being studied.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an infection or an open wound in the area that needs treatment.
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I haven't used artificial tanning on target areas in the last month and don't plan to during the study.
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I have had radiation or am on chemotherapy for cancer.
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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.
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I do not have uncontrolled illnesses like diabetes or heart disease.
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I do not have any skin conditions that could affect study evaluations.
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I have not had surgery in the affected area in the last 6 months.
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I have active vitiligo, psoriasis, or eczema in the area to be treated.
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I have suspicious skin lesions in the areas to be treated.
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I have a history of abnormal wound healing or scarring.
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I have been treated with gold therapy in the past.
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I have had shingles or cold sores in the area to be treated, but can follow a preventive treatment plan.
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I have an immune system disorder or am taking medication that weakens my immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Global Aesthetic Improvement Scale (GAIS)
Secondary study objectives
Adverse Event Assessment
Subject Questionnaire

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treated CohortExperimental Treatment1 Intervention
Experimental: Treatment with the MIRIA Laser 3-4 experimental treatments at 4-6 week intervals. Refine usage of device

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Who is running the clinical trial?

AVAVA, Inc.Lead Sponsor
2 Previous Clinical Trials
95 Total Patients Enrolled
Hyemin Pomerantz, MDPrincipal InvestigatorAVAVA, Inc.
~15 spots leftby Dec 2024
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