Actively Recruiting
AVAVA MIRIA General Use
Led by AVAVA, Inc. · Updated on 2025-03-11
200
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A general protocol to treat a variety of dermatologic conditions and collect patient feedback. Primary outcome is the collection and analysis of patient questionnaires related to the overall experience of the device treatment. Secondary outcome measures include physician and subject evaluations in regards to improvement seen in the device as well as assessment of side effects.
CONDITIONS
Official Title
AVAVA MIRIA General Use
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects between 18 to 70 years of age.
- Dermatologic condition that can be addressed by the laser, including wrinkles, scars, acne scars, active acne, dyschromia, cutaneous lesions such as age or sun spots, melasma, or skin laxity.
- Willingness to have digital photographs taken of treatment area(s) and agree to use of photographs for presentation, educational, or marketing purposes.
- Willingness to maintain consistent skin care regimen on treated areas during the study.
- Willingness to limit sun exposure and use an approved sunscreen of SPF 50 or higher if requested.
- Willingness to refrain from using systemic corticosteroids as directed by the Investigator.
- Willingness to refrain from using topical corticosteroids, retinoids, or prescription skin-lightening medications on treated areas as directed.
- Willingness to refrain from any other procedures in the treatment areas during the study.
- Willingness and ability to comply with study instructions and attend required visits.
- Subject has read and signed a written informed consent form.
- Subject lives within 50 miles of study site.
- Willingness to shave hair in intended treatment area.
You will not qualify if you...
- Skin pathology or condition that could interfere with evaluation of the study procedure.
- Systemic treatment prescribed within previous 6 months (e.g., oral isotretinoin).
- Surgical treatment in the target areas within previous 6 months (e.g., laser surgery).
- Active vitiligo, psoriasis, or eczema in the treatment area.
- Injection of dermal filler in target areas within previous 1 month (e.g., collagen, hyaluronic acid).
- Cosmetic procedures in target areas within prior 3 months (e.g., laser, microdermabrasion, skin peel).
- Topical treatment applied to target areas within previous 1 month or as per Investigator discretion.
- Active suntan and unable or unlikely to refrain from tanning during follow-up.
- Artificial tanning in target areas within previous 1 month or intention to use during follow-up.
- Active localized or systemic infection, or open wound in treatment area.
- Lesions suspicious for malignancy in treatment areas.
- History of abnormal wound healing or abnormal scarring.
- History of connective tissue disease such as lupus or scleroderma.
- Use of medication increasing sensitivity to light as per Investigator discretion.
- History of gold therapy.
- History of heat-stimulated disease such as recurrent herpes simplex or zoster in treatment area unless prophylactically treated.
- History of radiation to treatment area or current systemic chemotherapy.
- For females: pregnancy, lactation, or intent to become pregnant during study.
- Significant uncontrolled illness such as diabetes or cardiovascular disease.
- History of immunosuppression or current use of immunosuppressive medications.
- Current enrollment in another clinical study of unapproved investigational drug or device.
- Any condition or lab value that may affect participation or pose unacceptable risk as judged by investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
AVAVA, Inc.
Waltham, Massachusetts, United States, 02451
Actively Recruiting
Research Team
A
Alexander Denis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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