Actively Recruiting
AVAVA MIRIA General Use Laser Treatment for Various Dermatologic Conditions
Led by AVAVA, Inc. · Updated on 2025-03-11
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of the AVAVA Device, a 1550nm Non-Ablative Fractional Laser, to treat various dermatologic conditions including acne, acne scars, wrinkles, pigment lesions, and skin texture disorders. The study aims to collect and analyze patient feedback on their overall experience with the device treatment. The primary focus is on responses to post-treatment questionnaires, while secondary measures include evaluations by physicians and patients regarding improvements and side effects. Participants will receive treatment using the AVAVA Device targeting their dermatologic condition. The study includes follow-up periods at 3, 6, and 12 months after the final treatment to assess outcomes. During these times, trained dermatologists will review before and after images, and both physicians and subjects will complete satisfaction and clinical improvement scales. The treatment process involves digital photography and adherence to specific skincare and sun exposure guidelines. Throughout the study, participants will complete questionnaires immediately after treatment and during follow-up visits to report their experience and tolerance of the procedure, including pain levels. Researchers will monitor the skin's response and improvements over time through imaging and clinical assessments. The study requires participants to comply with study instructions, maintain consistent skincare, and attend scheduled visits. The total participation duration spans from initial treatment through 12 months of follow-up.
CONDITIONS
Brief 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 addressable by the laser, including wrinkles, scars, acne scars, active acne, dyschromia, cutaneous lesions like age or sun spots, melasma, or laxity
- Willingness to have digital photographs taken and agree to their use for presentation, education, or marketing
- Willingness to maintain consistent skin care on treated areas and limit sun exposure or use SPF 50+ sunscreen as requested
- Willingness to avoid systemic corticosteroids, topical corticosteroids, retinoids, or prescription skin-lightening medications on treated areas as directed
- Willingness to avoid other procedures on treated areas during the study
- Ability and willingness to follow study instructions and attend required visits
- Signed informed consent form
- Residence within 50 miles of the study site
- Willingness to shave hair in the intended treatment area
You will not qualify if you...
- Skin conditions that interfere with study evaluation
- Use of systemic treatment such as oral isotretinoin within the previous 6 months
- Surgical treatment in target areas within the previous 6 months
- Active vitiligo, psoriasis, or eczema in the treatment area
- Dermal filler injections in target areas within the previous 1 month
- Cosmetic procedures like laser, microdermabrasion, or skin peels in target areas within 3 months
- Topical treatments applied to target areas within the previous 1 month or as directed
- Active suntan or inability to avoid tanning during follow-up
- Artificial tanning in target areas within the previous 1 month or planned during follow-up
- Active localized or systemic infection or open wound in treatment area
- Suspicious lesions for malignancy in treatment area
- History of abnormal wound healing or scarring such as hypertrophic or keloid
- History of connective tissue diseases like lupus or scleroderma
- Use of medications increasing light sensitivity as directed
- History of gold therapy
- History of heat-stimulated diseases like recurrent herpes simplex or shingles in treatment area unless prophylactic treatment is given
- History of radiation to treatment area or current systemic chemotherapy for cancer
- Pregnancy, lactation, or intent to become pregnant during study for females
- Significant uncontrolled illnesses such as diabetes or cardiovascular disease
- History or current use of immunosuppressive medications
- Current participation in other clinical trials of unapproved drugs or devices
- Any other condition or lab value judged by the investigator to affect study participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Not specified
Participants receive treatment with the AVAVA 1550nm Non-Ablative Fractional Laser device for various dermatologic conditions.
1 treatment visit (in-person)
Duration - Up to 12 months post final treatment
Participants complete follow-up assessments including questionnaires, imaging, and physician and subject rated satisfaction at multiple timepoints after the final treatment.
Visits at 3, 6, and 12 months post final treatment
Trial Site Locations
Total: 1 location
1
AVAVA, Inc.
Waltham, Massachusetts, United States, 02451
Actively Recruiting
Research Team
A
Alexander Denis
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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