What is the AVAVA Device studying for skin conditions?

The AVAVA Device is being studied for its use in treating various skin conditions like acne, scars, wrinkles, and pigmentation issues. Researchers aim to understand patient experiences and clinical outcomes after treatment using this laser device. The study is sponsored by AVAVA, Inc., to evaluate how the device impacts skin appearance and patient satisfaction.

Who may be eligible for this dermatology clinical trial?

Adults aged 18 to 70 with dermatologic conditions such as wrinkles, scars, acne, or pigment lesions may be eligible. Both males and females can participate if they agree to study procedures and follow skincare guidelines. Please review eligibility criteria for more details.

Is there any cost to participate in this skin treatment clinical trial?

Study-related care, including the device treatment and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to attending visits may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 70Years

All Genders

Healthy Volunteers

ID06868615

AVAVA MIRIA General Use Laser Treatment for Various Dermatologic Conditions

Led by AVAVA, Inc. · Updated on 2025-03-11

200

Participants Needed

Research Sites

N/A

Total Duration

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 skins 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

Age: 18Years - 70Years

All Genders

Healthy Volunteers

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

Research Team

Alexander Denis

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