Treatment for various skin conditions using AVAVA technology

AVAVA MIRIA General Use

This study is testing a new device called AVAVA to see if it can help improve skin problems like acne, scars, and wrinkles.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: AVAVA, Inc. (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Waltham, Massachusetts)
• Trial ID: NCT06868615 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of the AVAVA device in treating a range of dermatologic conditions, including acne, scars, and wrinkles. Participants will undergo treatment and provide feedback through questionnaires regarding their overall experience and any observed improvements. The study will also assess side effects and involve both physician and subject evaluations to gauge treatment outcomes. The goal is to gather comprehensive data on the device's performance across different skin issues.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with dermatologic conditions suitable for laser treatment.

Not a fit: Patients with contraindications to laser treatment or those not willing to comply with study protocols may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the appearance of various skin conditions for patients.

How similar studies have performed: While similar laser treatments have shown promise in dermatology, this specific approach with the AVAVA device is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Male or female subjects between 18 to 70 years of age.
2. Dermatologic condition that can be addressed by the laser, including but not limited to:

   1. Wrinkles
   2. Scars
   3. Acne Scars
   4. Active Acne
   5. Dyschromia
   6. Cutaneous Lesions such as Age or Sun Spots
   7. Melasma
   8. Laxity
3. Willingness to have digital photographs taken of treatment area(s) and agreement with use of photographs for presentation, educational, or marketing purposes.
4. Willingness to comply with the following during the study, including the follow-up period:

   1. maintain consistent skin care regimen on treated areas.
   2. cover treated areas or have very limited sun exposure and, if requested, use an approved sunscreen of SPF 50 or higher.
   3. refrain from using systemic corticosteroids, according to Investigator discretion.
   4. refrain from using topical corticosteroids, retinoids, or prescription skin-lightening medications on the treated areas, according to Investigator discretion.
   5. refrain from any other procedures in the treatment areas.
5. Willingness and ability to comply with study instructions and return for required visits.
6. Subject has read and signed a written informed consent form.
7. Subject lives within 50 miles of study site.
8. Willingness to shave hair in intended treatment area

Exclusion Criteria:

1. Skin pathology or condition that could interfere with evaluation of the study procedure, e.g.,
2. Systemic treatment prescribed within previous 6 months (e.g., oral medication such as isotretinoin)
3. Surgical treatment in the target areas within previous 6 months (e.g., laser surgery)
4. Active vitiligo, psoriasis, or eczema in the treatment area
5. Injection of dermal filler in the target areas within previous 1 month (e.g., collagen, hyaluronic acid filler)
6. Cosmetic procedures in the target areas within prior 3 months (e.g., laser, microdermabrasion, skin peel)
7. Topical treatment applied to target areas within the previous 1 month or according to Investigator discretion.
8. Active suntan and unable or unlikely to refrain from tanning within the follow-up period.
9. 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.
10. Active localized or systemic infection, or an open wound in area being treated.
11. Lesions in the treatment areas suspicious for malignancy (skin cancer, melanoma)
12. History of abnormal wound healing or abnormal scarring (e.g., hypertrophic or keloid)
13. History of connective tissue disease, such as lupus or scleroderma.
14. 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).
15. History of gold therapy.
16. 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.
17. History of radiation to the treatment area or currently undergoing systemic chemotherapy for the treatment of cancer.
18. For Female: Pregnancy or lactation, or intent to become pregnant within the study period.
19. Significant uncontrolled concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
20. History of immunosuppression/immune deficiency disorder or currently using immunosuppressive medications.
21. Current enrollment in a clinical study of any other unapproved investigational drug or device
22. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.

Where this trial is running

Waltham, Massachusetts

• AVAVA, Inc. — Waltham, Massachusetts, United States (RECRUITING)

Study contacts

• Study coordinator: Alexander Denis

Conditions: Acne, Acne Scars - Mixed Atrophic and Hypertrophic, Scars, Wrinkle, Pigment, Lesion, Skin Texture Disorder