AVAVA MIRIA General Use

Last updated: March 6, 2025
Sponsor: AVAVA, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acne

Scalp Disorders

Rash

Treatment

AVAVA

Clinical Study ID

NCT06868615
AV-24-003
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 limitedto:

  3. Wrinkles

  4. Scars

  5. Acne Scars

  6. Active Acne

  7. Dyschromia

  8. Cutaneous Lesions such as Age or Sun Spots

  9. Melasma

  10. Laxity

  11. Willingness to have digital photographs taken of treatment area(s) and agreementwith use of photographs for presentation, educational, or marketing purposes.

  12. Willingness to comply with the following during the study, including the follow-upperiod:

  13. maintain consistent skin care regimen on treated areas.

  14. cover treated areas or have very limited sun exposure and, if requested, use anapproved sunscreen of SPF 50 or higher.

  15. refrain from using systemic corticosteroids, according to Investigatordiscretion.

  16. refrain from using topical corticosteroids, retinoids, or prescriptionskin-lightening medications on the treated areas, according to Investigatordiscretion.

  17. refrain from any other procedures in the treatment areas.

  18. Willingness and ability to comply with study instructions and return for requiredvisits.

  19. Subject has read and signed a written informed consent form.

  20. Subject lives within 50 miles of study site.

  21. Willingness to shave hair in intended treatment area

Exclusion

Exclusion Criteria:

  1. Skin pathology or condition that could interfere with evaluation of the studyprocedure, e.g.,

  2. Systemic treatment prescribed within previous 6 months (e.g., oral medication suchas isotretinoin)

  3. Surgical treatment in the target areas within previous 6 months (e.g., lasersurgery)

  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 accordingto Investigator discretion.

  8. Active suntan and unable or unlikely to refrain from tanning within the follow-upperiod.

  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-upperiod.

  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 orkeloid)

  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 toInvestigator's discretion (e.g., topicals that produce sensitivity to light may beused 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 herpeszoster (shingles) in the treatment area, unless treatment is conducted following aprophylactic regimen.

  17. History of radiation to the treatment area or currently undergoing systemicchemotherapy for the treatment of cancer.

  18. For Female: Pregnancy or lactation, or intent to become pregnant within the studyperiod.

  19. Significant uncontrolled concurrent illness, such as diabetes mellitus orcardiovascular disease, e.g., uncontrolled hypertension.

  20. History of immunosuppression/immune deficiency disorder or currently usingimmunosuppressive medications.

  21. Current enrollment in a clinical study of any other unapproved investigational drugor device

  22. Any other condition or laboratory value that would, in the professional opinion ofthe investigator, potentially affect response or participation in this clinicalstudy, or would pose an unacceptable risk to the subject.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: AVAVA
Phase:
Study Start date:
September 11, 2024
Estimated Completion Date:
December 30, 2027

Connect with a study center

  • AVAVA, Inc.

    Waltham, Massachusetts 02451
    United States

    Active - Recruiting

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