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Recruiting

NCT Number: NCT06868615

AVAVA MIRIA General Use

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AVAVA, Inc.

Waltham, Massachusetts, 02451, United States

Location status: Recruiting

Location contact

Alexander Denis

CONTACT

[email protected]

617-693-6669

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects between 18 to 70 years of age.
  • Dermatologic condition that can be addressed by the laser, including but not limited to:
  • Wrinkles
  • Scars
  • Acne Scars
  • Active Acne
  • Dyschromia
  • Cutaneous Lesions such as Age or Sun Spots
  • Melasma
  • Laxity
  • Willingness to have digital photographs taken of treatment area(s) and agreement with use of photographs for presentation, educational, or marketing purposes.
  • Willingness to comply with the following during the study, including the follow-up period:
  • maintain consistent skin care regimen on treated areas.
  • cover treated areas or have very limited sun exposure and, if requested, use an approved sunscreen of SPF 50 or higher.
  • refrain from using systemic corticosteroids, according to Investigator discretion.
  • refrain from using topical corticosteroids, retinoids, or prescription skin-lightening medications on the treated areas, according to Investigator discretion.
  • refrain from any other procedures in the treatment areas.
  • Willingness and ability to comply with study instructions and return for 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

Exclusion criteria

  • Skin pathology or condition that could interfere with evaluation of the study procedure, e.g.,
  • Systemic treatment prescribed within previous 6 months (e.g., oral medication such as 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 the target areas within previous 1 month (e.g., collagen, hyaluronic acid filler)
  • Cosmetic procedures in the target areas within prior 3 months (e.g., laser, microdermabrasion, skin peel)
  • Topical treatment applied to target areas within the previous 1 month or according to Investigator discretion.
  • Active suntan and unable or unlikely to refrain from tanning within the follow-up period.
  • 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.
  • Active localized or systemic infection, or an open wound in area being treated.
  • Lesions in the treatment areas suspicious for malignancy (skin cancer, melanoma)
  • History of abnormal wound healing or abnormal scarring (e.g., hypertrophic or keloid)
  • History of connective tissue disease, such as lupus or scleroderma.
  • 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).
  • History of gold therapy.
  • 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.
  • History of radiation to the treatment area or currently undergoing systemic chemotherapy for the treatment of cancer.
  • For Female: Pregnancy or lactation, or intent to become pregnant within the study period.
  • Significant uncontrolled concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
  • History of immunosuppression/immune deficiency disorder or currently using immunosuppressive medications.
  • Current enrollment in a clinical study of any other unapproved investigational drug or device
  • 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.

Treatment and study plan

AVAVA

Device

1550nm Non-Ablative Fractional Laser

Primary outcomes

  1. Completion of Post-Treatment Subject Questionnaire

    Time frame: Immediate Post-Treatment

    Post-treatment questionnaire to evaluate the overall patient experience including descriptions of the treatment session and overall patient experience.

Secondary outcomes

  1. Blinded Assessment of Before and After Imaging by Trained Dermatologist

    Time frame: Baseline, 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment

    Subject images will be placed in a randomized order and blinded graders will be asked to identify the post-treatment image.

  2. Completion of Follow-Up Subject Questionnaire

    Time frame: 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment

    Questionnaire evaluates the subject evaluated results of the study including questions related to the device such as whether or not they would participate in additional treatments or recommend the procedure to friends/family

  3. Physician Rated Satisfaction

    Time frame: Baseline, 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment

    Percentage of subject results that treating physician was satisfied with at end of study.

    Physician Rated satisfaction with included options of Very Satisfied, Satisfied, Slightly Satisfied, Neutral, Dissatisfied.

  4. Subject Rated Satisfaction

    Time frame: Baseline, 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment

    Percentage of subjects satisfied with their results at end of study. Subject Rated satisfaction with included options of Very Satisfied, Satisfied, Slightly Satisfied, Neutral, Dissatisfied.

  5. Physician Rated Global Clinical Aesthetic Improvement Scale Scoring

    Time frame: Baseline, 3 Months Post Final Treatment, 6 Months Post Final Treatment, 12 Months Post Final Treatment

    Physician will be asked to rate subject improvement on a 5 point scale. 0 - Worsened, 1-No Change, 2-Minor Improvement, 3-Moderate Improvement, 4-Significant Improvement

  6. Subject tolerance of procedure based on pain score during treatment per Visual Analogue Scale

    Time frame: Immediate Post Treatment

    Subjects are asked to rate their pain scores from 0 (No pain) to 10 (worst imaginable pain)

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Denis

CONTACT

[email protected]

6176936669

Sponsors and collaborators

Lead sponsor

AVAVA, Inc.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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