NCT06868615 · AVAVA, Inc.
AVAVA MIRIA General Use
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- Active Acne
- Cutaneous Lesions such as Age or Sun Spots
- 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.
Where
- Waltham, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2025 · Source of record for eligibility and locations