BridgeMD
New treatment option for Acne
Official title AVAVA MIRIA General Use
ClinicalTrials.gov ID: NCT06868615
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Male or female people 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
You likely can't join if
- 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)
See the full eligibility criteria
- Male or female people 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Waltham, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Waltham, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.