AVAVA SR-1 Wrinkles and BPL Study (NCT04925921) | Clinical Trial Compass
CompletedNot Applicable
AVAVA SR-1 Wrinkles and BPL Study
United States20 participantsStarted 2021-05-10
Plain-language summary
This study is being conducted to evaluate the safety and efficacy of a laser called the SR-1 Skin Treatment System, or SR-1 Laser, for the treatment of wrinkles and pigmented spots. Participants will be treated with the SR-1 Laser 3 or 4 times with each treatment spaced 4-6 weeks apart. The improvement in wrinkles and pigmented spots will be evaluated 1 and 3 months after the final treatment.
Who can participate
Age range
22 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Wrinkles on both sides of the face (e.g., peri-oral, peri-orbital, and cheek) scored 4-9 on the Fitzpatrick Wrinkle and Elastosis Scale
. Willingness to have both sides of the face exposed to the SR-1 Laser.
. Willingness to have digital photographs taken of their face and agreement with use of photographs, with their identity protected, 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 use a provided sunscreen as directed by the Investigator
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. refrain from using systemic or topical skin-lightening medications or retinoids
Exclusion criteria
. Skin pathology or condition, or medication use that could interfere with evaluation of the study procedure, e.g.,
. Isotretinoin use within previous 6 months
. Surgical treatment in the target areas within previous 6 months
. Active vitiligo, psoriasis, or eczema, or history of these in the treatment area
. Injection of botulinum toxin in the treatment areas within the previous 3 months.
. Facial cosmetic procedures in the target areas within previous 6 months (e.g., laser or other energy-based device treatment, microdermabrasion, microneedling, chemical peel, injection of dermal filler).
. Current smoker or history of smoking greater than 0.5 pack/day in past 5 years.
. Excessive sun exposure in the previous month, or unable or unlikely to refrain from tanning or excessive sun exposure during the study.