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 range22 Years – 70 Years
SexALL
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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
✓. refrain from using systemic corticosteroids
✓. 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.