New laser shows promise for wrinkle reduction in clinical trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant is aged 35 years or older * Possesses valid photo ID * Willing to comply with all study requirements * Willing to take the device home for daily treatments * Willing to wear sunscreen when exposed to the sun * Willing to avoid wrinkle creams, microneedling, Botox, fillers, and similar cosmetic procedures during study participation * Willing to come to the office every four weeks for evaluation * Willing to be photographed and sign Information Release Consent * Willing to provide informed consent to participate * Fitzpatrick Skin Type grading I to VI * Fitzpatrick Wrinkle Scale grading of 4 or higher on a scale of 1 to 9 * Owns and regularly uses at least one email account * Willing to synchronize the NIRA device with the sponsor server monthly * Willing to log in to the sponsor web portal monthly to view usage history * Willing to read sponsor emails for feedback on study compliance * For female participants of childbearing potential: willing to use an acceptable form of birth control throughout the study, with consistent use for at least 30 days before study participation, and negative urine pregnancy test at baseline Exclusion Criteria: * Participant is pregnant, planning to be pregnant, undergoing fertility treatments, or nursing * Laser treatments on the face within the last 4 weeks * Severely immunocompromised state, such as AIDS, renal transplant regimens, immunosuppressed states consequent to malignancy or agents used in oncologic care, or end-stage renal disease * Psoriasis or lichen planus on the face * Microneedling, radiofrequency, fillers, or Botox treatments within study treatment areas in the past 3 months * If topical wrinkle agents such as tretinoin were used, participant must complete a 4-week washout period before starting the study protocol and be rescreened accordingly * Incapable adults who require enrollment by consent of a legally authorized representative