Clinical Study Evaluating the Safety and Effectiveness of the NIRA Laser M2.1 for the Treatment of Full-Face Wrinkles

NIRA™ Laser M2.1 and Topical Treatment of Full-Face Wrinkles: A CLINICAL TRIAL

This clinical trial evaluated the safety and effectiveness of the NIRA Laser M2.1, with or without a topical treatment, for the treatment of full-face wrinkles in adults. Participants were assigned to one of two treatment arms: laser-only treatment or laser treatment followed by topical treatment. Wrinkle improvement was assessed using standardized facial photographs reviewed by blinded evaluators, and participant satisfaction and safety observations were also assessed.

This was a non-randomized, open-label, two-arm clinical study evaluating the NIRA Laser M2.1, with or without topical treatment, for treatment of full-face wrinkles in adults.

Participants were assigned to one of two study arms. Participants in Arm 1 received laser-only treatment. Participants in Arm 2 received laser treatment followed by topical treatment.

The study evaluated within-participant change from baseline in facial wrinkles using standardized before-and-after facial photographs reviewed by three blinded evaluators. Safety observations, including adverse events, participant satisfaction, and other facial observations were also assessed.

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