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Clinical Study Evaluating the Safety and Effectiveness of the NIRA Laser M2.1 for the Treatment of Full-Face Wrinkles
Sponsor: NIRA Innovations Inc.
Summary
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.
Official title: NIRA™ Laser M2.1 and Topical Treatment of Full-Face Wrinkles: A CLINICAL TRIAL
Key Details
Gender
All
Age Range
35 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-01-13
Completion Date
2025-10-21
Last Updated
2026-05-07
Healthy Volunteers
No
Conditions
Interventions
NIRA Laser M2.1
Hand-held OTC 1450nm diode laser device for full-face wrinkle treatment. Subjects treated themselves privately in their own homes, daily, per the Instructions for Use.
Topical
Topical skincare formulation designed for twice daily, full-face application. Used in Arm 2 only in addition to the NIRA Laser M2.1.
Locations (1)
Northeast Dermatology Associates
Beverly, Massachusetts, United States