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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
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 skincare formulation designed for twice daily, full-face application. Used in Arm 2 only in addition to the NIRA Laser M2.1.
Northeast Dermatology Associates
Beverly, Massachusetts, United States
ARM 1 and ARM 2: Full Face Wrinkle Effectiveness Primary Endpoint a)
Effectiveness will be determined in the per-protocol participant population by comparing within-participant change-from-baseline using the Fitzpatrick Wrinkle Scale (1 to 9) for wrinkles. Primary endpoint assessment will be performed by three blinded evaluators from before and after treatment photographs (Visit 1 vs Visit 8). The independent evaluators will be dermatologists or professional dermatologist nurse practitioner, or equivalent, with understanding of the medical treatment of facial wrinkles. They will be blinded and will use standardized photographs and the Fitzpatrick Wrinkle Scale for their clinical assessment. For each individual participant, the change will be determined by the median scoring by 3 blinded evaluators.
Time frame: 28 weeks
ARM 1 and ARM 2: Full Face Wrinkle Safety Primary Endpoint b)
Safety assessed in the total enrolled participant population by evaluating types (severity, duration and resolution) and rates of adverse events, and their possible relationship to the treatment.
Time frame: 28 Weeks
ARM 1 and ARM 2: Full-Face Wrinkle Subject Satisfaction Secondary Endpoint
The secondary endpoint will be participant satisfaction, as determined by a post-treatment questionnaire.
Time frame: 16 weeks
ARM 1 and ARM 2: Change From Baseline in Infraorbital Dark Circle Severity
Infraorbital dark circle severity will be evaluated using standardized photographs and the validated 10-point Photonumeric Scale for Infraorbital Dark Circles (PSIDC). The PSIDC is graded from 0 to 9, with higher scores indicating greater infraorbital dark circle severity. Change from baseline to Visit 8 will be evaluated. A reduction in score compared with baseline indicates improvement.
Time frame: 28 weeks
ARM 1 and ARM 2: Change From Baseline in Skin Elasticity
Skin elasticity of facial skin will be assessed at the center of the left cheek using the ElastiMeter and recorded in Newtons per meter (N/m). Change from baseline to the final visit will be evaluated. A positive change from baseline indicates increased skin elasticity.
Time frame: 28 Weeks
ARM 1 and ARM 2: Change From Baseline in Skin Firmness
Skin firmness of facial skin will be assessed at the center of the left cheek using the Delfin Technologies SkinFibrometer and recorded in Newtons (N). Change from baseline to the final visit will be evaluated. A positive change from baseline indicates increased skin firmness.
Time frame: 28 weeks
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