Acne, Brown Spots, Facial Wrinkles, Infraorbital Dark Circle Severity, Porphyrins, Red Spots, Skin Ageing, Skin Elasticity, Skin Firmness, Skin Pores, Skin Texture, UV Spots
Conditions
Keywords
NIRA, Facial Wrinkles, Wrinkles, Full-Face Wrinkles, 1450 nm, 1450 nm laser, Fitzpatrick Wrinkle Scale, Acne
Brief 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.
Detailed description
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.
Interventions
DEVICENIRA 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.
OTHERTopical
Topical skincare formulation designed for twice daily, full-face application. Used in Arm 2 only in addition to the NIRA Laser M2.1.
Sponsors
NIRA Innovations Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Primary endpoint assessment was performed by 3 blinded evaluators using before and after treatment photographs. The evaluators were blinded to image order.
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ARM 1 and ARM 2: Full Face Wrinkle Effectiveness Primary Endpoint a) | 28 weeks | 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. |
| ARM 1 and ARM 2: Full Face Wrinkle Safety Primary Endpoint b) | 28 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ARM 1 and ARM 2: Full-Face Wrinkle Subject Satisfaction Secondary Endpoint | 16 weeks | The secondary endpoint will be participant satisfaction, as determined by a post-treatment questionnaire. |
| ARM 1 and ARM 2: Change From Baseline in Infraorbital Dark Circle Severity | 28 weeks | 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. |
| ARM 1 and ARM 2: Change From Baseline in Skin Elasticity | 28 Weeks | 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. |
| ARM 1 and ARM 2: Change From Baseline in Skin Firmness | 28 weeks | 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. |
Countries
United States
Outcome results
None listed