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.

Study Overview

• Status: Completed
• Conditions: Acne; Skin Elasticity; Facial Wrinkles; Skin Firmness; Skin Texture; Skin Ageing; Infraorbital Dark Circle Severity; UV Spots; Skin Pores; Brown Spots; Porphyrins; Red Spots
• Intervention / Treatment: Device: NIRA Laser M2.1; Other: Topical

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Northeast Dermatology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NIRA Laser M2.1; Arm 1: Laser only treatment for full face wrinkles. Subjects treated themselves privately in their own homes, daily. Continuous treatment was planned for the first 16 weeks. Endpoint visual assessments were taken at 4, 8, 12, 16, 20, 24 and 28 weeks. The total study participation time for each subject was approximately 28 weeks with visits at initiation plus at 4-week intervals (Visits 1 to 8).	Device: 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.
Other: NIRA Laser M2.1 Followed by Topical Treatment; Arm 2: Laser followed by topical treatment for full face wrinkles. Subjects treated themselves privately in their own homes, daily. Continuous treatment was planned for the first 16 weeks. Endpoint visual assessments were taken at 4, 8, 12, 16, and 28 weeks (Visits 1 to 5 and Visit 8). Visits 6 (20 weeks) and 7 (24 weeks) were not required for this arm. The total study participation time for each subject was approximately 28 weeks. This study will not disclose results of Arm 2 as the treatment in this arm includes a topical in addition to the laser device.	Device: 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.; Other: Topical; Topical skincare formulation designed for twice daily, full-face application. Used in Arm 2 only in addition to the NIRA Laser M2.1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	28 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	28 weeks

Collaborators and Investigators

• Sponsor: NIRA Innovations Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Actual): October 21, 2025
• Study Completion (Actual): October 21, 2025

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Acne; Wrinkles; Facial Wrinkles; NIRA; Full-Face Wrinkles; 1450 nm; 1450 nm laser; Fitzpatrick Wrinkle Scale
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Skin and Connective Tissue Diseases; Acne Vulgaris
• Other Study ID Numbers: DP-1003; 20244922 (Other Identifier: WCG IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study data are sponsor-controlled and include confidential participant-level clinical, photographic, device-use, and safety information. Summary-level study information may be reported as appropriate.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No