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

NCT07572331 | Completed FDA Device

• 2 other identifiers: DP-100320244922
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Ageing; Facial Wrinkles; Acne; Skin Elasticity; Infraorbital Dark Circle Severity; Skin Firmness; UV Spots; Skin Texture; Skin Pores; Brown Spots; Porphyrins; Red Spots

Keywords

NIRA; Facial Wrinkles; Wrinkles; Full-Face Wrinkles; 1450 nm; 1450 nm laser; Fitzpatrick Wrinkle Scale; Acne

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• ARM 1 and ARM 2: Full-Face Wrinkle Subject Satisfaction Secondary Endpoint

  16 weeks

• ARM 1 and ARM 2: Change From Baseline in Infraorbital Dark Circle Severity

  28 weeks

• ARM 1 and ARM 2: Change From Baseline in Skin Elasticity

  28 Weeks

• ARM 1 and ARM 2: Change From Baseline in Skin Firmness

  28 weeks

Study Arms (2)

NIRA Laser M2.1

EXPERIMENTAL

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

NIRA Laser M2.1 Followed by Topical Treatment

OTHER

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; Other: Topical

Interventions

NIRA Laser M2.1 DEVICE

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.

NIRA Laser M2.1; NIRA Laser M2.1 Followed by Topical Treatment

Topical OTHER

Topical skincare formulation designed for twice daily, full-face application. Used in Arm 2 only in addition to the NIRA Laser M2.1.

NIRA Laser M2.1 Followed by Topical Treatment

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NIRA Innovations Inc.: lead

Study Sites (1)

Northeast Dermatology Associates

Beverly, Massachusetts, 01915, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Primary endpoint assessment was performed by 3 blinded evaluators using before and after treatment photographs. The evaluators were blinded to image order.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 7, 2026
• Study Start: January 13, 2025
• Primary Completion: October 21, 2025
• Study Completion: October 21, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)