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Completed

NCT Number: NCT07572331

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

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.

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Key information

Conditions

Skin Ageing Acne Acne Vulgaris Acneiform Eruptions Brown Spots Facial Wrinkles Infraorbital Dark Circle Severity Porphyrins Red Spots Sebaceous Gland Diseases Skin Diseases Skin Elasticity Skin Firmness Skin Pores Skin Texture Skin and Connective Tissue Diseases UV Spots

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northeast Dermatology Associates

Beverly, Massachusetts, 01915, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. ARM 1 and ARM 2: Full Face Wrinkle Effectiveness Primary Endpoint a)

    Time frame: 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.

  2. ARM 1 and ARM 2: Full Face Wrinkle Safety Primary Endpoint b)

    Time frame: 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 outcomes

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

    Time frame: 16 weeks

    The secondary endpoint will be participant satisfaction, as determined by a post-treatment questionnaire.

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

    Time frame: 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.

  3. ARM 1 and ARM 2: Change From Baseline in Skin Elasticity

    Time frame: 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.

  4. ARM 1 and ARM 2: Change From Baseline in Skin Firmness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NIRA Innovations Inc.

Industry

Registry information

Official study title

NIRA™ Laser M2.1 and Topical Treatment of Full-Face Wrinkles: A CLINICAL TRIAL

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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