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

Part of paid clinical trials in Beverly, Massachusetts.

Sponsor
NIRA Innovations Inc.
Study ID
NCT07572331
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
35 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jan 13, 2025
Status verified
Mar 2026
Primary completion
Oct 21, 2025
Completion
Oct 21, 2025

Study Design

Enrollment
120 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).
  • 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.

Primary Outcome Measure

ARM 1 and ARM 2: Full Face Wrinkle Effectiveness Primary Endpoint a) [ Time Frame: 28 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northeast Dermatology AssociatesBeverlyMassachusetts01915-

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By research site
Northeast Dermatology Associates· Beverly, MA

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