CompletedNot Applicable

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

United States120 participantsStarted 2025-01-13

Plain-language 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.

Who can participate

Age range

35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 c…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 28 weeks

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

Timeframe: 28 Weeks

Trial details

NCT IDNCT07572331

SponsorNIRA Innovations Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-21

View on ClinicalTrials.gov More Skin Ageing trials