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

30 aprile 2026 aggiornato da: NIRA Innovations Inc.

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Massachusetts
      • Beverly, Massachusetts, Stati Uniti, 01915
        • Northeast Dermatology Associates

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
Dispositivo: 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.
Altro: 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.
Dispositivo: 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.
Altro: Topical
Topical skincare formulation designed for twice daily, full-face application. Used in Arm 2 only in addition to the NIRA Laser M2.1.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
ARM 1 and ARM 2: Full Face Wrinkle Effectiveness Primary Endpoint a)
Lasso di tempo: 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.
28 weeks
ARM 1 and ARM 2: Full Face Wrinkle Safety Primary Endpoint b)
Lasso di tempo: 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.
28 Weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
ARM 1 and ARM 2: Full-Face Wrinkle Subject Satisfaction Secondary Endpoint
Lasso di tempo: 16 weeks
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
Lasso di tempo: 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.
28 weeks
ARM 1 and ARM 2: Change From Baseline in Skin Elasticity
Lasso di tempo: 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.
28 Weeks
ARM 1 and ARM 2: Change From Baseline in Skin Firmness
Lasso di tempo: 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.
28 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

NIRA Innovations Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

13 gennaio 2025

Completamento primario (Effettivo)

21 ottobre 2025

Completamento dello studio (Effettivo)

21 ottobre 2025

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 aprile 2026

Primo Inserito (Effettivo)

7 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 aprile 2026

Ultimo verificato

1 marzo 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • DP-1003
  • 20244922 (Altro identificatore: WCG IRB)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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