Skin AgeingNCT07572331
Clinical Study Evaluating the Safety and Effectiveness of the NIRA Laser M2.1 for the Treatment of Full-Face Wrinkles
A study testing NIRA Laser M2.1 and Topical in people with Skin Ageing and Facial Wrinkles, run by NIRA Innovations Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Skin Ageing, Facial Wrinkles, Acne
- What is being tested?
- NIRA Laser M2.1 and Topical
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2025to 21 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northeast Dermatology Associates
Beverly, Massachusetts, 01915
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Skin Ageing, Facial Wrinkles, Acne, Skin Elasticity, Infraorbital Dark Circle Severity, Skin Firmness
- Being tested
- NIRA Laser M2.1, Topical
- Keywords
- NIRA, Facial Wrinkles, Wrinkles, Full-Face Wrinkles, 1450 nm, 1450 nm laser, Fitzpatrick Wrinkle Scale, Acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRA Laser M2.1Device
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.
TopicalOther
Topical skincare formulation designed for twice daily, full-face application. Used in Arm 2 only in addition to the NIRA Laser M2.1.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: NIRA Laser M2.1; Other: Topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 28 Weeks
Secondary outcomes (4)
ARM 1 and ARM 2: Full-Face Wrinkle Subject Satisfaction Secondary Endpoint
The secondary endpoint will be participant satisfaction, as determined by a post-treatment questionnaire.
Measured: 16 weeks
ARM 1 and ARM 2: Change From Baseline in Infraorbital Dark Circle Severity
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.
Measured: 28 weeks
ARM 1 and ARM 2: Change From Baseline in Skin Elasticity
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.
Measured: 28 Weeks
ARM 1 and ARM 2: Change From Baseline in Skin Firmness
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.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start13 Jan 2025
- Primary completion21 Oct 2025
- Study completion21 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- NIRA Innovations Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572331
- Sponsor's protocol ID
- DP-1003
- Other IDs
- 20244922
- Status last verified
- Mar 2026
- First submitted
- 24 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIRA™ Laser M2.1 and Topical Treatment of Full-Face Wrinkles: A CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT07572331
- Acronym / sponsor ID
- DP-1003
- Conditions
- Skin Ageing, Facial Wrinkles, Acne, Skin Elasticity, Infraorbital Dark Circle Severity, Skin Firmness
- Keywords
- NIRA, Facial Wrinkles, Wrinkles, Full-Face Wrinkles, 1450 nm, 1450 nm laser, Fitzpatrick Wrinkle Scale, Acne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- NIRA Innovations Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIRA Laser M2.1 | Experimental | Device: NIRA Laser M2.1Arm 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). |
| NIRA Laser M2.1 Followed by Topical Treatment | Other | Device: NIRA Laser M2.1, Other: TopicalArm 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRA Laser M2.1Hand-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. | Device | NIRA Laser M2.1, NIRA Laser M2.1 Followed by Topical Treatment |
| TopicalTopical skincare formulation designed for twice daily, full-face application. Used in Arm 2 only in addition to the NIRA Laser M2.1. | Other | NIRA Laser M2.1 Followed by Topical Treatment |
Primary outcome
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.
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.
4 secondary outcomes
ARM 1 and ARM 2: Full-Face Wrinkle Subject Satisfaction Secondary Endpoint
Time frame: 16 weeks
ARM 1 and ARM 2: Change From Baseline in Infraorbital Dark Circle Severity
Time frame: 28 weeks
ARM 1 and ARM 2: Change From Baseline in Skin Elasticity
Time frame: 28 Weeks
ARM 1 and ARM 2: Change From Baseline in Skin Firmness
Time frame: 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRA Laser M2.1 and Topical in people with Skin Ageing and Facial Wrinkles, run by NIRA Innovations Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ARM 1 and ARM 2: Full Face Wrinkle Effectiveness Primary Endpoint a) (time frame: 28 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.