Nail DiseasesPhase 4NCT07820969
Post-op Analgesia of Nail Unit Procedures
A Phase 4 study testing Suzetrigine, Oxycodone/Acetaminophen and Acetaminophen in people with Nail Diseases, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to directly compare the efficacy of suzetrigine vs. oxycodone+acetaminophen vs. alternating acetaminophen/ibuprofen in controlling post-operative pain after the following nail unit procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nail Diseases
- What is being tested?
- Suzetrigine, Oxycodone/Acetaminophen and Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients age 18+ able to understand and provide written consent in English or Spanish who present to Dr. Brian Morrison's clinic at the University of Miami and are undergoing a nail unit procedure.
Who cannot join
- Patients under the age of 18 or adults unable to consent.
- Patients who are pregnant or incarcerated.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Miami, Phillip Frost Dermatology Clinic
Miami, Florida, 33136
Brian W Morrison, MD, 305-243-4472, bmorrison@med.miami.edu
Brian Morrison, MD
About this study
Official title: Post-operative Analgesia of Nail Unit Procedures: A Prospective Pilot Study Comparing Suzetrigine vs. Oxycodone+Acetaminophen vs. Acetaminophen/Ibuprofen
The purpose of this study is to directly compare the efficacy of suzetrigine vs. oxycodone+acetaminophen vs. alternating acetaminophen/ibuprofen in controlling post-operative pain after the following nail unit procedures.
- Conditions
- Nail Diseases
- Being tested
- Suzetrigine, Oxycodone/Acetaminophen, Acetaminophen, Ibuprofen
- Medical subject headings
- Nail Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuzetrigineDrug
Participants will receive two 50 mg oral tablets on day 1, followed by 50 mg oral tablets every 12 hours for 5 days
Oxycodone/AcetaminophenDrug
Also called Percocet®
Participants will receive oral oxycodone 5 mg/acetaminophen 325 mg (Percocet®) as a fixed-dose combination tablet every 6 hours for 5 days, beginning on the day of the nail procedure.
AcetaminophenDrug
Participants will receive acetaminophen 650 mg orally every 6 hours, alternating with ibuprofen, for 5 days beginning on the day of the nail procedure.
IbuprofenDrug
Participants will receive ibuprofen 400 mg orally every 6 hours, alternating with acetaminophen, for 5 days beginning on the day of the nail procedure.
| Study group | Role | What they receive |
|---|---|---|
| Suzetrigine Group | Experimental | Participants in this arm will receive suzetrigine for 5 days for post-operative pain management following nail unit procedures. Receives: Drug: Suzetrigine |
| Oxycodone + Acetaminophen Combination Group | Active comparator | Participants in this arm will receive a combination of oxycodone and acetaminophen for 5 days for post-operative pain management following nail unit procedures. Receives: Drug: Oxycodone/Acetaminophen |
| Alternating Acetaminophen/Ibuprofen Group | Active comparator | Participants in this arm will receive alternating acetaminophen and ibuprofen administered orally every 6 hours for 5 days starting the day of the nail procedure. Receives: Drug: Acetaminophen; Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post-Operative Pain Intensity
Pot-operative pain intensity measured using the Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst possible pain; higher scores indicate greater pain following nail unit procedures.
Measured: 24 hours post nail procedure, 48 hours post nail procedure, 72 hours post nail procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nail DiseasesStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian W Morrison, University of Miami
- Investigators
- Brian Morrison, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820969
- Sponsor's protocol ID
- 20260661
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Analgesia of Nail Unit Procedures: A Prospective Pilot Study Comparing Suzetrigine vs. Oxycodone+Acetaminophen vs. Acetaminophen/Ibuprofen
- ClinicalTrials.gov ID
- NCT07820969
- Acronym / sponsor ID
- 20260661
- Conditions
- Nail Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 15 Sep 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.
The purpose of this study is to directly compare the efficacy of suzetrigine vs. oxycodone+acetaminophen vs. alternating acetaminophen/ibuprofen in controlling post-operative pain after the following nail unit procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suzetrigine Group | Experimental | Drug: SuzetrigineParticipants in this arm will receive suzetrigine for 5 days for post-operative pain management following nail unit procedures. |
| Oxycodone + Acetaminophen Combination Group | Active comparator | Drug: Oxycodone/AcetaminophenParticipants in this arm will receive a combination of oxycodone and acetaminophen for 5 days for post-operative pain management following nail unit procedures. |
| Alternating Acetaminophen/Ibuprofen Group | Active comparator | Drug: Acetaminophen, Drug: IbuprofenParticipants in this arm will receive alternating acetaminophen and ibuprofen administered orally every 6 hours for 5 days starting the day of the nail procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients age 18+ able to understand and provide written consent in English or Spanish who present to Dr. Brian Morrison's clinic at the University of Miami and are undergoing a nail unit procedure.
Key exclusion criteria (2 listed)
- Patients under the age of 18 or adults unable to consent.
- Patients who are pregnant or incarcerated.
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 |
|---|---|---|
| SuzetrigineParticipants will receive two 50 mg oral tablets on day 1, followed by 50 mg oral tablets every 12 hours for 5 days | Drug | Suzetrigine Group |
| Oxycodone/AcetaminophenAlso: Percocet®Participants will receive oral oxycodone 5 mg/acetaminophen 325 mg (Percocet®) as a fixed-dose combination tablet every 6 hours for 5 days, beginning on the day of the nail procedure. | Drug | Oxycodone + Acetaminophen Combination Group |
| AcetaminophenParticipants will receive acetaminophen 650 mg orally every 6 hours, alternating with ibuprofen, for 5 days beginning on the day of the nail procedure. | Drug | Alternating Acetaminophen/Ibuprofen Group |
| IbuprofenParticipants will receive ibuprofen 400 mg orally every 6 hours, alternating with acetaminophen, for 5 days beginning on the day of the nail procedure. | Drug | Alternating Acetaminophen/Ibuprofen Group |
Primary outcome
Change in Post-Operative Pain Intensity
Time frame: 24 hours post nail procedure, 48 hours post nail procedure, 72 hours post nail procedure
Pot-operative pain intensity measured using the Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst possible pain; higher scores indicate greater pain following nail unit procedures.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Brian Morrison, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suzetrigine, Oxycodone/Acetaminophen and Acetaminophen in people with Nail Diseases, run by University of Miami 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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 1 Oct 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian W Morrison, MD (305-243-4472, bmorrison@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Post-Operative Pain Intensity (time frame: 24 hours post nail procedure, 48 hours post nail procedure, 72 hours post nail procedure). 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 1 Oct 2026.