Cutaneous TumorsPhase 4NCT07575230
Suzetrigine vs Norco-postoperative Mohs Pain
A Phase 4 study testing Norco 5Mg-325Mg Tablet and Suzetrigine in people with Cutaneous Tumors and Mohs Micrographic Surgery, run by Baylor Research Institute at 1 site in United States.
Trial summary
To compare suzetrigine versus hydrocodone/acetaminophen for postoperative pain control following dermatologic surgery. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Cutaneous Tumors, Mohs Micrographic Surgery
- What is being tested?
- Norco 5Mg-325Mg Tablet and Suzetrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2025to Dec 2027
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults between the age of 18-89
- individuals who have a cutaneous tumor treated by MMS
Who cannot join
- individuals younger than 18 and older than 89
- individuals taking medications that interact with the CYP3A (Cytochrome P450 3A) pathway
- individuals with liver disease
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
Baylor University Medical Center
Dallas, Texas, 75246
About this study
Official title: Non-Opioid Pain Management After Mohs Reconstruction: An Investigator-Initiated, Prospective, Randomized Clinical Trial of Suzetrigine vs Hydrocodone/Acetaminophen
To compare suzetrigine versus hydrocodone/acetaminophen for postoperative pain control following dermatologic surgery.
Read the detailed description
This study is a randomized, controlled trial that is evaluating the safety and efficacy of suzetrigine as a postoperative pain medication compared to the standard of care Hydrocodone/Acetaminophen in patients undergoing Mohs micrographic surgery (MMS) who are at high-risk for postoperative pain and opioid use. The goal is to reduce opioid prescription use and give patients a non-opioid pain medication option for particularly painful surgeries. Patients will be randomized into one of two groups, one group will receive the interventional medication and the other the standard of care medication.
- Conditions
- Cutaneous Tumors, Mohs Micrographic Surgery
- Being tested
- Norco 5Mg-325Mg Tablet, Suzetrigine
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norco 5Mg-325Mg TabletDrug
Standard of care drug
SuzetrigineDrug
Control Drug
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Participants will receive the standard of care drug Norco (a medicine that combines hydrocodone and acetaminophen). Receives: Drug: Norco 5Mg-325Mg Tablet |
| Control | Active comparator | Participants will receive the control drug, Suzetrigine. Receives: Drug: Suzetrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in need for opioid medication for pain management after Mohs micrographic surgery
Change in mean visual analog scale (VAS; 0-10) pain scores at 24 and 48 hours after surgery with a minimal change in pain score of 1.0 points.
Measured: 48hours post surgery
Secondary outcomes (3)
Patient-reported adequacy of pain control
Assessment of pain control with use of medication following surgery.
Measured: 48hours post surgery
Rescue pain management use
Changes in need to use rescue medication for pain management
Measured: 48hours post surgery
Adverse Events
Evaluation of occurence of adverse events (irregular heart beat, abnormal blood pressure, change in consciousness, or need for urgent care or emergency room visit in the first 3 days after surgery).
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start3 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cutaneous TumorsStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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
- Model description
- Participants are randomized into one of two group: interventional group and control group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stan Tolkachjov, MD, Principal investigator, Baylor Medical University Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575230
- Sponsor's protocol ID
- 025-413
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ad Hoc Task Force; Connolly SM, Baker DR, Coldiron BM, Fazio MJ, Storrs PA, Vidimos AT, Zalla MJ, Brewer JD, Smith Begolka W; Ratings Panel; Berger TG, Bigby M, Bolognia JL, Brodland DG, Collins S, Cronin TA Jr, Dahl MV, Grant-Kels JM, Hanke CW, Hruza GJ, James WD, Lober CW, McBurney EI, Norton SA, Roenigk RK, Wheeland RG, Wisco OJ. AAD/ACMS/ASDSA/ASMS 2012 appropriate use criteria for Mohs micrographic surgery: a report of the American Academy of Dermatology, American College of Mohs Surgery, American Society for Dermatologic Surgery Association, and the American Society for Mohs Surgery. J Am Acad Dermatol. 2012 Oct;67(4):531-50. doi: 10.1016/j.jaad.2012.06.009. Epub 2012 Sep 5.
PubMed 22959232Phillips, Shay, et al.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Opioid Pain Management After Mohs Reconstruction: An Investigator-Initiated, Prospective, Randomized Clinical Trial of Suzetrigine vs Hydrocodone/Acetaminophen
- ClinicalTrials.gov ID
- NCT07575230
- Acronym / sponsor ID
- 025-413
- Conditions
- Cutaneous Tumors, Mohs Micrographic Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 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.
To compare suzetrigine versus hydrocodone/acetaminophen for postoperative pain control following dermatologic surgery.
Detailed description
This study is a randomized, controlled trial that is evaluating the safety and efficacy of suzetrigine as a postoperative pain medication compared to the standard of care Hydrocodone/Acetaminophen in patients undergoing Mohs micrographic surgery (MMS) who are at high-risk for postoperative pain and opioid use. The goal is to reduce opioid prescription use and give patients a non-opioid pain medication option for particularly painful surgeries. Patients will be randomized into one of two groups, one group will receive the interventional medication and the other the standard of care medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized into one of two group: interventional group and control group
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: Norco 5Mg-325Mg TabletParticipants will receive the standard of care drug Norco (a medicine that combines hydrocodone and acetaminophen). |
| Control | Active comparator | Drug: SuzetrigineParticipants will receive the control drug, Suzetrigine. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults between the age of 18-89
- individuals who have a cutaneous tumor treated by MMS
Key exclusion criteria (3 listed)
- individuals younger than 18 and older than 89
- individuals taking medications that interact with the CYP3A (Cytochrome P450 3A) pathway
- individuals with liver disease
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 |
|---|---|---|
| Norco 5Mg-325Mg TabletStandard of care drug | Drug | Standard of Care |
| SuzetrigineControl Drug | Drug | Control |
Primary outcome
Change in need for opioid medication for pain management after Mohs micrographic surgery
Time frame: 48hours post surgery
Change in mean visual analog scale (VAS; 0-10) pain scores at 24 and 48 hours after surgery with a minimal change in pain score of 1.0 points.
3 secondary outcomes
Patient-reported adequacy of pain control
Time frame: 48hours post surgery
Rescue pain management use
Time frame: 48hours post surgery
Adverse Events
Time frame: 3 days after surgery
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 11 May 2026.
- Background: PubMed 22959232Ad Hoc Task Force; Connolly SM, Baker DR, Coldiron BM, Fazio MJ, Storrs PA, Vidimos AT, Zalla MJ, Brewer JD, Smith Begolka W; Ratings Panel; Berger TG, Bigby M, Bolognia JL, Brodland DG, Collins S, Cronin TA Jr, Dahl MV, Grant-Kels JM, Hanke CW, Hruza GJ, James WD, Lober CW, McBurney EI, Norton SA, Roenigk RK, Wheeland RG, Wisco OJ. AAD/ACMS/ASDSA/ASMS 2012 appropriate use criteria for Mohs micrographic surgery: a report of the American Academy of Dermatology, American College of Mohs Surgery, American Society for Dermatologic Surgery Association, and the American Society for Mohs Surgery. J Am Acad Dermatol. 2012 Oct;67(4):531-50. doi: 10.1016/j.jaad.2012.06.009. Epub 2012 Sep 5.
- BackgroundPhillips, Shay, et al.
- 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.
Stan Tolkachjov, MD principal investigator
Baylor Medical University Center
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 Norco 5Mg-325Mg Tablet and Suzetrigine in people with Cutaneous Tumors and Mohs Micrographic Surgery, run by Baylor Research Institute 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 2 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 11 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.
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?
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?
Change in need for opioid medication for pain management after Mohs micrographic surgery (time frame: 48hours post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07575230, which also lists 2 linked publications.
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 11 May 2026.