Suzetrigine vs Norco-PostOp Mohs Pain
Non-Opioid Pain Management After Mohs Reconstruction: An Investigator-Initiated, Prospective, Randomized Clinical Trial of Suzetrigine vs Hydrocodone/Acetaminophen
1 other identifier
interventional
75
1 country
1
Brief Summary
To compare suzetrigine versus hydrocodone/acetaminophen for postoperative pain control following dermatologic surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2025
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 3, 2025
CompletedFirst Submitted
Initial submission to the registry
May 4, 2026
CompletedFirst Posted
Study publicly available on registry
May 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
May 8, 2026
May 1, 2026
2.1 years
May 4, 2026
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
48hours post surgery
Secondary Outcomes (3)
Patient-reported adequacy of pain control
48hours post surgery
Rescue pain management use
48hours post surgery
Adverse Events
3 days after surgery
Study Arms (2)
Standard of Care
ACTIVE COMPARATORParticipants will receive the standard of care drug Norco (a medicine that combines hydrocodone and acetaminophen).
Control
ACTIVE COMPARATORParticipants will receive the control drug, Suzetrigine.
Interventions
Eligibility Criteria
You may qualify if:
- adults between the age of 18-89
- individuals who have a cutaneous tumor treated by MMS
You may not qualify if:
- individuals younger than 18 and older than 89
- individuals taking medications that interact with the CYP3A (Cytochrome P450 3A) pathway
- individuals with liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baylor University Medical Center
Dallas, Texas, 75246, United States
Related Publications (2)
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. Erratum in: J Am Acad Dermatol. 2015 Apr;72(4):748. PMID: 22959232.
BACKGROUNDPhillips, Shay, et al.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stan Tolkachjov, MD
Baylor Medical University Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2026
First Posted
May 8, 2026
Study Start
November 3, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
May 8, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share