Post-op Analgesia of Nail Unit Procedures

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07820969
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Nail Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Suzetrigine — DRUG
    Participants will receive two 50 mg oral tablets on day 1, followed by 50 mg oral tablets every 12 hours for 5 days
  • Oxycodone + Acetaminophen — DRUG
    Participants will receive Oxycodone + acetaminophen combination administered orally at a dose of 50 mg/325 mg per tablet, every 6 hours for 5 days starting the day of the nail procedure
  • Acetaminophen/Ibuprofen — DRUG
    Participants will receive Acetaminophen administered orally at a dose of 650 mg every 6 hours for 5 days starting the day of the nail procedure. Alternate with ibuprofen 400 mg every 6 hours for 5 days starting day of nail procedure

Study Details

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.

Key Dates

First listed
Sep 15, 2026
Start date
Oct 1, 2026
Status verified
Sep 2026
Primary completion
Oct 1, 2028
Completion
Oct 1, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Suzetrigine Group
    Participants in this arm will receive suzetrigine for 5 days for post-operative pain management following nail unit procedures.
  • Active Comparator: Oxycodone + Acetaminophen Combination Group
    Participants in this arm will receive a combination of oxycodone and acetaminophen for 5 days for post-operative pain management following nail unit procedures.
  • Active Comparator: Alternating Acetaminophen/ibuprofen Group
    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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami, Phillip Frost Dermatology ClinicMiamiFlorida33136
Brian W Morrison, MD
[email protected]
305-243-4472
Brian Morrison, MD (PRINCIPAL_INVESTIGATOR)

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University of Miami, Phillip Frost Dermatology Clinic· Miami, FL