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NCT03997851 · ClinicalTrials.gov registry record · Phase 1
Topical Acetaminophen for Itch Relief: a Proof of Concept Study in Healthy Subjects
A Phase 1 study, sponsored by University of Miami.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT03997851: Completed Phase 1 study, sponsored by University of Miami.
NCT03997851 is a Phase 1 study that has completed, run by University of Miami. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03997851, a Phase 1 study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
Currently, topical antihistamines and corticosteroids are mainly used for itching relief. However, the over the counter antihistamines are not effective on all itch conditions. Acetaminophen is a popular and widely used OTC drug for pain relief. Although its mode of action is still unknown, recent studies have shown that acetaminophen indirectly activates cannabinoid CB1 receptors. Recent studies have shown that topical cannabinoid agonists are effective for itch relief, the efficacy of topical acetaminophen will be tested for non-histaminergic itch relief.
Primary Outcome
Peak itch intensity between the vehicle and 3 other active treatments (5%, 2.5%, and 1% acetaminophen gels) after non-histaminergic itch induction (cowhage). Itch intensity was measured on a 10cm scale visual analog scale for 10 minutes. 0 was weighted with "no itch" and 10 was weighted with "most itch imaginable".
Interventions
- DRUG Acetaminophen
- DRUG Carbomer 980
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-07-22 |
| Est. Completion | 2020-03-18 |
| Phase | Phase 1 |
What the finished NCT03997851 record still lists
NCT03997851 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Acetaminophen is the first listed.
NCT03997851 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03997851 about?
NCT03997851 is a clinical study titled "Topical Acetaminophen for Itch Relief: a Proof of Concept Study in Healthy Subjects". Currently, topical antihistamines and corticosteroids are mainly used for itching relief. However, the over the counter antihistamines are not effective on all itch conditions. Acetaminophen is a popular and widely used OTC drug for pain relief. Although its mode of action is still unknown, recent s...
What is the current status of trial NCT03997851?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2019-07-22. Estimated completion is 2020-03-18.
What interventions are being tested in trial NCT03997851?
The interventions under investigation include: Acetaminophen (DRUG), Carbomer 980 (DRUG).
Who is sponsoring clinical trial NCT03997851?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03997851's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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