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NCT06558838 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Acyclovir-penciclovir Cream Versus an Abreva in the Suppression of Herpes Simplex Virus Eruptions
A Phase 2 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT06558838 is a Phase 2 study that has completed, run by University of Utah. The registered enrollment target is 40 participants.
The verdict
NCT06558838, a Phase 2 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This will be a randomized, efficacy assessor-blinded, parallel group, pilot study of up to 40 subjects with documented herpes labialis. Patients will be treated with the study drug, acyclovir-penciclovir cream, or the active comparator of Abreva. Potential subjects will be assessed during a screening visit that must take place no greater than 2 weeks prior to the Day 1 (Baseline) visit. During the screening period, subjects that meet all other entry criteria will undergo Ultraviolet susceptibility testing to determine the subject's individual minimal erythema dose (MED). Ultraviolet susceptibility testing takes place over two days with exposure to Ultraviolet light on specified regions on the subject's back followed by an assessment of the exposed areas 24 hours later to identify the MED. Subjects who have a measurable MED will be allowed to enroll in the study. Each subject will be randomly assigned in a 1:1 ratio to receive either acyclovir-penciclovir cream or Comparator (Abreva). Patients who express a cold sore will track the lesion with a diary card to rate their pain levels, and any unusual symptoms at Day 1, Day 3, Day 5, Day 7, and Day 10. Patients may also take photographs of the lesion throughout the study.
Interventions
- DRUG Abreva
- DRUG acyclovir-penciclovir cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-08-19 |
| Est. Completion | 2025-11-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06558838
The ClinicalTrials.gov registry entry for NCT06558838 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Abreva is the first listed.
NCT06558838 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06558838 about?
NCT06558838 is a clinical study titled "Efficacy and Safety of Acyclovir-penciclovir Cream Versus an Abreva in the Suppression of Herpes Simplex Virus Eruptions". This will be a randomized, efficacy assessor-blinded, parallel group, pilot study of up to 40 subjects with documented herpes labialis. Patients will be treated with the study drug, acyclovir-penciclovir cream, or the active comparator of Abreva. Potential subjects will be assessed during a screeni...
What is the current status of trial NCT06558838?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2024-08-19. Estimated completion is 2025-11-30.
What interventions are being tested in trial NCT06558838?
The interventions under investigation include: Abreva (DRUG), acyclovir-penciclovir cream (DRUG).
Who is sponsoring clinical trial NCT06558838?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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