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Efficacy and Safety of Acyclovir-penciclovir Cream Versus an Abreva in the Suppression of Herpes Simplex Virus Eruptions

Phase 2
Waitlist Available
Led By Christopher M Hull, M.D.
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 25 days per patient
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Cold Sores

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 25 days per patient
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 25 days per patient for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of subjects using acyclovir-penciclovir cream versus those using the Comparator, who do not progress to Stage 3 (vesicle) of a herpes labialis outbreak following UV radiation exposure
Secondary study objectives
Time of duration of the lesion until healed (loss of hard crust) of patients using acyclovir-penciclovir cream compared to those using the active comparator.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Study Drug (acyclovir-penciclovir cream)Experimental Treatment1 Intervention
Patients will treat herpes simplex eruption with active study drug.
Group II: Active Comparator (Abreva)Active Control1 Intervention
Patients will treat herpes simplex eruption with Abreva.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,146 Previous Clinical Trials
1,698,976 Total Patients Enrolled
Christopher M Hull, M.D.Principal InvestigatorUniversity of Utah Dermatology
1 Previous Clinical Trials
20 Total Patients Enrolled
~27 spots leftby Aug 2025