Status:
COMPLETED
Efficacy and Safety of Acyclovir-penciclovir Cream Versus an Abreva in the Suppression of Herpes Simplex Virus Eruptions
Lead Sponsor:
University of Utah
Conditions:
Herpes Simplex Oral
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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-penciclo...
Detailed Description
This will be a randomized, efficacy assessor-blinded, parallel group, pilot study of up to 40 subjects with documented herpes labialis. Potential subjects will be assessed during a screening visit th...
Eligibility Criteria
Inclusion
- Understands the requirements of the study and provides written informed consent prior to undergoing any study-related procedures.
- Subject is a male or female between the ages of 18-80 years old, inclusive.
- Fitzpatrick skin type II or III.
- History of at least one year of herpes labialis induced by UV exposure.
- Able to recall exact location of most common or most recent outbreak.
- History of at least 50% of cold sore outbreaks occurring with UV (sun) exposure.
- At least 1 HSV-1 outbreak within the past 12 months.
- Experiences prodromal symptoms before HSV-1 outbreaks.
- Subject is willing and able to comply with protocol-specified dosing, visits to the clinic and tracking of pain.
Exclusion
- Outbreak \<2 weeks prior to enrollment.
- History of herpes simplex vaccine.
- On antiviral suppression within the past 30 days.
- Requires more than acetaminophen for pain from recurrent HSV outbreaks.
- On any systemic or topical steroid, immune suppressant or chemotherapeutic agent within the past 14 days.
- Use of tanning beds, history of sunburn, or beach vacation \<2 weeks prior to enrollment.
- History of photosensitivity, lupus erythematosus, or current use of a highly photosensitizing medication in the opinion of the investigator.
- Current immunosuppressed state due to underlying disease (i.e. HIV infection) concomitant treatment (i.e. chemotherapy).
- Current upper respiratory tract infection or any active illness that could trigger cold sores or affect overall health of the patient or the assessment of the study agent.
- Pregnant or intending to become pregnant during the study.
- Abnormal skin conditions in the area of the recurrent HSV1 outbreaks.
- Enrolled in another clinical trial within the past 30 days.
- On any analgesics or NSAIDs that cannot be stopped during the study.
- Alcohol or drug abuse.
Key Trial Info
Start Date :
August 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06558838
Start Date
August 19 2024
End Date
November 30 2025
Last Update
January 5 2026
Active Locations (1)
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1
University of Utah MidValley Dermatology
Murray, Utah, United States, 84107