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

NCT06558838 | Completed Phase 2 FDA Drug

• 1 other identifier: IRB_00143253
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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-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.

Conditions

Herpes Simplex Oral

Outcome Measures

Primary Outcomes (1)

• 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

  We will measure the number of subjects who do not progress to Stage 3 of herpes labialis outbreak

  up to 25 days per patient

Secondary Outcomes (1)

• 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.

  up to 25 days per patient

Study Arms (2)

Study Drug (acyclovir-penciclovir cream)

EXPERIMENTAL

Patients will treat herpes simplex eruption with active study drug.

Drug: acyclovir-penciclovir cream

Active Comparator (Abreva)

ACTIVE COMPARATOR

Patients will treat herpes simplex eruption with Abreva.

Drug: Abreva

Interventions

acyclovir-penciclovir cream DRUG

Patients will treat their cold sore with active study drug based upon their randomization

Study Drug (acyclovir-penciclovir cream)

Abreva DRUG

Patients will treat their cold sore with Abreva based upon their randomization

Also known as: Docosanol

Active Comparator (Abreva)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah MidValley Dermatology

Murray, Utah, 84107, United States

Location

Related Publications (8)

• Cheshenko N, Trepanier JB, Gonzalez PA, Eugenin EA, Jacobs WR Jr, Herold BC. Herpes simplex virus type 2 glycoprotein H interacts with integrin alphavbeta3 to facilitate viral entry and calcium signaling in human genital tract epithelial cells. J Virol. 2014 Sep 1;88(17):10026-38. doi: 10.1128/JVI.00725-14. Epub 2014 Jun 18.

  PMID: 24942591 BACKGROUND

• Evans TG, Bernstein DI, Raborn GW, Harmenberg J, Kowalski J, Spruance SL. Double-blind, randomized, placebo-controlled study of topical 5% acyclovir-1% hydrocortisone cream (ME-609) for treatment of UV radiation-induced herpes labialis. Antimicrob Agents Chemother. 2002 Jun;46(6):1870-4. doi: 10.1128/AAC.46.6.1870-1874.2002.

  PMID: 12019102 BACKGROUND

• Hunsperger EA, Wilcox CL. Capsaicin-induced reactivation of latent herpes simplex virus type 1 in sensory neurons in culture. J Gen Virol. 2003 May;84(Pt 5):1071-1078. doi: 10.1099/vir.0.18828-0.

  PMID: 12692270 BACKGROUND

• Jensen LA, Hoehns JD, Squires CL. Oral antivirals for the acute treatment of recurrent herpes labialis. Ann Pharmacother. 2004 Apr;38(4):705-9. doi: 10.1345/aph.1D285. Epub 2004 Feb 13.

  PMID: 14966254 BACKGROUND

• Raborn GW, Grace MG. Recurrent herpes simplex labialis: selected therapeutic options. J Can Dent Assoc. 2003 Sep;69(8):498-503.

  PMID: 12954137 BACKGROUND

• Spruance SL. The natural history of recurrent oral-facial herpes simplex virus infection. Semin Dermatol. 1992 Sep;11(3):200-6.

  PMID: 1390034 BACKGROUND

• Spruance SL, Rowe NH, Raborn GW, Thibodeau EA, D'Ambrosio JA, Bernstein DI. Peroral famciclovir in the treatment of experimental ultraviolet radiation-induced herpes simplex labialis: A double-blind, dose-ranging, placebo-controlled, multicenter trial. J Infect Dis. 1999 Feb;179(2):303-10. doi: 10.1086/314605.

  PMID: 9878012 BACKGROUND

• Spruance SL, McKeough MB. Combination treatment with famciclovir and a topical corticosteroid gel versus famciclovir alone for experimental ultraviolet radiation-induced herpes simplex labialis: a pilot study. J Infect Dis. 2000 Jun;181(6):1906-10. doi: 10.1086/315528. Epub 2000 May 31.

  PMID: 10837169 BACKGROUND

MeSH Terms

Conditions

Stomatitis, Herpetic

Interventions

docosanol

Condition Hierarchy (Ancestors)

Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Stomatitis; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Christopher M Hull, M.D.

  University of Utah Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Efficacy assessments will be done by a qualified trained blinded assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dermatology

Model Details: This will be a randomized, efficacy assessor-blinded, parallel group, pilot study.

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 19, 2024
• Study Start: August 19, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)