Efficacy and Safety of Acyclovir-penciclovir Cream Versus an Abreva in the Suppression of Herpes Simplex Virus Eruptions
NCT ID: NCT06558838
Last Updated: 2026-01-05
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-08-19
Study Completion Date
2025-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
EDTA Eye Drops Compared to Abreva for Herpes Simplex Virus Eruptions
NCT04893577
Herpes Simplex Oral
COMPLETED
PHASE2
Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis
NCT02265913
Herpes Labialis
COMPLETED
PHASE3
Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis
NCT00361881
Herpes Labialis
COMPLETED
PHASE3
Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis
NCT01257074
Herpes Labialis
COMPLETED
PHASE3
Efficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis
NCT00736437
Herpes Labialis
COMPLETED
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 that must take place no greater than 2 weeks prior to the lesion induction visit. During the screening period, subjects that meet all other entry criteria will undergo ultraviolet (UV) susceptibility testing to determine their individual minimal erythemal dose (MED). UV susceptibility testing takes place over two days with exposure to UV 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 continue to the induction visit. Patients that do not have measurable MED response will be considered screen failures or patients may have repeat MED testing with different levels.
At the Induction Visit, subjects will undergo UV radiation at a level 3 times their MED. The exposed area of the lip will be marked with indelible ink and a baseline photo may be taken. Each subject will then be randomly assigned in a 1:1 ratio to receive either acyclovir-penciclovir cream or Comparator. Subjects will be dispensed study medication and instructed how to apply it to the exposed area. When the patient first senses the start of developing a cold sore and applies study medication will be considered Day 1. Dosing of the study product will be done five times daily, beginning at the time that a subject first senses the start of the prodromal phase (Day 1). Subjects will be given a diary card to record their pain levels, progression of lesion development and any unusual symptoms (not normally seen with their outbreaks).
Patients will be called daily by the study team after their induction visit to determine the start of prodrome. If after 7 days, the patient does not develop any prodromal senses, the patient will be considered an induction failure.
When the patient first senses signs or symptoms of a cold sore, the patient will have the Day 1 visit conducted within 24 hours. Day 1 visit may be conducted in person or as a MyChart Virtual Visit. Patient's diary card will be reviewed and if the patient have experienced a prodrome and/or lesion since the induction visit, their compliance with dosing will be checked. If the subject has noted any unusual symptoms, these will be discussed with medical personnel to determine if the symptoms represent a treatment emergent adverse event (AE). A photo will be taken of the irradiated area (as marked at the induction visit). The blinded assessor will assess the prodrome and/or lesion and take measurements.
On Days 3, 5, and 7, the subject will return to the clinic or follow up via virtual video call for assessment of the irradiated area. Study staff will review the subject diary to determine if the subject is correctly noting the lesion stage. Subjects will have a photo taken of the radiated area and asked to continue with dosing as instructed. Any diary card notation of unusual symptoms in subjects will be reviewed by study staff to determine if the symptoms represent a treatment emergent adverse event. The blinded assessor will assess the prodrome and/or lesion and take measurements. More study product may be dispensed as needed. Most subjects' lesions will have resolved by day 7, and those subjects will end study treatment after 7 full days of treatment. If lesion has not resolved by day 7, the maximum number of days the patient may use study drug treatment is 10 days.
The End of Study (EOS) is the final study visit that will take place on Day 10. A photo will be taken of the irradiated area, the diary card will be carefully reviewed and study product (including empty containers) will be collected. If subjects reach EOS without full resolution of their lesion(s), those subjects will discuss treatment options with the study doctor for remainder of the outbreak.
Measurements will be taken. If an adverse event has occurred but has not resolved by the EOS visit, the subject will be contacted once weekly and status noted until such time as the event has resolved. The blinded assessor will assess the prodrome and/or lesion.
A Safety follow-up phone call will occur 2 days after the EOS to determine if any new adverse events have occurred.
Potential subjects will be assessed during a screening visit that must take place no greater than 2 weeks prior to the lesion induction visit. During the screening period, subjects that meet all other entry criteria will undergo ultraviolet (UV) susceptibility testing to determine their individual minimal erythemal dose (MED). UV susceptibility testing takes place over two days with exposure to UV 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 continue to the induction visit. Patients that do not have measurable MED response will be considered screen failures or patients may have repeat MED testing with different levels.
At the Induction Visit, subjects will undergo UV radiation at a level 3 times their MED. The exposed area of the lip will be marked with indelible ink and a baseline photo may be taken. Each subject will then be randomly assigned in a 1:1 ratio to receive either acyclovir-penciclovir cream or Comparator. Subjects will be dispensed study medication and instructed how to apply it to the exposed area. When the patient first senses the start of developing a cold sore and applies study medication will be considered Day 1. Dosing of the study product will be done five times daily, beginning at the time that a subject first senses the start of the prodromal phase (Day 1). Subjects will be given a diary card to record their pain levels, progression of lesion development and any unusual symptoms (not normally seen with their outbreaks).
Patients will be called daily by the study team after their induction visit to determine the start of prodrome. If after 7 days, the patient does not develop any prodromal senses, the patient will be considered an induction failure.
When the patient first senses signs or symptoms of a cold sore, the patient will have the Day 1 visit conducted within 24 hours. Day 1 visit may be conducted in person or as a MyChart Virtual Visit. Patient's diary card will be reviewed and if the patient have experienced a prodrome and/or lesion since the induction visit, their compliance with dosing will be checked. If the subject has noted any unusual symptoms, these will be discussed with medical personnel to determine if the symptoms represent a treatment emergent adverse event (AE). A photo will be taken of the irradiated area (as marked at the induction visit). The blinded assessor will assess the prodrome and/or lesion and take measurements.
On Days 3, 5, and 7, the subject will return to the clinic or follow up via virtual video call for assessment of the irradiated area. Study staff will review the subject diary to determine if the subject is correctly noting the lesion stage. Subjects will have a photo taken of the radiated area and asked to continue with dosing as instructed. Any diary card notation of unusual symptoms in subjects will be reviewed by study staff to determine if the symptoms represent a treatment emergent adverse event. The blinded assessor will assess the prodrome and/or lesion and take measurements. More study product may be dispensed as needed. Most subjects' lesions will have resolved by day 7, and those subjects will end study treatment after 7 full days of treatment. If lesion has not resolved by day 7, the maximum number of days the patient may use study drug treatment is 10 days.
The End of Study (EOS) is the final study visit that will take place on Day 10. A photo will be taken of the irradiated area, the diary card will be carefully reviewed and study product (including empty containers) will be collected. If subjects reach EOS without full resolution of their lesion(s), those subjects will discuss treatment options with the study doctor for remainder of the outbreak.
Measurements will be taken. If an adverse event has occurred but has not resolved by the EOS visit, the subject will be contacted once weekly and status noted until such time as the event has resolved. The blinded assessor will assess the prodrome and/or lesion.
A Safety follow-up phone call will occur 2 days after the EOS to determine if any new adverse events have occurred.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Herpes Simplex Oral
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
This will be a randomized, efficacy assessor-blinded, parallel group, pilot study.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Efficacy assessments will be done by a qualified trained blinded assessor.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study Drug (acyclovir-penciclovir cream)
Patients will treat herpes simplex eruption with active study drug.
Group Type
EXPERIMENTAL
acyclovir-penciclovir cream
Intervention Type
DRUG
Patients will treat their cold sore with active study drug based upon their randomization
Active Comparator (Abreva)
Patients will treat herpes simplex eruption with Abreva.
Group Type
ACTIVE_COMPARATOR
Abreva
Intervention Type
DRUG
Patients will treat their cold sore with Abreva based upon their randomization
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
acyclovir-penciclovir cream
Patients will treat their cold sore with active study drug based upon their randomization
Intervention Type
DRUG
Abreva
Patients will treat their cold sore with Abreva based upon their randomization
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Docosanol
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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 Criteria
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Utah
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Christopher Hull
Professor, Dermatology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christopher M Hull, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Utah Dermatology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Utah MidValley Dermatology
Murray, Utah, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Raborn GW, Grace MG. Recurrent herpes simplex labialis: selected therapeutic options. J Can Dent Assoc. 2003 Sep;69(8):498-503.
Reference Type
BACKGROUND
Spruance SL. The natural history of recurrent oral-facial herpes simplex virus infection. Semin Dermatol. 1992 Sep;11(3):200-6.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB_00143253
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes
NCT02871492
COMPLETED
PHASE2
Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis in Immunocompromised Patients
NCT00735761
COMPLETED
PHASE3
A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients
NCT00002084
COMPLETED
NA
Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
NCT00362297
COMPLETED
PHASE4
Study to Compare Efficacy of Topical ARYS-01 (Sorivudine) Cream 3%, Oral Valaciclovir and Combination ARYS-01 Cream 3%/Oral Valaciclovir for Treatment of Herpes Zoster (Shingles)
NCT00652184
UNKNOWN
PHASE2
Safety, Tolerability and Therapeutic Efficacy of Topical ZEP-3 Ointment (1.0%) for the Treatment of Cold Sores
NCT02483182
COMPLETED
PHASE2
Hand Sanitizer Use for Herpes Simplex Virus-1
NCT06135844
RECRUITING
EARLY_PHASE1
Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons
NCT01026454
COMPLETED
PHASE4
A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients
NCT00002000
COMPLETED
NA
Effectiveness of Acyclovir in Suppressing HIV Viral Load in Women Coinfected With HIV and Herpes Simplex Virus Type 2 (HSV-2)
NCT00371592
COMPLETED
PHASE2
The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
NCT00001115
COMPLETED
NA
A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally
NCT05098938
COMPLETED
PHASE3
Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients
NCT00000953
COMPLETED
PHASE2
Phase 3 Clinical Study for the Treatment of Cold Sore
NCT00769314
COMPLETED
PHASE3
A Study to Assess the Safety, Pharmacokinetics, and Tolerability of ABI-1179 in Healthy Subjects and in Subjects Seropositive for HSV-2 With Recurrent Genital Herpes
NCT06698575
ACTIVE_NOT_RECRUITING
PHASE1
A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes
NCT00076232
COMPLETED
PHASE3
An Open-label Trial of the Effect of Valacyclovir on Plasma HIV-1 Levels Among HIV-1 Seropositive and HSV-1/2 Seronegative Persons
NCT01059084
WITHDRAWN
NA
A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
NCT00820534
COMPLETED
PHASE4
Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
NCT00006132
UNKNOWN
PHASE3
A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation
NCT00723229
COMPLETED
PHASE4
Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
NCT01658826
TERMINATED
PHASE2
Usage of Acyclovir for Suppression of HIV-1 and HSV-2 Coinfected Persons in Cameroon
NCT00209313
COMPLETED
PHASE2/PHASE3
A Comparison of 882C87 Versus Acyclovir in the Treatment of Herpes Zoster in Patients With Weakened Immune Systems
NCT00002315
COMPLETED
PHASE3