Herpes Simplex OralPhase 2NCT06558838
Efficacy and Safety of Acyclovir-penciclovir Cream Versus an Abreva in the Suppression of Herpes Simplex Virus Eruptions
A Phase 2 study testing acyclovir-penciclovir cream and Abreva in people with Herpes Simplex Oral, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Herpes Simplex Oral
- What is being tested?
- acyclovir-penciclovir cream and Abreva
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to 30 Nov 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah MidValley Dermatology
Murray, Utah, 84107
About this study
Official title: A Randomized, Parallel Group, Pilot Study to Assess Efficacy and Safety of Acyclovir-penciclovir Cream Versus an Active Comparator (Abreva) in the Suppression of Herpes Simplex Virus Eruptions in Subjects With a History of Herpes Labialis
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.
Read the 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 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
- Herpes Simplex Oral
- Being tested
- acyclovir-penciclovir cream, Abreva
- Medical subject headings
- Stomatitis, Herpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acyclovir-penciclovir creamDrug
Patients will treat their cold sore with active study drug based upon their randomization
AbrevaDrug
Also called Docosanol
Patients will treat their cold sore with Abreva based upon their randomization
| Study group | Role | What they receive |
|---|---|---|
| Study Drug (acyclovir-penciclovir cream) | Experimental | Patients will treat herpes simplex eruption with active study drug. Receives: Drug: acyclovir-penciclovir cream |
| Active Comparator (Abreva) | Active comparator | Patients will treat herpes simplex eruption with Abreva. Receives: Drug: Abreva |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Number of participants who did not progress to Stage 3 (vesicle) of a UV-induced herpes labialis outbreak following UV radiation exposure.
Measured: up to 25 days per participant
Secondary outcomes (1)
Time to Healing, Defined as Loss of Hard Crust
Number of days from lesion onset to healing, defined as loss of hard crust, in participants treated with acyclovir-penciclovir cream compared with participants treated with docosanol 10% cream (Abreva).
Measured: up to 25 days per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start19 Aug 2024
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Herpes Simplex OralStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a randomized, efficacy assessor-blinded, parallel group, pilot study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Hull, University of Utah
- Investigators
- Christopher M Hull, M.D., Principal investigator, University of Utah Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558838
- Sponsor's protocol ID
- IRB_00143253
- Status last verified
- Oct 2026
- First submitted
- 14 Aug 2024
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24942591Evans 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.
PubMed 12019102Hunsperger 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.
PubMed 12692270Jensen 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.
PubMed 14966254Raborn GW, Grace MG. Recurrent herpes simplex labialis: selected therapeutic options. J Can Dent Assoc. 2003 Sep;69(8):498-503.
PubMed 12954137Spruance SL. The natural history of recurrent oral-facial herpes simplex virus infection. Semin Dermatol. 1992 Sep;11(3):200-6.
PubMed 1390034Spruance 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.
PubMed 9878012Spruance 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.
PubMed 10837169
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel Group, Pilot Study to Assess Efficacy and Safety of Acyclovir-penciclovir Cream Versus an Active Comparator (Abreva) in the Suppression of Herpes Simplex Virus Eruptions in Subjects With a History of Herpes Labialis
- ClinicalTrials.gov ID
- NCT06558838
- Acronym / sponsor ID
- IRB_00143253
- Conditions
- Herpes Simplex Oral
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Posted 27 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a randomized, efficacy assessor-blinded, parallel group, pilot study.
| Arm | Type | Receives |
|---|---|---|
| Study Drug (acyclovir-penciclovir cream) | Experimental | Drug: acyclovir-penciclovir creamPatients will treat herpes simplex eruption with active study drug. |
| Active Comparator (Abreva) | Active comparator | Drug: AbrevaPatients will treat herpes simplex eruption with Abreva. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acyclovir-penciclovir creamPatients will treat their cold sore with active study drug based upon their randomization | Drug | Study Drug (acyclovir-penciclovir cream) |
| AbrevaAlso: DocosanolPatients will treat their cold sore with Abreva based upon their randomization | Drug | Active Comparator (Abreva) |
Primary outcome
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
Time frame: up to 25 days per participant
Number of participants who did not progress to Stage 3 (vesicle) of a UV-induced herpes labialis outbreak following UV radiation exposure.
1 secondary outcome
Time to Healing, Defined as Loss of Hard Crust
Time frame: up to 25 days per participant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24942591Cheshenko 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.
- Background: PubMed 12019102Evans 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.
- Background: PubMed 12692270Hunsperger 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.
- Background: PubMed 14966254Jensen 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.
- Background: PubMed 12954137Raborn GW, Grace MG. Recurrent herpes simplex labialis: selected therapeutic options. J Can Dent Assoc. 2003 Sep;69(8):498-503.
- Background: PubMed 1390034Spruance SL. The natural history of recurrent oral-facial herpes simplex virus infection. Semin Dermatol. 1992 Sep;11(3):200-6.
- Background: PubMed 9878012Spruance 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.
- Background: PubMed 10837169Spruance 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher M Hull, M.D. principal investigator
University of Utah Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acyclovir-penciclovir cream and Abreva in people with Herpes Simplex Oral, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: up to 25 days per participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06558838, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.