Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558838
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Efficacy and Safety of Acyclovir-penciclovir Cream Versus an Abreva in the Suppression of Herpes Simplex Virus Eruptions
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 subjects individual minimal erythema dose MED Ultraviolet susceptibility testing takes place over two days with exposure to Ultraviolet light on specified regions on the subjects 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 11 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 subjects individual minimal erythema dose MED Ultraviolet susceptibility testing takes place over two days with exposure to Ultraviolet light on specified regions on the subjects 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 11 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 subjects 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 11 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 Patients diary card will be reviewed and if the patient have experienced a prodrome andor 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 andor 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 andor 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 lesions 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 andor 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 subjects 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 11 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 Patients diary card will be reviewed and if the patient have experienced a prodrome andor 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 andor 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 andor 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 lesions 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 andor lesion
A Safety follow-up phone call will occur 2 days after the EOS to determine if any new adverse events have occurred
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None