Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04893577
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-11-30
First Post:
2021-05-14
Brief Title:
EDTA Eye Drops Compared to Abreva for Herpes Simplex Virus Eruptions
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
A Randomized Efficacy Assessor-Blinded Study to Assess Preliminary Efficacy and Safety of EDTA Eye Drops v an Active Comparator in the Suppression of Herpes Simplex Virus Eruptions in Subjects With a History of Herpes Labialis
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 20 subjects with documented herpes labialis Patients will be treated with the study drug EDTA Eye Drops 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 UV susceptibility testing to determine their individual MED minimal erythemal dose 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 enroll in the study Each subject will be randomly assigned in a 11 ratio to receive either EED or Comparator
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 UV susceptibility testing to determine their individual MED minimal erythemal dose 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 enroll in the study Each subject will be randomly assigned in a 11 ratio to receive either EED or Comparator
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:
11 Background and Rationale Herpes simplex virus HSV infections are common and can cause significant morbidity both at the time of the original infection and when recurrences occur There are two types of HSV - HSV-1 and HSV-2 HSV-1 the most common cause of oral cold sores is transmitted mainly by oral-to-oral contact Genital herpes is usually caused by HSV-2 although HSV-1 can also cause genital breakouts Both HSV-1 and HSV-2 infections are lifelong with the virus living in the ganglia of nerves that supply the area of the original infection and recurring sporadically in the same area of that nerves innervation Most infections and recurrences are asymptomatic but infectious viral shedding can occur Patients who are not asymptomatic can develop prodromes of tingling pain or paresthesia and eventually blisters and ulcerations with pain Healing generally occurs within 10 to 19 days after onset in primary infection or within 5 to 10 days in recurrent infection Lesions usually heal completely but recurrent lesions at the same site may cause atrophy and scarring
According to WHO in 2012 an estimated 37 billion people under age 50 67 had HSV-1 infection globally Some patients have predictable outbreaks after exposure to noxious stimuli such as sunlight fever menstruation or stress
Researchers have found that calcium signaling is involved in the translocation of the virus from the ganglia to the eruption site It has been found that an increase of calcium levels in the extracellular matrix will precipitate the calcium signaling events that are causal to the migration of the HSV virus from the proximal ganglia to the eruption site Hunsperger 2003 Cheshenko 2003 Further Husperger found in her experiments in vitro that the chelation of calcium greatly reduced the reactivation of the HSV virus
EDTA Eye Drops EED which consists of a calcium chelator and a permeation enhancer could be one such intervention Livionex has had some anecdotal evidence that this intervention could work at preventing an HSV eruption and post prodromal viral shedding
IRB-approved clinical studies of HSV-1 have been performed in normal human volunteers with a history of HSV-1 who develop recurrences with prodromes after exposure to UV light We will use this technique to induce recurrences in susceptible HSV-1 infected individuals then treat with EED or Comparator 5 times daily
Abreva has been chosen as the Comparator product in this study because it is approved by the FDA for treatment of HSV-related cold sores Dosing 5 timesday has been selected as the dosing regimen because that is the dosing regimen approved for Abreva by FDA The manufacturers of Abreva recommend that subjects not be treated for greater than 10 days A maximum of 7 days treatment with study product has been chosen for this study
Thus treatment in both groups of subjects will be 5 times daily and will last until healing of the lesion or up to 7 days following the onset of the prodrome
2 OBJECTIVE To collect preliminary efficacy and safety data on the use of EED in subjects with a history of herpes labialis following UV Radiation
This will be a randomized efficacy assessor-blinded parallel group pilot study of up to 20 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 Baseline visit During the screening period subjects that meet all other entry criteria will undergo UV susceptibility testing to determine their individual MED minimal erythemal dose 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 enroll in the study Each subject will be randomly assigned in a 11 ratio to receive either EED or Comparator
On Day 1 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 photograph may be taken Specifics on the process for UV exposure will be explained in the study manual Subjects will be dispensed study medication and instructed how to apply it to the exposed area Dosing of the study product will be done 5 times daily beginning at the time that a subject first senses the start of the prodromal phase The EED is a clear viscous eye drop and the Comparator is a white cream substance Therefore the subject and principal investigator will be unblinded and only efficacy assessments will be done by a qualified trained blinded assessor
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
On Days 34 5 and 6 the subject will follow up via virtual video call with blinded assessors during which the subjects diary card will be reviewed and compliance with dosing checked Video calls will take place on weekedays If however Study Days 3-6 fall on a weekend day virtual video visits will not occur and subjects will be asked to upload photos to a secure private MyChart account If the subject has noted any unusual symptoms these will be discussed with medical personnel to determine if a treatment emergent adverse event has occurred or if the subject has not started treatment whether their medical history should be updated A photo will be taken of the irradiated area as marked on Day 1 and the subject will be discharged and reminded to follow up on Day 7
On Day 7 the subject will 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 and whether or not they have experienced a treatment emergent adverse event If the subject has not experienced any prodromal symptoms or an outbreak of HSV by Day 7 they will be released from the study All other subjects will be asked to upload a photo of the radiated area to their private individual Dropbox folder and asked to continue with dosing as instructed They will be discharged from the clinic with a reminder to return on Day 10
On Day 10 the subject will return to the clinic for assessment of the irradiated area Study staff will review the subject diary to determine if the subject is correctly noting the lesion stage and whether they have experienced a treatment emergent adverse event More study product will be dispensed as needed a photo of the irradiated area will be taken and the subject will be discharged with a reminder call the clinic and schedule an end of study EOS visit as soon as their lesion is healed or at 7 full days of treatment whichever comes first Study staff will ensure that the subject is seen within 24 hours of occurrence of either of these two milestones
The EOS visit is expected to be the final study visit 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 Subjects who developed a lesion that has not yet healed will be given the option to begin taking a prn medication that has been previously prescribed to treat an outbreak
If an adverse event has occurred but has not resolved by the EOS visit the subject will be contacted once weekly and status of the AE noted until such time as the event has resolved
STUDY TREATMENT EDTA Eye Drops Livionex Inc has agreed to supply EED It consists of 26 EDTA plus a permeation enhancer MSM EED will be packaged in standard dropper bottles and labeled as containing 26 EDTA plus MSM as a surfactant
Comparator Abreva Abreva manufactured by Avinir Pharmaceuticals is an antiviral agent approved by the FDA for treatment of cold sores It is packaged in tubes of 2g each
According to WHO in 2012 an estimated 37 billion people under age 50 67 had HSV-1 infection globally Some patients have predictable outbreaks after exposure to noxious stimuli such as sunlight fever menstruation or stress
Researchers have found that calcium signaling is involved in the translocation of the virus from the ganglia to the eruption site It has been found that an increase of calcium levels in the extracellular matrix will precipitate the calcium signaling events that are causal to the migration of the HSV virus from the proximal ganglia to the eruption site Hunsperger 2003 Cheshenko 2003 Further Husperger found in her experiments in vitro that the chelation of calcium greatly reduced the reactivation of the HSV virus
EDTA Eye Drops EED which consists of a calcium chelator and a permeation enhancer could be one such intervention Livionex has had some anecdotal evidence that this intervention could work at preventing an HSV eruption and post prodromal viral shedding
IRB-approved clinical studies of HSV-1 have been performed in normal human volunteers with a history of HSV-1 who develop recurrences with prodromes after exposure to UV light We will use this technique to induce recurrences in susceptible HSV-1 infected individuals then treat with EED or Comparator 5 times daily
Abreva has been chosen as the Comparator product in this study because it is approved by the FDA for treatment of HSV-related cold sores Dosing 5 timesday has been selected as the dosing regimen because that is the dosing regimen approved for Abreva by FDA The manufacturers of Abreva recommend that subjects not be treated for greater than 10 days A maximum of 7 days treatment with study product has been chosen for this study
Thus treatment in both groups of subjects will be 5 times daily and will last until healing of the lesion or up to 7 days following the onset of the prodrome
2 OBJECTIVE To collect preliminary efficacy and safety data on the use of EED in subjects with a history of herpes labialis following UV Radiation
This will be a randomized efficacy assessor-blinded parallel group pilot study of up to 20 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 Baseline visit During the screening period subjects that meet all other entry criteria will undergo UV susceptibility testing to determine their individual MED minimal erythemal dose 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 enroll in the study Each subject will be randomly assigned in a 11 ratio to receive either EED or Comparator
On Day 1 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 photograph may be taken Specifics on the process for UV exposure will be explained in the study manual Subjects will be dispensed study medication and instructed how to apply it to the exposed area Dosing of the study product will be done 5 times daily beginning at the time that a subject first senses the start of the prodromal phase The EED is a clear viscous eye drop and the Comparator is a white cream substance Therefore the subject and principal investigator will be unblinded and only efficacy assessments will be done by a qualified trained blinded assessor
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
On Days 34 5 and 6 the subject will follow up via virtual video call with blinded assessors during which the subjects diary card will be reviewed and compliance with dosing checked Video calls will take place on weekedays If however Study Days 3-6 fall on a weekend day virtual video visits will not occur and subjects will be asked to upload photos to a secure private MyChart account If the subject has noted any unusual symptoms these will be discussed with medical personnel to determine if a treatment emergent adverse event has occurred or if the subject has not started treatment whether their medical history should be updated A photo will be taken of the irradiated area as marked on Day 1 and the subject will be discharged and reminded to follow up on Day 7
On Day 7 the subject will 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 and whether or not they have experienced a treatment emergent adverse event If the subject has not experienced any prodromal symptoms or an outbreak of HSV by Day 7 they will be released from the study All other subjects will be asked to upload a photo of the radiated area to their private individual Dropbox folder and asked to continue with dosing as instructed They will be discharged from the clinic with a reminder to return on Day 10
On Day 10 the subject will return to the clinic for assessment of the irradiated area Study staff will review the subject diary to determine if the subject is correctly noting the lesion stage and whether they have experienced a treatment emergent adverse event More study product will be dispensed as needed a photo of the irradiated area will be taken and the subject will be discharged with a reminder call the clinic and schedule an end of study EOS visit as soon as their lesion is healed or at 7 full days of treatment whichever comes first Study staff will ensure that the subject is seen within 24 hours of occurrence of either of these two milestones
The EOS visit is expected to be the final study visit 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 Subjects who developed a lesion that has not yet healed will be given the option to begin taking a prn medication that has been previously prescribed to treat an outbreak
If an adverse event has occurred but has not resolved by the EOS visit the subject will be contacted once weekly and status of the AE noted until such time as the event has resolved
STUDY TREATMENT EDTA Eye Drops Livionex Inc has agreed to supply EED It consists of 26 EDTA plus a permeation enhancer MSM EED will be packaged in standard dropper bottles and labeled as containing 26 EDTA plus MSM as a surfactant
Comparator Abreva Abreva manufactured by Avinir Pharmaceuticals is an antiviral agent approved by the FDA for treatment of cold sores It is packaged in tubes of 2g each
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None