Trial Outcomes & Findings for EDTA Eye Drops Compared to Abreva for Herpes Simplex Virus Eruptions (NCT NCT04893577)
NCT ID: NCT04893577
Last Updated: 2025-10-31
Results Overview
We will measure the number of days until lesion is healed from start of lesion to lesion resolved.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Up to 14 days per patient
Results posted on
2025-10-31
Participant Flow
Participant milestones
| Measure |
Study Drug (EDTA Eye Drops)
Patients will treat herpes simplex eruption with EDTA eye drops.
EDTA: Patients will treat their cold sore with EDTA eye drops based upon their randomization.
|
Active Comparator (Abreva)
Patients will treat herpes simplex eruption with Abreva.
Abreva: Patients will treat their cold sore with Abreva based upon their randomization
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EDTA Eye Drops Compared to Abreva for Herpes Simplex Virus Eruptions
Baseline characteristics by cohort
| Measure |
Study Drug (EDTA Eye Drops)
n=5 Participants
Patients will treat herpes simplex eruption with EDTA eye drops.
EDTA: Patients will treat their cold sore with EDTA eye drops based upon their randomization.
|
Active Comparator (Abreva)
n=5 Participants
Patients will treat herpes simplex eruption with Abreva.
Abreva: Patients will treat their cold sore with Abreva based upon their randomization
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
46 years
n=5 Participants
|
36.2 years
n=7 Participants
|
41.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days per patientWe will measure the number of days until lesion is healed from start of lesion to lesion resolved.
Outcome measures
| Measure |
Study Drug (EDTA Eye Drops)
n=5 Participants
Patients will treat herpes simplex eruption with EDTA eye drops.
EDTA: Patients will treat their cold sore with EDTA eye drops based upon their randomization.
|
Active Comparator (Abreva)
n=5 Participants
Patients will treat herpes simplex eruption with Abreva.
Abreva: Patients will treat their cold sore with Abreva based upon their randomization
|
|---|---|---|
|
Duration (Days) of Herpes Labialis Outbreak Until Healed
|
10.6 days
Interval 8.0 to 13.0
|
8.25 days
Interval 3.0 to 14.0
|
Adverse Events
Study Drug (EDTA Eye Drops)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Active Comparator (Abreva)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Study Drug (EDTA Eye Drops)
n=5 participants at risk
Patients will treat herpes simplex eruption with EDTA eye drops.
EDTA: Patients will treat their cold sore with EDTA eye drops based upon their randomization.
|
Active Comparator (Abreva)
n=5 participants at risk
Patients will treat herpes simplex eruption with Abreva.
Abreva: Patients will treat their cold sore with Abreva based upon their randomization
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Burning during application of study drug
|
40.0%
2/5 • Number of events 2 • Adverse events were collected over 12 days from beginning of randomization to end of study and 2 day follow-up call.
|
0.00%
0/5 • Adverse events were collected over 12 days from beginning of randomization to end of study and 2 day follow-up call.
|
Additional Information
Christopher Hull, MD
University of Utah MidValley Dermatology
Phone: 801-213-0375
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place