Trial Outcomes & Findings for Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis (NCT NCT02265913)
NCT ID: NCT02265913
Last Updated: 2021-10-22
Results Overview
Time to complete healing of lesions measured in hours from the time of first dosing
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4076 participants
Primary outcome timeframe
up to 21 days
Results posted on
2021-10-22
Participant Flow
Participant milestones
| Measure |
Test Product
acyclovir cream
Acyclovir 5 percent (Perrigo)
|
Reference Product
acyclovir cream
Acyclovir 5 percent (Reference)
|
Placebo Product
Placebo cream
Placebo cream
|
|---|---|---|---|
|
Overall Study
STARTED
|
1357
|
1361
|
1358
|
|
Overall Study
COMPLETED
|
793
|
810
|
813
|
|
Overall Study
NOT COMPLETED
|
564
|
551
|
545
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis
Baseline characteristics by cohort
| Measure |
Test Product
n=1357 Participants
acyclovir cream
Acyclovir 5 percent (Perrigo)
|
Reference Product
n=1361 Participants
acyclovir cream
Acyclovir 5 percent (Reference)
|
Placebo Product
n=1358 Participants
Placebo cream
Placebo cream
|
Total
n=4076 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.7 years
STANDARD_DEVIATION 15.05 • n=99 Participants
|
43.9 years
STANDARD_DEVIATION 15.20 • n=107 Participants
|
43.3 years
STANDARD_DEVIATION 14.99 • n=206 Participants
|
43.7 years
STANDARD_DEVIATION 15.08 • n=7 Participants
|
|
Sex: Female, Male
Female
|
900 Participants
n=99 Participants
|
915 Participants
n=107 Participants
|
902 Participants
n=206 Participants
|
2717 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
457 Participants
n=99 Participants
|
446 Participants
n=107 Participants
|
456 Participants
n=206 Participants
|
1359 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
278 Participants
n=99 Participants
|
297 Participants
n=107 Participants
|
300 Participants
n=206 Participants
|
875 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1079 Participants
n=99 Participants
|
1064 Participants
n=107 Participants
|
1057 Participants
n=206 Participants
|
3200 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
294 Participants
n=99 Participants
|
284 Participants
n=107 Participants
|
244 Participants
n=206 Participants
|
822 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
1025 Participants
n=99 Participants
|
1037 Participants
n=107 Participants
|
1078 Participants
n=206 Participants
|
3140 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
59 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: up to 21 daysPopulation: per protocol population
Time to complete healing of lesions measured in hours from the time of first dosing
Outcome measures
| Measure |
Test Product
n=633 Participants
acyclovir cream: Acyclovir 5 percent (Perrigo)
|
Reference Product
n=652 Participants
acyclovir cream: Acyclovir 5 percent (Zovirax)
|
Placebo Product
n=641 Participants
vehicle of the test product cream
|
|---|---|---|---|
|
Lesion Healing
|
107.47 hours
Standard Deviation 80.660
|
110.08 hours
Standard Deviation 82.840
|
112.41 hours
Standard Deviation 83.467
|
Adverse Events
Test Product
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Reference Product
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test Product
n=1357 participants at risk
acyclovir cream
Acyclovir 5 percent (Perrigo)
|
Reference Product
n=1361 participants at risk
acyclovir cream
Acyclovir 5 percent (Reference)
|
Placebo Product
n=1358 participants at risk
Placebo cream
Placebo cream
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.07%
1/1357 • Number of events 1 • Up to 21 days
|
0.00%
0/1361 • Up to 21 days
|
0.00%
0/1358 • Up to 21 days
|
|
Vascular disorders
Worsening Of Hypertension
|
0.00%
0/1357 • Up to 21 days
|
0.07%
1/1361 • Number of events 1 • Up to 21 days
|
0.00%
0/1358 • Up to 21 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1357 • Up to 21 days
|
0.07%
1/1361 • Number of events 1 • Up to 21 days
|
0.00%
0/1358 • Up to 21 days
|
|
Cardiac disorders
Atrial Fibrillation
|
0.07%
1/1357 • Number of events 1 • Up to 21 days
|
0.00%
0/1361 • Up to 21 days
|
0.00%
0/1358 • Up to 21 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
0.07%
1/1357 • Number of events 1 • Up to 21 days
|
0.00%
0/1361 • Up to 21 days
|
0.00%
0/1358 • Up to 21 days
|
|
Renal and urinary disorders
Kidney Stone
|
0.00%
0/1357 • Up to 21 days
|
0.07%
1/1361 • Number of events 1 • Up to 21 days
|
0.00%
0/1358 • Up to 21 days
|
|
Injury, poisoning and procedural complications
Right Forearm Fracture
|
0.00%
0/1357 • Up to 21 days
|
0.07%
1/1361 • Number of events 1 • Up to 21 days
|
0.00%
0/1358 • Up to 21 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER