Trial · NCT02265913

Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis

NCT02265913, Phase 3, Completed, Padagis LLC; results first posted 2021-01-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis. Trials, record NCT02265913. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02265913

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis
NCT number: NCT02265913
Status: Completed
Phases: Phase 3
Enrollment: 4,076 participants, actual
Lead sponsor: Padagis LLC
Conditions: Herpes Labialis
Interventions: Acyclovir 5 percent (Perrigo), Acyclovir 5 percent (Reference), Placebo cream
First posted: 2014-10-16
Last updated: 2021-10-22
Results first posted: 2021-01-05

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Lesion Healing	up to 21 days	Time to complete healing of lesions measured in hours from the time of first dosing

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Lesion Healing	up to 21 days	per protocol population	hours	MEAN

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Lesion Healing	Test Product	107.47	Standard Deviation 80.660	hours
Lesion Healing	Reference Product	110.08	Standard Deviation 82.840	hours
Lesion Healing	Placebo Product	112.41	Standard Deviation 83.467	hours

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Test Product	1,357
Overall Study	STARTED	Reference Product	1,361
Overall Study	STARTED	Placebo Product	1,358
Overall Study	COMPLETED	Test Product	793
Overall Study	COMPLETED	Reference Product	810
Overall Study	COMPLETED	Placebo Product	813
Overall Study	NOT COMPLETED	Test Product	564
Overall Study	NOT COMPLETED	Reference Product	551
Overall Study	NOT COMPLETED	Placebo Product	545

Source ClinicalTrials.gov

Adverse events21

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Test Product	1	1,357	1
serious	Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Reference Product	0	1,361	0
serious	Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Placebo Product	0	1,358	0
serious	Worsening Of Hypertension	Vascular disorders	Test Product	0	1,357	0
serious	Worsening Of Hypertension	Vascular disorders	Reference Product	1	1,361	1
serious	Worsening Of Hypertension	Vascular disorders	Placebo Product	0	1,358	0
serious	Dehydration	Metabolism and nutrition disorders	Test Product	0	1,357	0
serious	Dehydration	Metabolism and nutrition disorders	Reference Product	1	1,361	1
serious	Dehydration	Metabolism and nutrition disorders	Placebo Product	0	1,358	0
serious	Atrial Fibrillation	Cardiac disorders	Test Product	1	1,357	1

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Test Product	0	1,357
Total, all-cause mortality	Reference Product	0	1,361
Total, all-cause mortality	Placebo Product	0	1,358
Total, other adverse events	Test Product	0	1,357
Total, other adverse events	Reference Product	0	1,361
Total, other adverse events	Placebo Product	0	1,358
Total, serious adverse events	Test Product	2	1,357
Total, serious adverse events	Reference Product	4	1,361
Total, serious adverse events	Placebo Product	0	1,358

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02265913

GET https://conductscience.org/api/trials/v1/NCT02265913/events?page=2

API reference For AI assistants