Trial · NCT00769314
Phase 3 Clinical Study for the Treatment of Cold Sore
NCT00769314, Phase 3, Completed, Valerio Therapeutics; results first posted 2012-12-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Clinical Study for the Treatment of Cold Sore. Trials, record NCT00769314. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00769314
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Clinical Study for the Treatment of Cold Sore
- NCT number
- NCT00769314
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,727 participants, actual
- Lead sponsor
- Valerio Therapeutics
- Conditions
- Herpes Labialis
- Interventions
- Acyclovir Lauriad, Placebo
- First posted
- 2008-10-09
- Last updated
- 2012-12-21
- Results first posted
- 2012-12-21
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Healing (TTH) of Vesicular Primary Lesion | Assessed from time of treatment initiation through Day 14 | Healing was defined as the loss of crust (erythema may be present) as assessed by the investigator. TTH was the time from treatment initiation to healing as defined above and was assessed from the time of treatment initiation through Day 14. The primary vesicular lesion was the first developed lesion located on the lip and was not to have extended more than 1 cm outside the lip. |
| Secondary | Abortion of Primary Lesions | Assessed from the time of treatment initiation through Day 14 | Aborted lesions were defined as herpetic lesions preceded by prodromal symptoms that did not progress beyond the papule stage. |
| Secondary | TTH of Non-primary Lesions (Aborted Lesions Excluded) | Assessed from the time of treatment initiation through Day 14 | TTH of non-primary lesions was defined as the time from treatment initiation to healing of all non-primary vesicular lesions. Non-primary lesions were those that developed in addition to and/or in 1 or more days after the primary vesicular lesion and that were located at least 1 cm from the primary lesion. Aborted lesions were not included in this parameter. TTH was to be assessed by the investigator. |
| Secondary | Duration of Episode (DOE) | Assessed from initiation of treatment to Day 14 | For patients who experienced a vesicular lesion, DOE was defined as the time from treatment initiation to healing of primary and secondary vesicular lesions (loss of crust). For subjects whose primary and secondary lesions were not vesicular in nature, DOE was defied as the time from treatment initiation to return to normal skin or to cessation of symptoms, whichever came last. |
| Secondary | Time to Cessation of Symptoms | Assessed from time of treatment initiation through Day 14 | Time to cessation of symptoms was defined as the time from treatment initiation to cessation of all symptoms: pain, burning, itching, tingling, tenderness and discomfort. It was to be assessed by the investigator. |
| Secondary | TTH of Aborted Primary Lesions | Assessed from time of treatment initiation through Day 14 | TTH of aborted primary lesions was defined as the time from treatment initiation to healing of the primary lesion (erythema or papule) or cessation of symptoms, whichever came last. It was to be assessed by the investigator. |
| Secondary | Time to Recurrence of Non-aborted Lesions During 9-month Follow-up | From time of initial healing through the 9-month follow-up | Time to recurrence was the time from the healing of all lesions of the initial episode to the occurrence of new lesions. |
| Secondary | Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up | From time of initial healing through the 9-month follow-up | Recurrence was the occurrence of new lesions and was evaluated in a subgroup of patients who agreed to record recurrences during the 9-month follow-up period. |
| Secondary | Symptom Intensity (Visual Analogue Scale [VAS]) | Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing) | Patients were asked to place a tick mark on a 10 centimeter VAS indicating their symptom intensity. Scale ratings ranged from a minimum of 0 (none at all) to a maximum of 10 (worst possible). The location of the tick mark from "0" was measured in millimeters (0 - 100) and recorded. |
| Secondary | Patient Satisfaction With Treatment | Assessed on Day 14 (or within 24 hours of healing) | At the end of study (Day 14 \[or within 24 hours of healing\]), patients were asked whether they were satisfied with treatment (yes/no). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Abortion of Primary Lesions | Assessed from the time of treatment initiation through Day 14 | This endpoint was analyzed using the Intent-to-Treat (ITT) population, which consisted of all randomized patients who received at least one dose of study medication and who had complete information recorded for the application time. | participants | NUMBER |
| SECONDARY | TTH of Non-primary Lesions (Aborted Lesions Excluded) | Assessed from the time of treatment initiation through Day 14 | This endpoint was analyzed using a subgroup of patients in the ITT population with non-primary lesions. | Days | MEDIAN |
| SECONDARY | Duration of Episode (DOE) | Assessed from initiation of treatment to Day 14 | This endpoint was analyzed using the ITT population. | Days | MEDIAN |
| SECONDARY | Time to Cessation of Symptoms | Assessed from time of treatment initiation through Day 14 | This endpoint was analyzed using the ITT population. | Days | MEDIAN |
| SECONDARY | TTH of Aborted Primary Lesions | Assessed from time of treatment initiation through Day 14 | This endpoint was analyzed using the subgroup of patients within the ITT population with aborted lesions. | Days | MEDIAN |
| PRIMARY | Time to Healing (TTH) of Vesicular Primary Lesion | Assessed from time of treatment initiation through Day 14 | The modified Intent-to-Treat (mITT) population was the population used for analysis of this endpoint. The mITT population included all randomized patients who received at least one dose of study medication and who reached the vesicular stage (ie, episodes that progressed through macula, papule, vesicle, crust and healing). | Days | MEDIAN |
| SECONDARY | Time to Recurrence of Non-aborted Lesions During 9-month Follow-up | From time of initial healing through the 9-month follow-up | This endpoint was analyzed using the follow-up population, a subgroup of the ITT population who continued to the 9 month follow-up and had at least 1 diary assessment during that period. The follow-up population was defined as patients whose lesions were healed at the end of Day 14 and had no recurrence within 15 days of healing of all lesions. | Days | MEDIAN |
| SECONDARY | Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up | From time of initial healing through the 9-month follow-up | This endpoint was analyzed using the follow-up population, a subgroup of the ITT population who continued to the 9 month follow-up and had at least 1 diary assessment during that period. The follow-up population was defined as patients whose lesions were healed at the end of Day 14 and had no recurrence within 15 days of healing of all lesions. | participants | NUMBER |
| SECONDARY | Symptom Intensity (Visual Analogue Scale [VAS]) | Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing) | This endpoint was analyzed using the safety population, which consisted of all randomized patients who took at least 1 dose of study medication. | units on a scale (0 - 100) | MEAN |
| SECONDARY | Patient Satisfaction With Treatment | Assessed on Day 14 (or within 24 hours of healing) | This endpoint was analyzed using the ITT population. | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Abortion of Primary Lesions | Acyclovir Lauriad Group | Aborted Lesions = Yes | 130 | participants | |
| Abortion of Primary Lesions | Placebo Group | Aborted Lesions = Yes | 109 | participants | |
| Abortion of Primary Lesions | Acyclovir Lauriad Group | Aborted Lesions = No | 242 | participants | |
| Abortion of Primary Lesions | Placebo Group | Aborted Lesions = No | 279 | participants | |
| Abortion of Primary Lesions | Acyclovir Lauriad Group | Aborted Lesions = Missing | 4 | participants | |
| Abortion of Primary Lesions | Placebo Group | Aborted Lesions = Missing | 7 | participants | |
| TTH of Non-primary Lesions (Aborted Lesions Excluded) | Acyclovir Lauriad Group | 7.00 | 95% Confidence Interval 5.53 to 8.70 | Days | |
| TTH of Non-primary Lesions (Aborted Lesions Excluded) | Placebo Group | 9.08 | 95% Confidence Interval 7.46 to 11.00 | Days | |
| Duration of Episode (DOE) | Acyclovir Lauriad Group | 5.57 | 95% Confidence Interval 5.03 to 6.01 | Days | |
| Duration of Episode (DOE) | Placebo Group | 6.38 | 95% Confidence Interval 5.93 to 6.97 | Days |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acyclovir Lauriad Group | 378 | |
| Overall Study | STARTED | Placebo Group | 397 | |
| Overall Study | COMPLETED | Acyclovir Lauriad Group | 361 | |
| Overall Study | COMPLETED | Placebo Group | 384 | |
| Overall Study | NOT COMPLETED | Acyclovir Lauriad Group | 17 | |
| Overall Study | NOT COMPLETED | Placebo Group | 13 |
Source ClinicalTrials.gov
Adverse events10
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 |
|---|---|---|---|---|---|---|
| other | headache | Nervous system disorders | Acyclovir Lauriad Group | 12 | 378 | 12 |
| other | headache | Nervous system disorders | Placebo Group | 12 | 397 | 12 |
| other | Nasopharyngitis | Infections and infestations | Acyclovir Lauriad Group | 4 | 378 | 4 |
| other | Nasopharyngitis | Infections and infestations | Placebo Group | 3 | 397 | 3 |
| other | Application Site Pain | General disorders | Acyclovir Lauriad Group | 4 | 378 | 4 |
| other | Application Site Pain | General disorders | Placebo Group | 4 | 397 | 4 |
| other | nausea | Gastrointestinal disorders | Acyclovir Lauriad Group | 1 | 378 | 1 |
| other | nausea | Gastrointestinal disorders | Placebo Group | 6 | 397 | 6 |
| serious | Allergic reaction | Immune system disorders | Acyclovir Lauriad Group | 0 | 378 | 0 |
| serious | Allergic reaction | Immune system disorders | Placebo Group | 1 | 397 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acyclovir Lauriad Group | ||
| Total, all-cause mortality | Placebo Group | ||
| Total, other adverse events | Acyclovir Lauriad Group | 20 | 378 |
| Total, other adverse events | Placebo Group | 22 | 397 |
| Total, serious adverse events | Acyclovir Lauriad Group | 0 | 378 |
| Total, serious adverse events | Placebo Group | 1 | 397 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Acyclovir Lauriad Group vs Placebo Group: serious adverse events |
Source Trial comparisons
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.
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/NCT00769314
GET https://conductscience.org/api/trials/v1/NCT00769314/results?page=2