Trial · NCT00769314
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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). |
| Secondary | Patient Assessment of Efficacy of the 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 to rate efficacy of treatment using a 4-point scale (inactive, mildly active, moderately active, or very active). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00769314/registered