Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-27 @ 9:11 AM
Study NCT ID:
NCT01902303
Status:
COMPLETED
Last Update Posted:
2016-04-28
First Post:
2013-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Cold Sore Treatments on Ultra Violet (UV) Induced Cold Sores
Sponsor:
Beech Tree Labs, Inc.
Organization:
Study Overview
Official Title:
Evaluation of Cold Sore Treatments on UV Induced Cold Sores
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if a new drug treatment is effective to block the development of a cold sore lesion following Ultra Violet (UV) exposure.
Detailed Description:
This was a multi-center, randomized, evaluator and subject-blind, placebo controlled study design
The objective of this study was to evaluate the ability of the test articles to block the development of a cold sore lesion from progressing beyond the prodromal stage following a UV-induced process.
The primary efficacy endpoint of this study was to determine if a recurrent oral herpes episode initiated with prodromal symptoms was aborted before progressing to a lesion (vesicle) via assessing lesion stages by a trained evaluator.
The secondary efficacy endpoints included: a) subject self-assessments and b) test article weights and diaries to track treatment compliance.
The objective of this study was to evaluate the ability of the test articles to block the development of a cold sore lesion from progressing beyond the prodromal stage following a UV-induced process.
The primary efficacy endpoint of this study was to determine if a recurrent oral herpes episode initiated with prodromal symptoms was aborted before progressing to a lesion (vesicle) via assessing lesion stages by a trained evaluator.
The secondary efficacy endpoints included: a) subject self-assessments and b) test article weights and diaries to track treatment compliance.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HTR - 13-131178 | OTHER | Hill Top Research | View |