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NCT01574612 · ClinicalTrials.gov registry record · Phase 3
Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old
A Phase 3 study of Herpes Labialis, sponsored by Meda Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 54
- Enrollment target
- 10
- Study locations
NCT01574612: Completed Phase 3 study of Herpes Labialis, sponsored by Meda Pharmaceuticals.
NCT01574612 is a Phase 3 study of Herpes Labialis that has completed, run by Meda Pharmaceuticals. The registered enrollment target is 54 participants, below the 1,054-participant average among 6 other Herpes Labialis trials with a reported enrollment target (95% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01574612, a Phase 3 study of Herpes Labialis, has completed, sponsored by Meda Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 54 participants
- Enrollment target
- 10
- Study locations
Study Summary
To test the safety of Xerese (acyclovir and hydrocortisone)Cream 5%/1% for the treatment of recurrent cold sores in children ages 6-11yrs after 5 days of treatment.
Primary Outcome
treatment period is for 5 days and follow up visits at 7days and 21 days after first dose
Conditions Studied
Interventions
- DRUG acyclovir/hydrocortisone cream
Study Locations (10)
Florida
- Sunshine Research Center - Opa-locka
- Altus Rsearch,INC - West Palm Beach
California
- MCS Clinical Trials - Los Angeles
Illinois
- Provident Clincal Research - Addison
Kentucky
- Central Kentucky Research - Lexington
New York
- Rochester Clinical Research - Rochester
North Carolina
- PGM Research of Winston-Salem, LLC - Winston-Salem
Rhode Island
- Clinical Partners LLC - Johnston
Texas
- Corsicana Medical Research,PNC - Corsicana
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-02 |
| Phase | Phase 3 |
What the finished NCT01574612 record still lists
NCT01574612 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 1,054-participant average among 6 other Herpes Labialis trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Herpes Labialis appearing as the primary indexed condition, and to 1 intervention - of which acyclovir/hydrocortisone cream is the first listed.
NCT01574612 lists 10 locations in 9 states (Florida, California, Illinois).
Frequently Asked Questions
What is clinical trial NCT01574612 about?
NCT01574612 is a clinical study titled "Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old". To test the safety of Xerese (acyclovir and hydrocortisone)Cream 5%/1% for the treatment of recurrent cold sores in children ages 6-11yrs after 5 days of treatment.
What is the current status of trial NCT01574612?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 54 participants. The study started on 2012-03. Estimated completion is 2013-02.
What conditions does trial NCT01574612 study?
This clinical trial studies the following conditions: Herpes Labialis.
What interventions are being tested in trial NCT01574612?
The interventions under investigation include: acyclovir/hydrocortisone cream (DRUG).
Who is sponsoring clinical trial NCT01574612?
This trial is sponsored by Meda Pharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01574612 being conducted?
This trial has 10 study locations across California, Florida, Illinois, Kentucky, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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