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NCT01308424 · ClinicalTrials.gov registry record · Phase 1

Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection

A Phase 1 study, sponsored by Beech Tree Labs.

Completed
Registry status
Phase 1
Development phase
171
Enrollment target

NCT01308424: Completed Phase 1 study, sponsored by Beech Tree Labs.

NCT01308424 is a Phase 1 study that has completed, run by Beech Tree Labs. The registered enrollment target is 171 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (185% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01308424, a Phase 1 study, has completed, sponsored by Beech Tree Labs.

COMPLETED
Registry status
Phase 1
Development phase
171 participants
Enrollment target

Study Summary

The purpose of this study is to determine if a new treatment is effective for the treatment of recurrent symptomatic oral herpes virus infections.

Primary Outcome

Subjects start a daily diary based on start of symptoms of a new emerging cold sore and start taking study medication. Subjects note the start time of study medication along with cold sore stage(s)for at least 7 days and up to 14 days. Subjects take study medication for 7 days. Cold Sore stages are 0=Dormant, 1=Prodrome, 2=Inflammation, 3=Vesicle, 4=Ulcer, 5=Crust, 6=Healed. If subjects do not experience a new cold sore outbreak within 7 days, they do not take study medication and are completed

Interventions

  • DRUG Matching placebo
  • DRUG BTL TML HSV

Trial Details

FieldValue
Enrollment Target 171 participants
Start Date 2011-01
Est. Completion 2012-11
Phase Phase 1
Beech Tree Labs

4 total trials

What the finished NCT01308424 record still lists

NCT01308424 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (185% higher).

The record links to 0 conditions, and to 2 interventions - of which Matching placebo is the first listed.

NCT01308424 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01308424 about?

NCT01308424 is a clinical study titled "Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection". The purpose of this study is to determine if a new treatment is effective for the treatment of recurrent symptomatic oral herpes virus infections.

What is the current status of trial NCT01308424?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 171 participants. The study started on 2011-01. Estimated completion is 2012-11.

What interventions are being tested in trial NCT01308424?

The interventions under investigation include: Matching placebo (DRUG), BTL TML HSV (DRUG).

Who is sponsoring clinical trial NCT01308424?

This trial is sponsored by Beech Tree Labs, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01308424's enrollment target sits among peer trials

171 324th of 2000 higher than 1,676 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01308424, the US trial registry maintained by the National Library of Medicine. NCT01308424 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.