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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01308424
Recruitment Status : Completed
First Posted : March 4, 2011
Results First Posted : August 13, 2013
Last Update Posted : August 13, 2013
Norwich Clinical Research Associates Ltd.
Information provided by (Responsible Party):
Beech Tree Labs, Inc.

March 2, 2011
March 4, 2011
May 22, 2013
August 13, 2013
August 13, 2013
January 2011
October 2012   (Final data collection date for primary outcome measure)
Proportion of Subjects Who Experience a New Cold Sore Outbreak That Proceeds to the Lesion Stage. Of Those Subjects That Take Study Medication (Experience a New Emerging Cold Sore) Those That Proceed to Lesion Stage (Cold Sore Stage - 3 Vesicle or Above). [ Time Frame: 7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore) ]
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 with the study.
Symptomatic lesions of a oral herpes simplex outbreak [ Time Frame: Daily for 7 days ]
Lesion classification based on diary card and investigator assessment
Complete list of historical versions of study NCT01308424 on Archive Site
Not Provided
Number of participants with adverse events [ Time Frame: The course of the study ]
Review of adverse experiences, laboratory values to access patient safety
Not Provided
Not Provided
Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection
A Randomized, Double-blind, Parallel, Placebo-controlled Study for the Assessment of the Safety and Efficacy of BTL-TML-HSV for the Treatment of Recurrent Symptomatic 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.
Not Provided
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Oral Herpes Simplex
  • Drug: BTL TML HSV
    Sublingual micro-dosing for 7 days
  • Drug: Matching placebo
    sublingual dosing for 7 days
  • Experimental: BTL TML HSV
    Intervention: Drug: BTL TML HSV
  • Placebo Comparator: Matching Placebo
    Intervention: Drug: Matching placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2012
October 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical history of recurrent cold sores averaging 2 or more episodes per year
  • Experiences prodromal symptoms (tingling, burning, itching) of cold sores
  • Herpes Simplex Virus seropositive (by blood test)

Exclusion Criteria:

  • Immuno-suppressed or taking immunosuppressant medication
  • Use of antiviral therapy directly prior and during the study
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Beech Tree Labs, Inc.
Beech Tree Labs, Inc.
Norwich Clinical Research Associates Ltd.
Not Provided
Beech Tree Labs, Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP