Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection
This study has been completed.
Sponsor:
Beech Tree Labs, Inc.
Collaborator:
Norwich Clinical Research Associates Ltd.
Information provided by (Responsible Party):
Beech Tree Labs, Inc.
ClinicalTrials.gov Identifier:
NCT01308424
First received: March 2, 2011
Last updated: August 12, 2013
Last verified: August 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine if a new treatment is effective for the treatment of recurrent symptomatic oral herpes virus infections.
| Condition | Intervention | Phase |
|---|---|---|
|
Oral Herpes Simplex |
Drug: BTL TML HSV Drug: Matching placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Beech Tree Labs, Inc.:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]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.
| Enrollment: | 171 |
| Study Start Date: | January 2011 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BTL TML HSV |
Drug: BTL TML HSV
Sublingual micro-dosing for 7 days
|
| Placebo Comparator: Matching Placebo |
Drug: Matching placebo
sublingual dosing for 7 days
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308424
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308424
Locations
| United States, Kentucky | |
| University of Kentucky College of Dentistry/Center for Oral Health Research | |
| Lexington, Kentucky, United States, 40536 | |
| United States, New York | |
| School of Dental Medicine, University at Buffalo | |
| Buffalo, New York, United States, 14214 | |
| Family Dentistry | |
| Norwich, New York, United States, 13815 | |
| United States, Pennsylvania | |
| University of Pittsburgh School of Dental Medicine | |
| Pittsburgh, Pennsylvania, United States, 15261 | |
Sponsors and Collaborators
Beech Tree Labs, Inc.
Norwich Clinical Research Associates Ltd.
More Information
| Responsible Party: | Beech Tree Labs, Inc. |
| ClinicalTrials.gov Identifier: | NCT01308424 History of Changes |
| Other Study ID Numbers: | 2010-03-0112 |
| Study First Received: | March 2, 2011 |
| Results First Received: | May 22, 2013 |
| Last Updated: | August 12, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Beech Tree Labs, Inc.:
|
Herpes Labialis Herpes Simplex Herpes |
Additional relevant MeSH terms:
|
Virus Diseases Herpes Simplex Herpesviridae Infections Stomatitis, Herpetic DNA Virus Infections Skin Diseases, Viral |
Skin Diseases, Infectious Skin Diseases Stomatitis Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on September 30, 2016