Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection
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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. |
| ClinicalTrials.gov Identifier: NCT01308424 |
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Recruitment Status :
Completed
First Posted : March 4, 2011
Results First Posted : August 13, 2013
Last Update Posted : August 13, 2013
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Sponsor:
Beech Tree Labs, Inc.
Collaborator:
Norwich Clinical Research Associates Ltd.
Information provided by (Responsible Party):
Beech Tree Labs, Inc.
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Oral Herpes Simplex | Drug: BTL TML HSV Drug: Matching placebo | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 171 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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 |
| Study Start Date : | January 2011 |
| Actual Primary Completion Date : | October 2012 |
| Actual Study Completion Date : | November 2012 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| 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 |
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) ]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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.
| Responsible Party: | Beech Tree Labs, Inc. |
| ClinicalTrials.gov Identifier: | NCT01308424 History of Changes |
| Other Study ID Numbers: |
2010-03-0112 |
| First Posted: | March 4, 2011 Key Record Dates |
| Results First Posted: | August 13, 2013 |
| Last Update Posted: | August 13, 2013 |
| Last Verified: | August 2013 |
Keywords provided by Beech Tree Labs, Inc.:
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Herpes Labialis Herpes Simplex Herpes |
Additional relevant MeSH terms:
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Virus Diseases Herpes Simplex Herpesviridae Infections Stomatitis, Herpetic DNA Virus Infections Skin Diseases, Viral |
Skin Diseases, Infectious Skin Diseases Stomatitis Mouth Diseases Stomatognathic Diseases |