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

NCT ID: NCT01308424

Last Updated: 2013-08-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-11-30

Brief Summary

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

Detailed Description

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Conditions

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Oral Herpes Simplex

Keywords

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Herpes Labialis Herpes Simplex Herpes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BTL TML HSV

Group Type EXPERIMENTAL

BTL TML HSV

Intervention Type DRUG

Sublingual micro-dosing for 7 days

Matching Placebo

Group Type PLACEBO_COMPARATOR

Matching placebo

Intervention Type DRUG

sublingual dosing for 7 days

Interventions

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BTL TML HSV

Sublingual micro-dosing for 7 days

Intervention Type DRUG

Matching placebo

sublingual dosing for 7 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beech Tree Labs, Inc.

INDUSTRY

Sponsor Role lead

Norwich Clinical Research Associates Ltd.

OTHER

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Kentucky College of Dentistry/Center for Oral Health Research

Lexington, Kentucky, United States

Site Status

School of Dental Medicine, University at Buffalo

Buffalo, New York, United States

Site Status

Family Dentistry

Norwich, New York, United States

Site Status

University of Pittsburgh School of Dental Medicine

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Mamber SW, Hatch T, Miller CS, Murray JV, Strout C, McMichael J. Low-dose Oral Thimerosal for the Treatment of Oral Herpes: Clinical Trial Results and Improved Outcome After Post-hoc Analysis. J Evid Based Integr Med. 2022 Jan-Dec;27:2515690X221078004. doi: 10.1177/2515690X221078004.

Reference Type DERIVED
PMID: 35142535 (View on PubMed)

Other Identifiers

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2010-03-0112

Identifier Type: -

Identifier Source: org_study_id