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

Beech Tree Labs

Status and phase: Completed; Phase 2; Phase 1

Conditions: Oral Herpes Simplex

Treatments: Drug: Matching placebo; Drug: BTL TML HSV

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01308424

2010-03-0112

Details and patient eligibility

About

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

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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171 participants in 2 patient groups, including a placebo group

BTL TML HSV

Experimental group

Treatment:

Drug: BTL TML HSV

Matching Placebo

Placebo Comparator group

Treatment:

Drug: Matching placebo