CompletedPhase 1/2

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

United States171 participantsStarted 2011-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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).

Timeframe: 7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore)

Trial details

NCT IDNCT01308424

SponsorBeech Tree Labs, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-10

Results submitted2013-05-22

View on ClinicalTrials.gov More Oral Herpes Simplex trials