Title
Safety, Pharmacokinetics, and Efficacy Study of NB-001 to Treat Recurrent Herpes Labialis
The Safety, Pharmacokinetics, and Efficacy of NB-001 (0.1%, 0.3%, 0.5%) in Subjects With Recurrent Herpes Labialis
Phase
Phase 2Lead Sponsor
BlueWillow BiologicsStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Herpes LabialisIntervention/Treatment
nb-001 ...Study Participants
1000Purpose of this study is to determine the safety and efficacy of topical applications of NB-001 as compared to placebo for the treatment of recurrent herpes labialis.
Inclusion Criteria: 18 to 80 years of age of either gender Good general health History of recurrent herpes labialis with at least 3 episodes per year Exclusion Criteria: Pregnant and/or nursing female Lesions or irritation on or around the lips that would interfere with recognition of a herpes labialis attack Treatment with topical steroids, antivirals, or new topical products on or around the lips in the week prior to the onset of an attack Known allergies to topical creams, ointments or medications. Other protocol-defined inclusion/exclusion criteria may apply