Randomized, double-blind, multi-center, three arm parallel group, comparative trial to assess pritelivir ointment safety and efficacy, ie, proportion of subjects with non-ulcerative lesions, in adult subjects with recurrent herpes labialis (RHL) in comparison with placebo or Zovirax® Cream. The start of treatment with trial medication will be initiated by the subject within one hour of noticing the first sign or symptom (eg, prodrome) of a recurrence of herpes labialis. Trial medication will be applied to the affected area 5 times daily for 4 days. After self-initiation of treatment with trial medication subjects will be assessed daily by the Investigator until complete healing for a maximum of 13 days. Subjects will document application of trial medication and the status of their lesion in a diary. There will also be blood sampling, ECG measurement and physical examination performed at the investigational site.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
362
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Santa Rosa, California, United States
Unnamed facility
Pinellas Park, Florida, United States
Unnamed facility
Edina, Minnesota, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Akron, Ohio, United States
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Anderson, South Carolina, United States
Unnamed facility
Greer, South Carolina, United States
Unnamed facility
San Antonio, Texas, United States
Efficacy Measured by Percentage of Subjects With Non-ulcerative Lesions Based on Principal Investigator's Assessment
The Investigator assessed subjects for lesion stage at every visit as long as lesions were present from Visit 1 to the End of Trial Visit (Day 12± 1) as a maximum. Percentage of subjects with non-ulcerative lesions (i.e, scoring below 3) based on the Principal Investigators Assessment. Lesion stages were defined as follows: 1-Prodrome; 2a-Redness; 2b-Erythema-Redness; 3-Small Blister; 4-Ulcer; 5-Crust; 6-Drying up and healing; 0-Resolved
Time frame: 13 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.