This is a study to test the hypothesis that time to healing of a cold sore will be lower in the active treatment arm of the study when compared to the vehicle (placebo). Subjects with a history of cold sores will be enrolled and administered active treatment or placebo in a blinded manner. Subjects will then be followed to assess time to healing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
362
Topical administration at least five times throughout the day
Radiant Research, Inc
Chandler, Arizona, United States
Radiant Research, Inc
Tucson, Arizona, United States
Radiant Research, Inc. Chicago
Chicago, Illinois, United States
Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator.
Time to healing is the time from receiving the combination to unlock the medication and begin treatment to investigator assessed healing.
Time frame: Time to healing will be assessed from treatment onset to resolution of symptoms (maximum of 16 days)
Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage
This analysis will be performed in the cohort of subjects whose primary lesion complex is assessed as being in the Prodrome (pain, burning, tingling, itching, redness, swelling, or a tight sensation of the lip), Erythema/Macule, Papule/Edema, or Aborted Stage by the investigator at the first post-treatment visit.
Time frame: Proportion of subjects in whom the primary lesion complex does not progress will be assessed from treatment onset to resolution of symptoms (maximum of 16 days)
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Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
Radiant Research, Inc.
Edina, Minnesota, United States
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, United States
Radiant Research, Inc.
St Louis, Missouri, United States
Radiant Research, Inc.
Anderson, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Research Across America
Dallas, Texas, United States
...and 2 more locations