The purpose of this study is to evaluate the episode duration of a herpes labialis recurrence in immunocompromised patients treated with ME-609 or Acyclovir.
The objective of this study was to evaluate the episode duration of a herpes labialis recurrence, following a 5-day treatment with 5-time daily topical administration of ME-609 or acyclovir cream, in immunocompromised adults, 18 years and older. This interim report summarizes the results for short-term observations, i.e., during the initial study recurrence. A final study report will be prepared when the long-term follow-up is completed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
201
Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application
Dosage form: Cream Dose and regimen: 5 times daily during 5 days Route of administration: Topical application
The primary variable was episode duration, measured from the start of treatment until loss of hard crust for an ulcerative recurrence and from the start of treatment to time of no signs or symptoms for a non-ulcerative recurrence (Investigator-assessed).
Time frame: from start of treatment until loss of hard crust
The secondary variable was the time to next recurrence measured from the start of the study recurrence until the start of the next recurrence.
Time frame: Start of recurrence until start of next recurrence
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