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Clinical TrialsHerpes Labialis TPI-H-221Herpes labialis multicenter Phase 2 trial being conducted in the U.S. This is a multicenter, placebo controlled, randomized, double-blind, subject initiated study of the safety and efficacy of a single, 10-minute, topical iontophoretic application of a novel acyclovir 5 percent gel for the episodic treatment of recurrent herpes labialis. The design of the trial will also allow the comparison of the efficacy of a single iontophoretic treatment with acyclovir gel within one hour of first signs and/or symptoms of a herpetic episode to the efficacy of a single iontophoretic treatment with acyclovir gel six to18 hours after first signs and/or symptoms. 767 subjects were enrolled to treat about 80 subjects in each of three treatment arms. Depending upon how the subject was randomized into the trial, the subject received either: 1) an iontophoretic treatment with active gel within one hour of first signs/and or symptoms, followed six to 18 hours later by a second treatment with placebo gel; 2) an iontophoretic treatment with placebo gel within 1 hour of first signs/and or symptoms, followed six to 18 hours later by a second treatment with active gel; or 3) an iontophoretic treatment with placebo gel within one hour of first signs/and or symptoms, followed six to 18 hours later by a second treatment with placebo gel. After being enrolled and randomized into the study, subjects were sent home with a locked kit containing the iontophoretic device with either active or placebo gel. At first signs and/or symptoms of a recurrent herpetic episode (prodromal or erythema), the lesion was confirmed by telephone interview with the subject and, upon confirmation of the lesion, the subject was given the combination to the locked kit and instructed to begin treatment immediately. The subject was then instructed to return to the clinic within six to 18 hours of first signs and/or symptoms for a second iontophoretic treatment, appropriate to the treatment arm into which they have been randomized, and an evaluation. The subject visited the clinic for daily follow-up evaluations for three to 14 days following the first treatment and were called two weeks after their last clinic visit for a final safety evaluation. Eligibility informationAll enrolled subjects were 18 to 75 years of age. To be enrolled, he or she must also have had a history of recurrent herpes labialis and reported at least three recurrences during the preceding 12 months. To enter the Treatment Phase of the study, the subject must have had a herpes labialis lesion, assessed by the subject and confirmed by telephone contact, to be at either Stage 0 (prodromal) or Stage 1 (erythema), and first signs and/or symptoms must have been detected within one hour of calling the clinic. For questions regarding clinical studies, please contact: Herpes Labialis - ResourcesWeb Sites |