Iontophoretic Application of Acyclovir Gel to Treat Cold Sores
Condition: Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Study type: Interventional
Phase: Phase 2

Summary: 
      Currently approved drugs for the treatment of herpes labialis (cold sores) exhibit low levels
      of efficacy due to the limited ability of the drugs to penetrate the skin to the sites where
      the herpes virus is replicating. Iontophoresis uses electric current to enhance delivery of
      drugs through the skin. This trial is testing a new iontophoretic device with a new acyclovir
      gel to treat cold sores.
    

Detailed description: 
      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% 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 1 hour of first signs and/or symptoms of a herpetic episode to the
      efficacy of a single iontophoretic treatment with acyclovir gel 6 to18 hours after first
      signs and/or symptoms. Approximately 810 subjects will be enrolled to treat about 80 subjects
      in each of three treatment arms. Depending upon how the subject has been randomized into the
      trial, the subject will receive either: 1) an iontophoretic treatment with active gel within
      1 hour of first signs/and or symptoms, followed 6-18 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 6-18 hours later by a second treatment with active gel; or 3) an
      iontophoretic treatment with placebo gel within 1 hour of first signs/and or symptoms,
      followed 6-18 hours later by a second treatment with placebo gel. After being enrolled and
      randomized into the study, subjects will be 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 will be confirmed by telephone
      interview with the subject and, upon confirmation of the lesion, the subject will be given
      the combination to the locked kit and instructed to begin treatment immediately. The subject
      will then be instructed to return to the clinic within 6 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 will visit the clinic for daily
      follow-up evaluations for 3 to 14 days following the first treatment and will be called 2
      weeks after their last clinic visit for a final safety evaluation.
    

Intervention name(s): Iontophoretic delivery of acyclovir
Intervention type(s): Drug
Intervention MeSH terms: Acyclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: herpes labialis; cold sore; acyclovir; iontophoresis; topical