Efficacy and Safety of Aciclovir Mucoadhesive Buccal Tablet in Immunocompetent Patients With Labial Herpes (LIP Trial): A Double-Blind, Placebo-Controlled, Self-Initiated Trial
July 2014 | Volume 13 | Issue 7 | Original Article | 791 | Copyright © July 2014
Thomas Bieber MD,a Olivier Chosidow MD PhD,b Neil Bodsworth MD,c Stephen Tyring MD,d
Jana Hercogova MD,e Mark Bloch MD,f Matthew Davis MD,g Michael Lewis MD,h
David Boutolleau MD,i Pierre Attali MD MSc,j and the LIP Study Group
aDepartment of Dermatology and Allergy, University of Bonn, Bonn, Germany
bDepartment of Dermatology, Hospital Henri Mondor, Creteil, France
cTaylor Square Private Clinic, Darlinghurst, Australia
dDepartment of Dermatology, University of Texas Health Science Center, Houston, TX
eDermatovenereology Department, Bulovka Hospital, Prague, Czech Republic
fHoldsworth House Medical Practice, Darlinghurst, Australia
gRochester Clinical Research, Rochester, NY
hSchool of Dentistry, College of Biomedical and Life Sciences, Cardiff, UK
iVirology Department, Hospital Pitie-Salpetriere, Paris, France
jBioAlliance Pharma, Paris, France
METHODS: In this multicenter double-blind placebo-controlled patient-initiated trial, 775 patients with recurrent HL were randomly assigned to either a single application of ABT 50 mg or a matching placebo as soon as prodromal symptoms occurred. The primary endpoint was the time to healing (TTH) of primary vesicular lesion (modified intention-to-treat population). Other endpoints included incidence of blocked episodes, duration of herpes episodes, and incidence and time to next recurrence evaluated during a 9-month follow-up period (intention-to-treat population).
RESULTS: With ABT 50 mg, median TTH of primary vesicular lesion was reduced (7 days vs 7.3 days, P=.015), the incidence of blocked herpes episodes was increased by 24.2% (34.9% vs 28.1%; P=.042), and the median duration of herpes episodes was reduced (5.6 days vs 6.4 days, P=.003). During the 9-month follow-up period, recurrence of herpes lesions was less frequent (64.2% vs 73.6%; P=.027) and delayed (205 days vs 165 days, P=.041) in the ABT 50 mg. Both treatments were safe.
CONCLUSION: A single application of ABT improves all endpoints of HL and might modify its clinical course in decreasing the incidence and delaying the onset of the next recurrence.
J Drugs Dermatol. 2014;13(7):791-798.