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GIORNALE ITALIANO DI DERMATOLOGIA E VENEREOLOGIA
A Journal on Dermatology and Sexually Transmitted Diseases
Official Journal of the Italian Society of Dermatology and Sexually Transmitted Diseases
Indexed/Abstracted in: EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 1,014
Giornale Italiano di Dermatologia e Venereologia 2007 June;142(3):215-21
Safety and local tolerability of a new topical formulation (Liquipatch®) of acyclovir lidocaine gel in the treatment of Herpes Simplex labialis. A pivotal clinical trial
Shemer A. 1, Alvino S. 2
1 Laniado Medical Center, Daniel Clinic, Netanya, Israel
2 Research and Development Mipharm S.p.A. Milan, Italy
Aim. Aim of this study was to evaluate: local tolerability, safety and time to healing of a new acyclovir-lidocaine (MI-LP-01) formulation for the treatment of Herpes Simplex virus (HSV).
Methods. A total of 15 patients were enrolled in a single-centre, open-label study. Local tolerability was evaluated on symptoms reported by patients and objective data reported by investigators during treatment. The gel was applied topically on lesion area 5 times/day every 4 h from a minimum of 5 days to a maximum of 10 days. Evaluation of the results was performed at baseline and at day 3, day 6 and day 10. Patients safety was monitored throughout the study for adverse events.
Results. All the 15 enrolled patients completed the study. Global assessment of local tolerability in 15 subject had a score of 5 (very good) in all visits. In 1 patient (visit 3) local tolerability had scored 4 (good). Therefore the product shows a local tolerability good or very good in 100% of the treated patients. Moreover, the gel resulted in a significant reduction of the mean time to healing which was 4.2±2 days in comparison with data reported for acyclovir cream formulation which is 5±6 days. No side effects were reported during the study.
Conclusion. MI-LP-01 has shown to be a well tolerated, safe and effective topical treatment for HSV infection. However, further controlled clinical trial with adeguate sample size are warranted to compare the efficacy and tolerability profile of this new acyclovir-lidocaine formulation with standard therapy.