Randomized Clinical Study Comparing Compeed Cold Sore Patch to Acyclovir Cream 5% in the Treatment of Herpes Simplex Labialis
Tonny Karlsmark, MD, MDSc1; J. John Goodman, MD2; Yorik Drouault, MD3; Laura Lufrano, RPh4; Gordon W. Pledger, PhD5; and the Cold Sore Study Group.
1Bispebjerg Hospital, Copenhagen, Denmark; 2Hill Top Research, West Palm Beach, Florida; 3Dermexpert, Paris, France; 4Johnson & Johnson, Skillman, New Jersey; 5Johnson & Johnson consultant statistician, Hamilton, Texas. Poster presented at the 14th Meeting of the International Herpes Management Forum - Oct 10-11, 2007 (Croatia).
ABSTRACT
Background: Hydrocolloid technology has been proven effective in treating dermal wounds. A previous study showed that a newly developed thin hydrocolloid patch (Compeed® Cold Sore Patch [CSP]) provided multiple wound healing benefits across all stages of a herpes simplex labialis (HSL) outbreak.
Methods: An assessment of CSP efficacy and safety was conducted in an international, multi-center, assessor-blinded study that enrolled 728 subjects with a history of recurrent HSL. Of these, 351 experienced a HSL outbreak and were randomized to use CSP (n = 179) or acyclovir cream 5% (Zovirax®, n = 172) at the onset of symptoms until the lesion healed, for a maximum of 10 days. The primary end point was the subject’s global assessment of therapy (SGAT)
(0 - 10 scale, 10 = excellent response). Multiple secondary end points included clinician-assessed healing time and subject assessment of lesion protection, noticeability and social embarrassment.
Results: CSP and acyclovir were highly effective (mean SGAT = 7.89 and 8.00, respectively), with no significant difference observed (P=0.65). The difference in median healing times between products was not significant (7.57 days with CSP vs 7.03 days with acyclovir, P=0.37). Both treatments were well tolerated. CSP-treated subjects reported a high level of protection, less noticeable lesions and greater relief of social embarrassment.
Conclusions: This study confirms the efficacy and safety of CSP in treating HSL lesions as a wound. CSP using hydrocolloid technology provides an alternative to topical antivirals in managing HSL lesions, while affording additional benefits of wound protection, discretion and relief of social embarrassment.
