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.

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