A randomized clinical study comparing Compeed® cold sore patch to acyclovir cream 5% in the treatment of herpes simplex labialis

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A randomized clinical study comparing Compeed® cold sore patch to acyclovir cream 5% in the treatment of herpes simplex labialis

By: Tonny Karlsmark, MD, MDSc, Bispebjerg Hospital, Copenhagen, Denmark
J. John Goodman, MD, Hilltop Research, West Palm Beach, Florida
Yorik Drouault, MD, Dermexpert, Paris, France
Laura Lufrano, RPh, Johnson & Johnson, Skillman, New Jersey
Gordon Pledger, PhD, Hamilton, TX
and the Cold Sore Study Group

Developed by: Deborah E. Pan
Jennifer L. Darby, PharmD
Scientific Therapeutics Information, Inc, Springfield, New Jersey

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 as a wound. CSP using hydrocolloid technology provides an alternative to topical antivirals in managing HSL, while affording additional benefits of wound protection, discretion and relief of social embarrassment.

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Last Updated : 04/12/2007 11:37:24