Recent Approval of Xerese in Canada: 5% Acyclovir and 1% Hydrocortisone Topical Cream in the Treatment of Herpes Labialis

Harrison P. Nguyen, BA; Kelly R. Stiegel, BS; Christopher Downing, MD; Stephen K. Tyring, MD, PhD, MBA


Skin Therapy Letter. 2014;19(3) 

In This Article

Adverse Effects

The combination cream of 5% acyclovir and 1% hydrocortisone has been shown to induce only minimal side effects when used to treat herpes labialis infections. In Strand et al's 2012 Phase 3, open-label, multicenter study, 131 of 134 subjects were categorized with recurrence at the post-treatment visit.[10] Of these 131 subjects, only 5 reported any adverse events. The events were classified as mild to moderate in intensity and consisted of secondary herpes labialis recurrences (n=2), infectious rhinitis (n=1), application site inflammation (n=1), and bronchial asthma (n=1). Additional studies have corroborated the safety of ACHC, observing only minor side effects.[11,12] The most common adverse reactions reported in clinical trials were drying or flaking of the skin, burning or tingling at the application sight, erythema, and pigmentation changes; these infrequent adverse effects occurred in less than 1% of patients studied.[5]