Herpes labialis in skiers: Randomized clinical trial of acyclovir cream versus placebo

• Published in: Oral surgery, oral medicine, oral pathology, oral radiology and endodontics Vol. 84; no. 6; pp. 641 - 645
• Main Authors: Raborn, G.Wayne, Martel, Alain Y, Grace, Michael G.A, McGaw, W.T
• Format: Journal Article
• Language: English
• Published: St. Louis, MO Mosby, Inc 01-12-1997; Elsevier
• Subjects: Acyclovir - administration & dosage; Acyclovir - adverse effects; Acyclovir - therapeutic use; Administration, Cutaneous; Adult; Antiviral Agents - administration & dosage; Antiviral Agents - adverse effects; Antiviral Agents - therapeutic use; Biological and medical sciences; Chemoprevention; Double-Blind Method; Female; Follow-Up Studies; Herpes Labialis - prevention & control; Human viral diseases; Humans; Infectious diseases; Linear Models; Male; Medical sciences; Ointments; Pain - etiology; Placebos; Safety; Skiing; Sunlight - adverse effects; Viral diseases; Viral diseases with cutaneous or mucosal lesions and viral diseases of the eye; Human; Skin disease; Acyclic nucleoside; Purine nucleoside; Stomatology; Toxicity; Treatment efficiency; Herpes; Recurrent; Infection; Local administration; Chemotherapy; Lip; Treatment; Viral disease; Aciclovir; Antiviral; Clinical trial
• ISSN: 1079-2104; 1528-395X
• DOI: 10.1016/S1079-2104(97)90366-8

Objective.
A randomized, double-blind trial at seven ski sites in Canada and the United States was conducted to compare the effectiveness and the patient tolerance of topically applied 5% acyclovir cream (MAC III formulation) with those of a placebo cream in the prevention of sun-induced herpes labialis lesions.
Study Design.
All subjects had experienced more than three episodes of sun-induced herpes labialis during the previous year. There were 196 subjects enrolled; 5 did not receive medication, and 10 were excluded from the efficacy analysis for protocol violations. There were 191 subjects in the intent-to-treat analysis, and a separate efficacy analysis was done on 181 subjects. Log rank and Fisher exact tests were used in the analysis.
Results.
There was no difference between the two groups at baseline with respect to any clinical or demographic factor. There was no substantial difference between the groups with respect to adverse experiences (15 for acyclovir; 13 for the placebo). The acyclovir group had significantly fewer lesions (
p < 0.01) than the placebo group (21% vs. 40%) during the 4-day follow-up period.
Conclusion.
The acyclovir group was significantly better than the placebo group during the follow-up period. The safety record of the drug was satisfactory; there was no difference between acyclovir and the placebo in side effects or pain. Topically applied 5% acyclovir cream is an effective preventive step for those who are active and exposed to the sun.