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Abstract
Objective
The purpose of this study was to further define the therapeutic value of penciclovir
cream in the treatment of sunlight-induced herpes labialis by comparing its efficacy
and tolerability with those of an inactive control (purified water).
Methods
In this randomized, double-blind, placebo-controlled, parallel-group clinical trial,
lesions were induced by exposure to sunlight. Treatment was self-initiated within
1 hour of development of the signs or symptoms of a recurrence.
Results
Healthy male and female patients (mean age, 38.3 years; range, 18 to 81 years) who
had a history of sunlight-induced herpes labialis (mean of 6 recurrences in previous
12 months) applied either penciclovir cream (n = 266) or purified water (n = 275).
Penciclovir cream significantly decreased the time to lesion healing (P < 0.0011), with a reduction in median time of up to 2 days. The efficacy of penciclovir
cream was further supported by a significant reduction in maximum lesion area (P = 0.008), a faster loss of lesion-associated symptoms (P = 0.026), and significant reductions in daily assessments of pain (P ≤ 0.040), itching (P ≤ 0.032), burning (P ≤ 0.028), and tenderness (P ≤ 0.026) as moderate or severe. These effects were reinforced by the results of the
daily selfassessment of lesion attributes, with significantly fewer severe/extreme
assessments of lesion size (P ≤ 0.003), noticeability (P <- 0.003), amount of scab/crust (P <- 0.003), raised/ swollen area (P ≤ 0.040), soreness/tenderness (P <- 0.043), and overall severity (P .001) throughout the study period.
Conclusions
Penciclovir cream has demonstrated efficacy for a broad range of clinically important
outcomes. Significant effects on lesion area, lesion symptoms, and other lesion attributes
extend the clinical efficacy of penciclovir cream beyond lesion healing.
Key words
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References
- Herpes simplex viruses.in: Fields BN Knipe DM Virology. 2nd ed. Raven Press Ltd., New York1990: 1843-1887
- Herpes simplex labialis.in: Sacks SL Straus SE Whitley RJ Griffiths PD Clinical Management of Herpes Viruses. IOS Press, Amsterdam1995: 8-42
- Penciclovir cream for the treatment of herpes simplex labialis: A randomized, multicenter, double-blind, placebo-controlled trial.JAMA. 1997; 277: 1374-1379
- Pathogenesis of recurrent herpes simplex infections.J Invest Dermatol. 1975; 65: 341-346
- The pathogenesis of herpes simplex labialis: Experimental induction of lesions with UV light.J Clin Microbid. 1985; 22: 366-368
- The natural history of ultraviolet radiation-induced herpes simplex labialis and response to therapy with perioral and topical formulations of acyclovir.J Infect Dis. 1991; 163: 728-734
- The natural history of recurrent oral-facial herpes simplex virus infection.in: Semin Dermatol.11. 1992: 200-206
- (Abstract H81)Penciclovir cream for recurrent herpes simplex labialis: An effective new treatment.in: Programs and abstracts of the 36th Annual Meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy, New Orleans, LaSeptember 15–18, 1996
- Phototesting and dosimetry for photochemotherapy.Br J Dermatol. 1977; 96: 1-10
- Skin type, minimal erythema dose (MED) and sunlight acclimatization.J Am Acad Dermatol. 1981; 5: 439-443
- Measurement of natural sunlight exposure required to produce minimal erythema dose on human skin.J Derm Clin Eval Soc. 1992; 3: 28-29
- Prevention of ultraviolet light-induced herpes labialis by sunscreen.Lancet. 1991; 388: 1419-1422
- Regression models and life tables (with discussion).J R Stat Soc. 1972; 34: 187-220
- Successful treatment of herpes labialis with topical acyclovir.Br Med J. 1983; 286: 1699-1701
- Topical acyclovir therapy in patients with recurrent orofacial herpes simplex infections.J Antimicrob Chemother. 1983; 12: 89-93
- Herpes labialis treatment with acyclovir 5% modified aqueous cream: A double-blind, randomized trial.Oral Surg Oral Med Oral Pathol. 1989; 67: 676-679
- Failure of acyclovir cream in treatment of recurrent herpes labialis.Br Med J. 1985; 291: 7-9
Article info
Publication history
Accepted:
November 18,
1999
Identification
Copyright
© 2000 Published by Elsevier Inc.
