Phase 4 N=126 Randomized Double-blind Prevention

A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers

Cold Sore

Bottom Line

View on ClinicalTrials.gov: NCT00820534 ↗

Enrolled (actual)

126

Serious AEs

0.0%

Results posted

Jan 2011

Primary outcome: Primary: Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore. — 39; 32 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Penciclovir (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis
Primary completion: Nov 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.	39; 32	—
SECONDARY Size of the Cold Sore	31.7; 32.7	—

Summary

Comparison of the efficacy of penciclovir 10 mg/g (1%) cream with that of vehicle at 72 hours in preventing the appearance of classical lesions following prodromal symptoms (tingling or burning sensation) based on thermographic assessment among recurrent cold sore sufferers.

Eligibility Criteria

Inclusion Criteria

Be known to be a cold sore sufferer and presenting a prodromal stage with pain
Sign the written informed consent form prior to enrolment in the trial;
Be aged 18 to 75 years;

Exclusion Criteria

If female, are pregnant, planning pregnancy or lactating;
Have a known hypersensitivity to penciclovir or any ingredients of the vehicle;
Have already ongoing classical cold sore lesions at the baseline visit;
Have taken any cold sore product, analgesic or NSAID in the 24 hours before the baseline visit;
Have applied a cosmetic lip balm on their lips in the 12 hours before the baseline thermographic assessment;
Are known to be immunosuppressed (acquired, congenital or therapeutic);
Have been involved in any investigational protocol within the 30 days prior to the trial;
Have evidence or history of drug or alcohol abuse;

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00820534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.