Phase 4
Completed N=126
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
Source: ClinicalTrials.gov NCT00820534 ↗
Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcomePrimary: Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore. — 39; 32 participants
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.
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 | — |
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;
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. Informational only — not medical advice.