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

NCT00820534 | Completed Phase 4 Results

• 1 other identifier: FPP4-DE-401
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cold Sore

Keywords

cold sore

Outcome Measures

Primary Outcomes (1)

• Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.

  Number of participants where the classical cold sore lesion was prevented at 72 hours after first treatment application.Lesion defined as having been prevented if clinical assessment is prodrome, macule or healed and skin temperature of the cold sore is negative (temperature difference of less than 0.5°C between initial site of cold sore and opposite side).

  72 hours

Secondary Outcomes (1)

• Size of the Cold Sore

  72 hours

Study Arms (2)

Penciclovir

EXPERIMENTAL

Penciclovir

Drug: Penciclovir

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Penciclovir DRUG

Penciclovir every 2 hours during waking hours for 96 hours

Penciclovir

Placebo DRUG

Placebo every 2 hous during waking hours for 96 hours

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Belfast Health and Social Care Trust, Royal Victoria Hospital

Belfast, BT12 6BA, United Kingdom

Location

MeSH Terms

Conditions

Herpes Labialis

Interventions

penciclovir

Condition Hierarchy (Ancestors)

Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Head of Clinical Research
• Organization: Novartis Consumer Health

+4122363311

Study Officials

• Philip Lamey

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2009
• First Posted: January 12, 2009
• Study Start: December 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 20, 2012
• Results First Posted: January 19, 2011

Record last verified: 2010-12

Locations

GB (1)