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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00820534
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 11.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cold Sore	Drug: Penciclovir; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Randomised, Double-blind, Vehicle Controlled, Single Center, Parallel Group, Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Penciclovir Penciclovir	Drug: Penciclovir; Penciclovir every 2 hours during waking hours for 96 hours
Placebo Comparator: Placebo Placebo	Drug: Placebo; Placebo every 2 hous during waking hours for 96 hours

Outcome Measures

Primary Outcome Measures

1. Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore. [72 hours]

   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).

Secondary Outcome Measures

1. Size of the Cold Sore [72 hours]

   The size of the cold sore was measured as follows : a standardized photograph was taken before treatment and compared to a photograph taken 72 hours after the first treatment application. The difference was calculated for each participant within each treatment arm.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Belfast Health and Social Care Trust, Royal Victoria Hospital	Belfast		United Kingdom	BT12 6BA

Sponsors and Collaborators

• Novartis

Investigators

• Principal Investigator: Philip Lamey, Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00820534
• Other Study ID Numbers: FPP4-DE-401
• First Posted: Jan 12, 2009
• Last Update Posted: Apr 20, 2012
• Last Verified: Dec 1, 2010

• Keywords provided by Novartis: cold sore
• Additional relevant MeSH terms: Herpes Labialis; Penciclovir

Study Results

Participant Flow

Recruitment Details	Study start : 30 dec 2008 Study end : 16 Nov 2009 Hospital out patient clinic
Pre-assignment Detail	Cold Sore confirmed by local temperature measurement

Arm/Group Title	Penciclovir	Placebo
Arm/Group Description	Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours	Placebo cream every 2 hours during waking hours for 96 hours
Period Title: Overall Study
STARTED	64	62
COMPLETED	64	62
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Penciclovir	Placebo	Total
Arm/Group Description	Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours	Placebo cream every 2 hours during waking hours for 96 hours	Total of all reporting groups
Overall Participants	64	62	126
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	63 98.4%	62 100%	125 99.2%
>=65 years	1 1.6%	0 0%	1 0.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.4 (11.3)	31.8 (9.3)	31.6 (10.4)
Sex: Female, Male (Count of Participants)
Female	43 67.2%	40 64.5%	83 65.9%
Male	21 32.8%	22 35.5%	43 34.1%
Region of Enrollment (participants) [Number]
United Kingdom	64 100%	62 100%	126 100%

Outcome Measures

1. Primary Outcome

Title	Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.
Description	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).
Time Frame	72 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Penciclovir	Placebo
Arm/Group Description	Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours	Placebo cream every 2 hours during waking hours for 96 hours
Measure Participants	64	62
Number [participants]	39 60.9%	32 51.6%

2. Secondary Outcome

Title	Size of the Cold Sore
Description	The size of the cold sore was measured as follows : a standardized photograph was taken before treatment and compared to a photograph taken 72 hours after the first treatment application. The difference was calculated for each participant within each treatment arm.
Time Frame	72 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Penciclovir	Placebo
Arm/Group Description	Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours	Placebo cream every 2 hours during waking hours for 96 hours
Measure Participants	64	62
Mean (95% Confidence Interval) [square mm]	31.7	32.7

Adverse Events

Arm/Group Title	Penciclovir		Placebo
Arm/Group Description	Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours		Placebo cream every 2 hours during waking hours for 96 hours
All Cause Mortality
	Penciclovir		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Penciclovir		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/62 (0%)
Other (Not Including Serious) Adverse Events
	Penciclovir		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/62 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.