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

This study has been completed.

Study NCT00820534 Information provided by Novartis

First Received on January 9, 2009. Last Updated on December 16, 2010 History of Changes

Results First Received: November 12, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention
Condition:	Cold Sore
Interventions:	Drug: Penciclovir Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study start : 30 dec 2008 Study end : 16 Nov 2009 Hospital out patient clinic

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Cold Sore confirmed by local temperature measurement

Reporting Groups

	Description
Penciclovir	Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
Placebo	Placebo cream every 2 hours during waking hours for 96 hours

Participant Flow: Overall Study

	Penciclovir	Placebo
STARTED	64	62
COMPLETED	64	62
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Penciclovir	Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
Placebo	Placebo cream every 2 hours during waking hours for 96 hours

Baseline Measures

	Penciclovir	Placebo	Total
Number of Participants [units: participants]	64	62	126
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	63	62	125
>=65 years	1	0	1
Age [units: years] Mean ± Standard Deviation	31.4 ± 11.3	31.8 ± 9.3	31.6 ± 10.4
Gender [units: participants]
Female	43	40	83
Male	21	22	43
Region of Enrollment [units: participants]
United Kingdom	64	62	126

Outcome Measures

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1. Primary:

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

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2. Secondary:

Size of the Cold Sore [ Time Frame: 72 hours ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Head of Clinical Research
Organization: Novartis Consumer Health
phone: +4122363311

No publications provided

Responsible Party:	Prof Philip Lamey, Belfast Health and Social Care Trust Royal Victoria Hospital
ClinicalTrials.gov Identifier:	NCT00820534 History of Changes
Other Study ID Numbers:	FPP4-DE-401
Study First Received:	January 9, 2009
Results First Received:	November 12, 2010
Last Updated:	December 16, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency