Trial Outcomes & Findings for A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers (NCT NCT00820534)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

126 participants

Primary outcome timeframe

72 hours

Results posted on

2012-04-20

Participant Flow

Study start : 30 dec 2008 Study end : 16 Nov 2009 Hospital out patient clinic

Cold Sore confirmed by local temperature measurement

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	64	62
Overall Study COMPLETED	64	62
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Penciclovir n=64 Participants Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours	Placebo n=62 Participants Placebo cream every 2 hours during waking hours for 96 hours	Total n=126 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	63 Participants n=5 Participants	62 Participants n=7 Participants	125 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age Continuous	31.4 years STANDARD_DEVIATION 11.3 • n=5 Participants	31.8 years STANDARD_DEVIATION 9.3 • n=7 Participants	31.6 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	40 Participants n=7 Participants	83 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Region of Enrollment United Kingdom	64 participants n=5 Participants	62 participants n=7 Participants	126 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Penciclovir n=64 Participants Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours	Placebo n=62 Participants Placebo cream every 2 hours during waking hours for 96 hours
Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.	39 participants	32 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Penciclovir n=64 Participants Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours	Placebo n=62 Participants Placebo cream every 2 hours during waking hours for 96 hours
Size of the Cold Sore	31.7 square mm Interval 20.8 to 42.6	32.7 square mm Interval 21.3 to 44.2

Adverse Events

Penciclovir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Head of Clinical Research

Novartis Consumer Health

Phone: +4122363311

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place