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Trial record 94 of 112 for:    acyclovir

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

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ClinicalTrials.gov Identifier: NCT00820534
Recruitment Status : Completed
First Posted : January 12, 2009
Results First Posted : January 19, 2011
Last Update Posted : April 20, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Cold Sore
Interventions Drug: Penciclovir
Drug: Placebo
Enrollment 126
Recruitment Details Study start : 30 dec 2008 Study end : 16 Nov 2009 Hospital out patient clinic
Pre-assignment Details Cold Sore confirmed by local temperature measurement
Arm/Group Title Penciclovir Placebo
Hide 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
Arm/Group Title Penciclovir Placebo Total
Hide 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 Number of Baseline Participants 64 62 126
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 62 participants 126 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
63
  98.4%
62
 100.0%
125
  99.2%
>=65 years
1
   1.6%
0
   0.0%
1
   0.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 62 participants 126 participants
31.4  (11.3) 31.8  (9.3) 31.6  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 62 participants 126 participants
Female
43
  67.2%
40
  64.5%
83
  65.9%
Male
21
  32.8%
22
  35.5%
43
  34.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 64 participants 62 participants 126 participants
64 62 126
1.Primary Outcome
Title Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Penciclovir Placebo
Hide 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
Overall Number of Participants Analyzed 64 62
Measure Type: Number
Unit of Measure: participants
39 32
2.Secondary Outcome
Title Size of the Cold Sore
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Penciclovir Placebo
Hide 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
Overall Number of Participants Analyzed 64 62
Mean (95% Confidence Interval)
Unit of Measure: square mm
31.7
(20.8 to 42.6)
32.7
(21.3 to 44.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Penciclovir Placebo
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Penciclovir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/64 (0.00%)   0/62 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Penciclovir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/64 (0.00%)   0/62 (0.00%) 
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.
Results Point of Contact
Name/Title: Head of Clinical Research
Organization: Novartis Consumer Health
Phone: +4122363311
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00820534     History of Changes
Other Study ID Numbers: FPP4-DE-401
First Submitted: January 9, 2009
First Posted: January 12, 2009
Results First Submitted: November 12, 2010
Results First Posted: January 19, 2011
Last Update Posted: April 20, 2012