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Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01574612
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : May 22, 2014
Last Update Posted : May 22, 2014
Sponsor:
Collaborator:
TKL Research, Inc.
Information provided by (Responsible Party):
Meda Pharmaceuticals

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Herpes Labialis
Intervention Drug: acyclovir/hydrocortisone cream
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Topical Cream
Hide Arm/Group Description

commercial product being used

acyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days

Period Title: Overall Study
Started 54 [1]
Completed 46
Not Completed 8
Reason Not Completed
Adverse Event             3
non compliant with drug             2
Withdrawal by Subject             1
Lost to Follow-up             2
[1]
patients who were identified as having the appropriate medical history of herpes labialis
Arm/Group Title Topical Cream
Hide Arm/Group Description xerese topical cream is the only active used in this trial
Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants
9.1  (1.7)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
<=18 years
54
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
31
  57.4%
Male
23
  42.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 54 participants
54
age of subjects with prior history of herpes labialis outbreak  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
less than or equal to 3 years 27
age 4 to 6 years 17
age 7 to 9 years 10
1.Primary Outcome
Title Reporting of Adverse Events
Hide Description treatment period is for 5 days and follow up visits at 7days and 21 days after first dose
Time Frame day 1 to day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topical Cream
Hide Arm/Group Description:
commercial cream used
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: participants
9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Topical Cream
Hide Arm/Group Description

commercial product being used

acyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days

All-Cause Mortality
Topical Cream
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Topical Cream
Affected / at Risk (%)
Total   0/54 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.9%
Topical Cream
Affected / at Risk (%)
Total   9/54 (16.67%) 
Gastrointestinal disorders   
paresthesia oral   1/54 (1.85%) 
General disorders   
general disorder   1/54 (1.85%) 
Infections and infestations   
URI   3/54 (5.56%) 
Injury, poisoning and procedural complications   
lip injury   2/54 (3.70%) 
Nervous system disorders   
headache   1/54 (1.85%) 
Skin and subcutaneous tissue disorders   
rash   1/54 (1.85%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: David Ginsberg, DO
Organization: Meda Pharmaceutical
Phone: 732 564 2200
Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01574612     History of Changes
Other Study ID Numbers: MP 800
First Submitted: April 5, 2012
First Posted: April 10, 2012
Results First Submitted: February 25, 2014
Results First Posted: May 22, 2014
Last Update Posted: May 22, 2014