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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
Information provided by (Responsible Party):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Topical Cream

commercial product being used

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

Participant Flow:   Overall Study
    Topical Cream
STARTED   54 [1] 
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

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Topical Cream xerese topical cream is the only active used in this trial

Baseline Measures
   Topical Cream 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 9.1  (1.7) 
[Units: Participants]
<=18 years   54 
Between 18 and 65 years   0 
>=65 years   0 
[Units: Participants]
Female   31 
Male   23 
Region of Enrollment 
[Units: Participants]
United States   54 
age of subjects with prior history of herpes labialis outbreak 
[Units: Participants]
less than or equal to 3 years   27 
age 4 to 6 years   17 
age 7 to 9 years   10 

  Outcome Measures

1.  Primary:   Reporting of Adverse Events   [ Time Frame: day 1 to day 21 ]

  Serious Adverse Events

  Other Adverse Events

  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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  More Information

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
e-mail: ginsberg.david@gmail.com

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