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

Herpes Labialis Clinical Trial

Official title:

An Open Label Multi Center Phase III Subject/Caregiver Initiated Safety Study of Xerese(Acyclovir and Hydrocortisone)Cream 5%/1% in the Treatment of Recurrent Herpes Labialis in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574612
• Other study ID #: MP 800
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2012
• Last updated: April 28, 2014
• Start date: March 2012
• Est. completion date: February 2013

Study information

• Verified date: April 2014
• Source: Meda Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To test the safety of Xerese (acyclovir and hydrocortisone)Cream 5%/1% for the treatment of recurrent cold sores in children ages 6-11yrs after 5 days of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

Inclusion Criteria:

• Male or female, age 6-11 years at time of enrollment

• General good health, as judged by the Investigator

• History of recurrent herpes labialis with at least two (2) recurrences during the last twelve (12) months, as based on interview with the subject or subject's caregiver

• Agreement to refrain from using other topical medical, over-the counter (OTC), or cosmetic products in or around the oral area during the herpes recurrence

• Agreement to refrain from mechanical disruption of the area affected by herpes labialis during the study recurrence

• Subjects and their legally acceptable representative(s) must voluntarily sign and date the informed assent (subject) and consent (legally authorized representative).

• Willingness to comply with all requirements of the study.

Exclusion Criteria:

• Any evidence of an immunosuppressed state of the subject due to underlying disease (e.g. HIV infection) or concomitant treatment (e.g. cancer chemotherapy)

• Significant skin conditions that occur in the area typically affected by herpes recurrences, and that would interfere with assessment of lesions such as atopic dermatitis, acne, eczema, psoriasis or chronic vesiculobullous disorders

• Administration of an investigational drug or within 30 days prior to inclusion, or concurrent participation in another research study

• Administration of an immunomodulatory agent within the past 30 days

• History of immediate hypersensitivity or serum sickness reaction to any nucleoside analog antiviral agent, or to any topical steroid, or to the vehicle

• Clinically relevant abnormal physical findings at screening which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures Nursing or pregnant (Pubescent females require pregnancy testing)

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Labialis

Intervention

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

Locations

Country	Name	City	State
United States	Provident Clincal Research	Addison	Illinois
United States	Corsicana Medical Research,PNC	Corsicana	Texas
United States	Clinical Partners LLC	Johnston	Rhode Island
United States	Central Kentucky Research	Lexington	Kentucky
United States	MCS Clinical Trials	Los Angeles	California
United States	Sunshine Research Center	Opa-Locka	Florida
United States	National Clinical Research-Richmond,Inc.	Richmond	Virginia
United States	Rochester Clinical Research	Rochester	New York
United States	Altus Rsearch,INC	West Palm Beach	Florida
United States	PGM Research of Winston-Salem, LLC	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Meda Pharmaceuticals	TKL Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reporting of Adverse Events	treatment period is for 5 days and follow up visits at 7days and 21 days after first dose	day 1 to day 21	Yes