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

This study has been completed.
Sponsor:
Collaborator:
TKL Research, Inc.
Information provided by (Responsible Party):
Meda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01574612
First received: April 5, 2012
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Herpes Labialis
Drug: acyclovir/hydrocortisone cream
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Meda Pharmaceuticals:

Primary Outcome Measures:
  • Reporting of Adverse Events [ Time Frame: day 1 to day 21 ] [ Designated as safety issue: Yes ]
    treatment period is for 5 days and follow up visits at 7days and 21 days after first dose


Enrollment: 54
Study Start Date: March 2012
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: topical cream acyclovir/hydrocortisone
topical cream acyclovir/hydrocortisone used
Drug: acyclovir/hydrocortisone cream
cream applied topically to lesion five times daily for five days
Other Name: Xerese(r)

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574612

Locations
United States, California
MCS Clinical Trials
Los Angeles, California, United States, 90057
United States, Florida
Sunshine Research Center
Opa-Locka, Florida, United States, 33054
Altus Rsearch,INC
West Palm Beach, Florida, United States, 33407
United States, Illinois
Provident Clincal Research
Addison, Illinois, United States, 60101
United States, Kentucky
Central Kentucky Research
Lexington, Kentucky, United States, 40509
United States, New York
Rochester Clinical Research
Rochester, New York, United States, 14609
United States, North Carolina
PGM Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States, 27103
United States, Rhode Island
Clinical Partners LLC
Johnston, Rhode Island, United States, 02919
United States, Texas
Corsicana Medical Research,PNC
Corsicana, Texas, United States, 75110
United States, Virginia
National Clinical Research-Richmond,Inc.
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Meda Pharmaceuticals
TKL Research, Inc.
Investigators
Study Director: David Ginsburg, D.O. Meda Pharma US
  More Information

No publications provided

Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01574612     History of Changes
Other Study ID Numbers: MP 800
Study First Received: April 5, 2012
Results First Received: February 25, 2014
Last Updated: April 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Meda Pharmaceuticals:
Xerese
acyclovir hydrocortisone cream
herpes labialis
pediatric

Additional relevant MeSH terms:
Herpes Labialis
DNA Virus Infections
Herpes Simplex
Herpesviridae Infections
Lip Diseases
Mouth Diseases
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Viral
Stomatognathic Diseases
Virus Diseases
Acyclovir
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Anti-Infective Agents
Anti-Inflammatory Agents
Antiviral Agents
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014