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

Information source: Meda Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Labialis

Intervention: acyclovir/hydrocortisone cream (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Meda Pharmaceuticals

Official(s) and/or principal investigator(s):
David Ginsburg, D.O., Study Director, Affiliation: Meda Pharma US

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.

Clinical Details

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

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

Primary outcome: Reporting of Adverse Events

Eligibility

Minimum age: 6 Years. Maximum age: 11 Years. Gender(s): Both.

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)

Locations and Contacts

MCS Clinical Trials, Los Angeles, California 90057, United States

Sunshine Research Center, Opa-Locka, Florida 33054, United States

Altus Rsearch,INC, West Palm Beach, Florida 33407, United States

Provident Clincal Research, Addison, Illinois 60101, United States

Central Kentucky Research, Lexington, Kentucky 40509, United States

Rochester Clinical Research, Rochester, New York 14609, United States

PGM Research of Winston-Salem, LLC, Winston-Salem, North Carolina 27103, United States

Clinical Partners LLC, Johnston, Rhode Island 02919, United States

Corsicana Medical Research,PNC, Corsicana, Texas 75110, United States

National Clinical Research-Richmond,Inc., Richmond, Virginia 23294, United States

Additional Information

Starting date: March 2012
Last updated: April 28, 2014

Page last updated: August 23, 2015

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