Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Herpes Labialis | Drug: acyclovir/hydrocortisone cream | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | February 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: topical cream acyclovir/hydrocortisone
topical cream acyclovir/hydrocortisone used
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Drug: acyclovir/hydrocortisone cream
cream applied topically to lesion five times daily for five days
Other Name: Xerese(r) |
- Reporting of Adverse Events [ Time Frame: day 1 to day 21 ]treatment period is for 5 days and follow up visits at 7days and 21 days after first dose

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Ages Eligible for Study: | 6 Years to 11 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574612
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 |
Study Director: | David Ginsburg, D.O. | Meda Pharma US |
Responsible Party: | Meda Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01574612 |
Other Study ID Numbers: |
MP 800 |
First Posted: | April 10, 2012 Key Record Dates |
Results First Posted: | May 22, 2014 |
Last Update Posted: | May 22, 2014 |
Last Verified: | April 2014 |
Xerese acyclovir hydrocortisone cream herpes labialis pediatric |
Herpes Labialis Herpes Simplex Herpesviridae Infections DNA Virus Infections Virus Diseases Skin Diseases, Viral Lip Diseases Mouth Diseases |
Stomatognathic Diseases Skin Diseases, Infectious Skin Diseases Acyclovir Hydrocortisone Anti-Inflammatory Agents Antiviral Agents Anti-Infective Agents |