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

Meda Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Herpes Labialis

Treatments

Drug: acyclovir/hydrocortisone cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT01574612

MP 800

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

6 to 11 years old

Volunteers

No Healthy Volunteers

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)