Herpes Labialis
Conditions
Keywords
Xerese, acyclovir hydrocortisone cream, herpes labialis, pediatric
Brief 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.
Interventions
DRUGacyclovir/hydrocortisone cream
cream applied topically to lesion five times daily for five days
Sponsors
TKL Research, Inc.
Meda Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reporting of Adverse Events | day 1 to day 21 | treatment period is for 5 days and follow up visits at 7days and 21 days after first dose |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Topical Cream xerese topical cream is the only active used in this trial | 54 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | non compliant with drug | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Topical Cream |
|---|---|
| Age, Categorical <=18 years | 54 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 9.1 years STANDARD_DEVIATION 1.7 |
| age of subjects with prior history of herpes labialis outbreak age 4 to 6 years | 17 participants 21.5 |
| age of subjects with prior history of herpes labialis outbreak age 7 to 9 years | 10 participants 13.9 |
| age of subjects with prior history of herpes labialis outbreak less than or equal to 3 years | 27 participants 33 |
| Region of Enrollment United States | 54 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 54 |
| serious Total, serious adverse events | 0 / 54 |
Outcome results
Primary
Reporting of Adverse Events
treatment period is for 5 days and follow up visits at 7days and 21 days after first dose
Time frame: day 1 to day 21
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topical Cream | Reporting of Adverse Events | 9 participants |