Herpes LabialisPhase 3NCT01574612
Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old
A Phase 3 study testing acyclovir/hydrocortisone cream in people with Herpes Labialis, run by Meda Pharmaceuticals at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- acyclovir/hydrocortisone cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 10 sitesUnited States
- Study dates
- Mar 2012to Feb 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Provident Clincal Research
Addison, Illinois, 60101
Corsicana Medical Research,PNC
Corsicana, Texas, 75110
Clinical Partners LLC
Johnston, Rhode Island, 02919
Central Kentucky Research
Lexington, Kentucky, 40509
MCS Clinical Trials
Los Angeles, California, 90057
Sunshine Research Center
Opa-locka, Florida, 33054
National Clinical Research-Richmond,Inc.
Richmond, Virginia, 23294
Rochester Clinical Research
Rochester, New York, 14609
Altus Rsearch,INC
West Palm Beach, Florida, 33407
PGM Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103
About this study
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
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.
- Conditions
- Herpes Labialis
- Being tested
- acyclovir/hydrocortisone cream
- Keywords
- Xerese, acyclovir hydrocortisone cream, herpes labialis, pediatric
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acyclovir/hydrocortisone creamDrug
Also called Xerese(r)
cream applied topically to lesion five times daily for five days
| Study group | Role | What they receive |
|---|---|---|
| topical cream acyclovir/hydrocortisone | Experimental | topical cream acyclovir/hydrocortisone used Receives: Drug: acyclovir/hydrocortisone cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reporting of Adverse Events
treatment period is for 5 days and follow up visits at 7days and 21 days after first dose
Measured: day 1 to day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Herpes LabialisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Responsible party
- Sponsor
- Investigators
- David Ginsburg, D.O., Study director, Meda Pharma US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574612
- Sponsor's protocol ID
- MP 800
- Status last verified
- Apr 2014
- First submitted
- 5 Apr 2012
- Last updated
- 22 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01574612
- Acronym / sponsor ID
- MP 800
- Conditions
- Herpes Labialis
- Keywords
- Xerese, acyclovir hydrocortisone cream, herpes labialis, pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Meda PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Posted 22 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| topical cream acyclovir/hydrocortisone | Experimental | Drug: acyclovir/hydrocortisone creamtopical cream acyclovir/hydrocortisone used |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acyclovir/hydrocortisone creamAlso: Xerese(r)cream applied topically to lesion five times daily for five days | Drug | topical cream acyclovir/hydrocortisone |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Herpes Labialis
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ginsburg, D.O. study director
Meda Pharma US
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acyclovir/hydrocortisone cream in people with Herpes Labialis, run by Meda Pharmaceuticals at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reporting of Adverse Events (time frame: day 1 to day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2014.