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COMPLETED Phase 3

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

NCT01574612 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG acyclovir/hydrocortisone cream

Study Locations (10)

Florida

  • Sunshine Research Center — Opa-locka
  • Altus Rsearch,INC — West Palm Beach

California

  • MCS Clinical Trials — Los Angeles

Illinois

  • Provident Clincal Research — Addison

Kentucky

  • Central Kentucky Research — Lexington

New York

  • Rochester Clinical Research — Rochester

North Carolina

  • PGM Research of Winston-Salem, LLC — Winston-Salem

Rhode Island

  • Clinical Partners LLC — Johnston

Texas

  • Corsicana Medical Research,PNC — Corsicana

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2012-03
Est. Completion 2013-02
Phase Phase 3

Sponsor

Meda Pharmaceuticals

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01574612

The ClinicalTrials.gov registry entry for NCT01574612 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Meda Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Herpes Labialis appearing as the primary indexed condition, and to 1 intervention — of which acyclovir/hydrocortisone cream is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01574612 reports 10 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01574612 about?

NCT01574612 is a clinical study titled "Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old". 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.

What is the current status of trial NCT01574612?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 54 participants. The study started on 2012-03. Estimated completion is 2013-02.

What conditions does trial NCT01574612 study?

This clinical trial studies the following conditions: Herpes Labialis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01574612?

The interventions under investigation include: acyclovir/hydrocortisone cream (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01574612?

This trial is sponsored by Meda Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01574612 being conducted?

This trial has 10 study locations across California, Florida, Illinois, Kentucky, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial