- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01257074
Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis
March 1, 2013 updated by: EMS
A Randomized, Double-Blind, to Compare Non-inferiority Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis.
Herpes labialis is the most common recurrent manifestation of herpes simplex.
The purpose of this study is to check the non-inferiority efficacy and safety of penciclovir 10mg/g as treatment for Herpes Labialis in comparison to acyclovir 50mg/g.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Study design:
• Double blinded non-inferiority prospective parallel-group, intend to treat trial.
Study design:
- Experiment duration: 10 days
- 3 visits (days 1,5 and 10)
- Erythema, papule, vesicle, ulcer, crust and healed skin evaluation
- Adverse events evaluation
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
São Paulo, Brazil
- Flavia Addor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must be able to understand the study procedures agree to participate and give written consent.
- Patients with clinical diagnosis of recurrent herpes labialis and are in the prodromal period (stinging, itching, burning and erythema) at the onset of signs / symptoms in the last 12-24 hours;
- No history of reaction to topical products;
Exclusion Criteria:
- Pregnancy or risk of pregnancy.
- Lactation
- Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study.)
- Sunlight over exposure in the last 15 days.
- Any pathology or past medical condition that can interfere with this protocol.
- AINH use, hormonal anti-inflammatory, analgesic and immunosuppressive drugs (in the last 30 days and during the study);
- Patients with immunodeficiency and/or immunosuppressive disease;
- Sunlight exposure in the last 15 days;
- Hypersensitivity to components of the formula;
- Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Drug 1
Penciclovir 10mg/g
|
Cream, dose 5 times daily during 5 days
|
Active Comparator: Drug 2
Acyclovir 50mg/g
|
Cream, dose 5 times daily during 5 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy will be evaluated by the proportion of subjects with non herpes labialis manifestation
Time Frame: Day 10
|
Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.
|
Day 10
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Day 10
|
Day 10
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Flavia Addor, MD, Medcin Instituto da Pele Ltda
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
December 6, 2010
First Submitted That Met QC Criteria
December 8, 2010
First Posted (Estimate)
December 9, 2010
Study Record Updates
Last Update Posted (Estimate)
March 4, 2013
Last Update Submitted That Met QC Criteria
March 1, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PENEMS1010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Herpes Labialis
-
BayerActive, not recruitingRecurrent Herpes LabialisUnited States
-
Topical RemedyBenu BioPharma, LLCCompletedRecurrent Herpes LabialisUnited States
-
NanoBio CorporationCompletedRecurrent Herpes LabialisUnited States
-
Southern California University of Health SciencesCompletedHerpes SimplexUnited States
-
Leciel BonoRecruitingHSV-1 | Herpes Simplex Labialis | Virus | Herpes Simplex 1United States
-
Topical RemedyBenu BioPharma, LLC; Accelovance; Optimal ResearchCompletedRecurrent Herpes LabialisUnited States
-
University of ZurichDevirex AGCompleted
-
NovartisCompleted
-
Hadassah Medical OrganizationUnknownReccurent Herpes Labialis
-
Laboratoire Boreaderme Inc.Ecogene 21Unknown
Clinical Trials on Penciclovir 10mg/g
-
Children's Hospital of PhiladelphiaAuto Dealers Caring for Kids FoundationCompleted
-
NovartisCompleted
-
Hanmi Pharmaceutical Company LimitedCompletedPrimary HypercholesterolemiaKorea, Republic of
-
Dong-A ST Co., Ltd.Completed
-
Vigonvita Life SciencesCompletedErectile DysfunctionChina
-
Yokohama City UniversityRecruiting
-
International University of Health and WelfareTerminated
-
Eisai Inc.CompletedRenal ImpairmentUnited States
-
Eisai Inc.Completed
-
Alvogen KoreaCompletedPrimary HypercholesterolemiaKorea, Republic of