Back to resultsNon-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis
Primary Purpose
Herpes Labialis
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Acyclovir 50mg/g
Penciclovir 10mg/g
Sponsored by
About this trial
This is an interventional treatment trial for Herpes Labialis focused on measuring Herpes Simplex
Eligibility Criteria
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.
Sites / Locations
- Flavia Addor
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Drug 1
Drug 2
Arm Description
Penciclovir 10mg/g
Acyclovir 50mg/g
Outcomes
Primary Outcome Measures
Efficacy will be evaluated by the proportion of subjects with non herpes labialis manifestation
Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.
Secondary Outcome Measures
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01257074
Brief Title
Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Labialis
Keywords
Herpes Simplex
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug 1
Arm Type
Experimental
Arm Description
Penciclovir 10mg/g
Arm Title
Drug 2
Arm Type
Active Comparator
Arm Description
Acyclovir 50mg/g
Intervention Type
Drug
Intervention Name(s)
Acyclovir 50mg/g
Intervention Description
Cream, dose 5 times daily during 5 days
Intervention Type
Drug
Intervention Name(s)
Penciclovir 10mg/g
Intervention Description
Cream, dose 5 times daily during 5 days
Primary Outcome Measure Information:
Title
Efficacy will be evaluated by the proportion of subjects with non herpes labialis manifestation
Description
Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.
Time Frame
Day 10
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
Day 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavia Addor, MD
Organizational Affiliation
Medcin Instituto da Pele Ltda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Flavia Addor
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis
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