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Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01257074
First received: December 6, 2010
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Herpes Labialis
 Drug: Acyclovir 50mg/g
Drug: Penciclovir 10mg/g
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by EMS:

Primary Outcome Measures:
  • Efficacy will be evaluated by the proportion of subjects with non herpes labialis manifestation [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 10 ] [ Designated as safety issue: Yes ]

Enrollment: 76
Study Start Date: February 2012
Study Completion Date: October 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug 1
Penciclovir 10mg/g
 Drug: Penciclovir 10mg/g
Cream, dose 5 times daily during 5 days
Active Comparator: Drug 2
Acyclovir 50mg/g
 Drug: Acyclovir 50mg/g
Cream, dose 5 times daily during 5 days

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must be able to understand the study procedures agree to participate and give written consent.
  2. 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;
  3. No history of reaction to topical products;

Exclusion Criteria:

  1. Pregnancy or risk of pregnancy.
  2. Lactation
  3. Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study.)
  4. Sunlight over exposure in the last 15 days.
  5. Any pathology or past medical condition that can interfere with this protocol.
  6. AINH use, hormonal anti-inflammatory, analgesic and immunosuppressive drugs (in the last 30 days and during the study);
  7. Patients with immunodeficiency and/or immunosuppressive disease;
  8. Sunlight exposure in the last 15 days;
  9. Hypersensitivity to components of the formula;
  10. Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257074

Locations
Brazil
Flavia Addor
São Paulo, Brazil
Sponsors and Collaborators
EMS
Investigators
Principal Investigator: Flavia Addor, MD Medcin Instituto da Pele Ltda
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01257074     History of Changes
Other Study ID Numbers: PENEMS1010
Study First Received: December 6, 2010
Last Updated: March 1, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by EMS:
Herpes Simplex

Additional relevant MeSH terms:
Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
 Skin Diseases, Infectious
Skin Diseases
Acyclovir
Penciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013