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

December 6, 2010
March 1, 2013
February 2012
March 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01257074 on ClinicalTrials.gov Archive Site
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Day 10 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis
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 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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Herpes Labialis
  • Drug: Acyclovir 50mg/g
    Cream, dose 5 times daily during 5 days
  • Drug: Penciclovir 10mg/g
    Cream, dose 5 times daily during 5 days
  • Experimental: Drug 1
    Penciclovir 10mg/g
    Intervention: Drug: Penciclovir 10mg/g
  • Active Comparator: Drug 2
    Acyclovir 50mg/g
    Intervention: Drug: Acyclovir 50mg/g
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
October 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01257074
PENEMS1010
No
EMS
EMS
Not Provided
Principal Investigator: Flavia Addor, MD Medcin Instituto da Pele Ltda
EMS
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP