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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

Sponsor
EMS (Industry)
Overall Status
Completed
CT.gov ID
NCT01257074
Collaborator
(none)
76
Enrollment
1
Location
2
Arms
8
Duration (Months)
9.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Acyclovir 50mg/g
  • Drug: Penciclovir 10mg/g
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, 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.
Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Efficacy will be evaluated by the proportion of subjects with non herpes labialis manifestation [Day 10]

    Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.

Secondary Outcome Measures

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Day 10]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Flavia Addor São Paulo Brazil

Sponsors and Collaborators

  • EMS

Investigators

  • Principal Investigator: Flavia Addor, MD, Medcin Instituto da Pele Ltda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EMS
ClinicalTrials.gov Identifier:
NCT01257074
Other Study ID Numbers:
  • PENEMS1010
First Posted:
Dec 9, 2010
Last Update Posted:
Mar 4, 2013
Last Verified:
Mar 1, 2013
Keywords provided by EMS
Herpes Simplex
Additional relevant MeSH terms:
Herpes Simplex
Herpes Labialis
Acyclovir
Penciclovir

Study Results

No Results Posted as of Mar 4, 2013