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

NCT ID: NCT01257074

Last Updated: 2013-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-10-31

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

Conditions

Herpes Labialis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Drug 1

Penciclovir 10mg/g

Group Type: EXPERIMENTAL

Penciclovir 10mg/g

Intervention Type: DRUG

Cream, dose 5 times daily during 5 days

Drug 2

Acyclovir 50mg/g

Group Type: ACTIVE_COMPARATOR

Acyclovir 50mg/g

Intervention Type: DRUG

Cream, dose 5 times daily during 5 days

Interventions

Acyclovir 50mg/g

Cream, dose 5 times daily during 5 days

Intervention Type: DRUG

Penciclovir 10mg/g

Cream, dose 5 times daily during 5 days

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Flavia Addor, MD

Role: PRINCIPAL_INVESTIGATOR

Medcin Instituto da Pele Ltda

Locations

Flavia Addor

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

PENEMS1010

Identifier Type: -

Identifier Source: org_study_id