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

Herpes Labialis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257074
• Other study ID #: PENEMS1010
• Status: Completed
• Phase: Phase 3
• First received: December 6, 2010
• Last updated: March 1, 2013
• Start date: February 2012
• Est. completion date: October 2012

Study information

• Verified date: March 2013
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Herpes Labialis

Intervention

Drug:
• Acyclovir 50mg/g
Cream, dose 5 times daily during 5 days
• Penciclovir 10mg/g
Cream, dose 5 times daily during 5 days

Locations

Country	Name	City	State
Brazil	Flavia Addor	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy will be evaluated by the proportion of subjects with non herpes labialis manifestation	Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.	Day 10	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Day 10	Yes