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

NCT01257074 | Completed Phase 3

• 1 other identifier: PENEMS1010
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Labialis

Keywords

Herpes Simplex

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Day 10

Study Arms (2)

Drug 1

EXPERIMENTAL

Penciclovir 10mg/g

Drug: Penciclovir 10mg/g

Drug 2

ACTIVE COMPARATOR

Acyclovir 50mg/g

Drug: Acyclovir 50mg/g

Interventions

Acyclovir 50mg/g DRUG

Cream, dose 5 times daily during 5 days

Drug 2

Penciclovir 10mg/g DRUG

Cream, dose 5 times daily during 5 days

Drug 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy or risk of pregnancy.
• Lactation
• Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study.)
• Sunlight over exposure in the last 15 days.
• Any pathology or past medical condition that can interfere with this protocol.
• AINH use, hormonal anti-inflammatory, analgesic and immunosuppressive drugs (in the last 30 days and during the study);
• Patients with immunodeficiency and/or immunosuppressive disease;
• Sunlight exposure in the last 15 days;
• Hypersensitivity to components of the formula;
• Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

Flavia Addor

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Herpes Labialis; Herpes Simplex

Interventions

Acyclovir; penciclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Flavia Addor, MD

  Medcin Instituto da Pele Ltda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 9, 2010
• Study Start: February 1, 2012
• Primary Completion: March 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 4, 2013

Record last verified: 2013-03

Locations

BR (1)