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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01257074

Enrollment

Registered

2010-12-09

Start date

2012-02-29

Completion date

2012-10-31

Last updated

2013-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Labialis

Keywords

Herpes Simplex

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

Interventions

DRUGAcyclovir 50mg/g

Cream, dose 5 times daily during 5 days

DRUGPenciclovir 10mg/g

Cream, dose 5 times daily during 5 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Day 10

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026