Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis

NCT02265913 | Completed Phase 3 Results

• 1 other identifier: PRG-NY-14-008
• Study Type: interventional
• Target: 4,076
• Locations: 1 country
• Sites: 1

Brief Summary

To compare safety and efficacy of Perrigo's antiviral drug product compared to an FDA approved antiviral drug product in the treatment of cold sores.

Conditions

Herpes Labialis

Outcome Measures

Primary Outcomes (1)

• Lesion Healing

  Time to complete healing of lesions measured in hours from the time of first dosing

  up to 21 days

Study Arms (3)

Test Product

EXPERIMENTAL

acyclovir cream

Drug: Acyclovir 5 percent (Perrigo)

Reference Product

ACTIVE COMPARATOR

acyclovir cream

Drug: Acyclovir 5 percent (Reference)

Placebo Product

PLACEBO COMPARATOR

Placebo cream

Drug: Placebo cream

Interventions

Acyclovir 5 percent (Perrigo) DRUG

Also known as: Perrigo product

Test Product

Acyclovir 5 percent (Reference) DRUG

Also known as: Reference Listed Drug Product

Reference Product

Placebo cream DRUG

Placebo Product

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provides written informed consent/assent
• Immunocompetent male or non-pregnant females, \>12 years old, with limited, non-life-threatening, recurrent herpes simplex labialis.
• Subjects must have at least 3 recurrences of herpes simplex labialis per year for the past two years.
• Females of childbearing potential willing to use an acceptable form of birth control.
• Subjects must be in general good health with no clinically significant disease that might interfere with the study evaluations in the opinion of the investigator.
• Subjects must be willing and able to understand and comply with the requirements of the study.

You may not qualify if:

• Females who are pregnant or nursing, are not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study.
• The use of antiviral therapies in various forms for a given period of time prior to screening and study medication application.
• Candidate for or previous use of parenteral antiviral treatment or prophylactic antiviral therapy for their recurrent herpes simplex labialis.
• Recently received an organ transplant.
• Subjects who are immunocompromised, HIV positive or who have any immune-system disorders.
• Recent major change in immune system status that could seriously affect the clinical manifestations of herpes simplex labialis and need for treatment in the opinion of the investigator.
• Subjects with known or suspected history of a clinically significant systemic disease, unstable medical disorders, life-threatening disease or current malignancies.
• Subjects with a current episode of herpes simplex labialis that has not completely healed.
• Presence of any facial skin condition or excessive facial hair that may interfere with diagnosis, assessment, and/or healing ability.
• History of herpes keratitis.
• Subject has a history of hypersensitivity or allergy to any ingredient in the drug product.
• History of unresponsiveness to topical acyclovir therapy.
• Participation in any other clinical study or who have received treatment with any investigational drug or device within 30 days prior to screening.
• Subjects who have previously enrolled in this study.
• Subjects who have received any local medication in the target area during the 2 weeks prior to both enrollment/screening and Day 1 (Visit 2).

Sponsors & Collaborators

• Padagis LLC: lead

Study Sites (1)

Quality Clinical Research Inc

Omaha, Nebraska, 68114, United States

Location

MeSH Terms

Conditions

Herpes Labialis

Condition Hierarchy (Ancestors)

Herpes Simplex; 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

Results Point of Contact

• Title: Jonathan Schwartz
• Organization: Perrigo

jonathan.schwartz@perrigo.com

718-960-9900

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 16, 2014
• Study Start: October 6, 2014
• Primary Completion: April 27, 2016
• Study Completion: November 21, 2017
• Last Updated: October 22, 2021
• Results First Posted: January 5, 2021

Record last verified: 2021-10

Locations

US (1)