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Trial record 68 of 112 for:    acyclovir

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02265913
Recruitment Status : Completed
First Posted : October 16, 2014
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Perrigo Company

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.

Condition or disease Intervention/treatment Phase
Herpes Labialis Drug: Acyclovir 5 percent (Perrigo) Drug: Acyclovir 5 percent (Reference) Drug: Placebo cream Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4076 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2014
Actual Primary Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cold Sores

Arm Intervention/treatment
Experimental: Test Product
acyclovir cream
Drug: Acyclovir 5 percent (Perrigo)
Other Name: Perrigo product

Active Comparator: Reference Product
acyclovir cream
Drug: Acyclovir 5 percent (Reference)
Other Name: Reference Listed Drug Product

Placebo Comparator: Placebo Product
Placebo cream
Drug: Placebo cream



Primary Outcome Measures :
  1. Lesion healing [ Time Frame: up to 21 days ]
    Time to complete healing of lesions measured in days from the time of first dosing



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provides written informed consent/assent
  2. Immunocompetent male or non-pregnant females, >12 years old, with limited, non-life-threatening, recurrent herpes simplex labialis.
  3. Subjects must have at least 3 recurrences of herpes simplex labialis per year for the past two years.
  4. Females of childbearing potential willing to use an acceptable form of birth control.
  5. 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.
  6. Subjects must be willing and able to understand and comply with the requirements of the study.

Exclusion Criteria:

  1. 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.
  2. The use of antiviral therapies in various forms for a given period of time prior to screening and study medication application.
  3. Candidate for or previous use of parenteral antiviral treatment or prophylactic antiviral therapy for their recurrent herpes simplex labialis.
  4. Recently received an organ transplant.
  5. Subjects who are immunocompromised, HIV positive or who have any immune-system disorders.
  6. 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.
  7. Subjects with known or suspected history of a clinically significant systemic disease, unstable medical disorders, life-threatening disease or current malignancies.
  8. Subjects with a current episode of herpes simplex labialis that has not completely healed.
  9. Presence of any facial skin condition or excessive facial hair that may interfere with diagnosis, assessment, and/or healing ability.
  10. History of herpes keratitis.
  11. Subject has a history of hypersensitivity or allergy to any ingredient in the drug product.
  12. History of unresponsiveness to topical acyclovir therapy.
  13. Participation in any other clinical study or who have received treatment with any investigational drug or device within 30 days prior to screening.
  14. Subjects who have previously enrolled in this study.
  15. 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).
  16. Subjects who have been treated with immunosuppressive medication therapy within 8 weeks prior to the study both enrollment/screening and Day 1 (Visit 2).
  17. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements in the investigator's opinion.
  18. Use of tanning booths, sun lamps, or excessive exposure to the sun for up to 21 days from initiating study medication
  19. Subjects using immunostimulators, dye-light therapy, or psoralen therapy within 30 days prior to study medication initiation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02265913


Locations
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United States, Nebraska
Quality Clinical Research Inc
Omaha, Nebraska, United States, 68114
Sponsors and Collaborators
Perrigo Company

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Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT02265913     History of Changes
Other Study ID Numbers: PRG-NY-14-008
First Posted: October 16, 2014    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
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Acyclovir
Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases
Antiviral Agents
Anti-Infective Agents