Iontophoretic Application of Acyclovir Cream to Treat Recurrent Herpes Labialis

NCT ID: NCT00230867

Last Updated: 2006-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2005-12-31

Brief Summary

Currently approved drugs for the treatment of herpes labialis (cold sores) exhibit low levels of efficacy due to the limited ability of the drugs to penetrate the skin to the site where the herpes virus is replicating. Iontophoresis uses electric current to enhance the delivery of drugs through the skin. This trial is testing a new iontophoretic device for the delivery of acyclovir cream to treat cold sores.

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of iontophoretically-applied acyclovir 5% cream for the treatment of herpes simplex labialis lesions including an open label arm using Zovirax (acyclovir) Cream 5% as per standard of care in the same patient population. Subjects who meet the eligibility requirements at the screening/randomization visit will be randomized in a 1:1:1 ratio to one of the three treatment groups. After being enrolled and randomized into the study, subjects will be sent home with a locked kit containing the iontophoretic device with either active or placebo cream or a locked kit containing Zovirax Cream 5%. At first signs and/or symptoms of a recurrent herpetic episode (Stage 0 or 1, prodromal or erythema), the lesion will be confirmed by telephone interview with the subject, and upon confirmation of the lesion, the subject will be given the combination to the locked kit and instructed to begin treatment immediately, thereby initiating the Treatment Phase of the study. Subjects will be followed for at least 5 consecutive days post-treatment up until a maximum of 10 consecutive days post-treatment, until the herpes lesion is healed.

Conditions

Herpes Labialis

Keywords

herpes labialis; cold sore; acyclovir; iontophoresis; topical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

iontophoretic acyclovir

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female subject 18-75 years of age

2. Female subject must be using a medically acceptable form of birth control during the study. Acceptable birth control measures are abstinence, oral contraceptive pills or patch, injectable contraception, barrier contraceptives (condom, diaphragm with spermicide), IUD, surgical (hysterectomy, tubal ligation), vasectomized partner, or natural post menopausal inability to conceive.

3. Subject must have a history of recurrent herpes labialis and report at least 3 recurrences during the preceding 12 months.

4. Subject must provide voluntary written informed consent to participate in this study.

Exclusion Criteria

1. Subjects with a pacemaker, or a history of cardiac arrhythmias or conduction abnormalities. Any subject with a medically confirmed history of cardiac arrhythmia including sinus arrhythmia, premature beat, heart block, atrial fibrillation, atrial flutter and pulsus alternans is to be excluded from the study.

2. Any evidence of active malignancy, immunodeficient disease, or use of immunomodifying drugs (e.g., systemic steroids) within 30 days prior to enrollment. Subjects who have completed therapy and are considered unlikely to relapse or who have had surgery and do not have any evidence of disease, are eligible for the study.

3. Subjects using topical steroids on or near the face or systemic (oral, intravenous) steroids within 30 days of enrollment; use of inhaled steroids does not exclude a subject from the study.

4. History of allergic or adverse response to acyclovir, or any related anti-viral drug, or the cream base.

5. In females of childbearing potential, a positive urine pregnancy test at time of screening.

6. Subject is considered unreliable or unable to understand or follow the protocol directions or is unable to comprehend or satisfactorily use the measurement scales as determined by investigator or designee at screening.

7. Subject has abnormal skin conditions that occur in the area ordinarily affected by cold sores which might affect the normal course of cold sores (e.g., eczema, psoriasis, albinism, or chronic vesiculobullous disorders).

8. Subject is currently enrolled in another clinical trial or has used an investigational drug/device within 30 days of enrollment.

9. Subject has previously participated in the current study (TPI-203).

10. Subject has used an anti-viral medication in the preceding 30 days.

11. Subject requires chronic use of analgesics, pain medication or non-steroidal anti-inflammatory agents (NSAIDs). If a subject is unlikely to get through the treatment phase of the protocol without requiring the use of analgesia for a chronic condition, e.g. back pain, recurrent daily headaches, the subject should be excluded.

12. Subject has a recent history of renal dysfunction or serious hepatic disease. Renal dysfunction encompasses both acute and chronic renal failure, the former resulting from the sudden loss of the ability of the kidneys to excrete wastes, concentrate urine, and conserve electrolytes and the latter the gradual and progressive loss of these capabilities. Examples of serious hepatic disease would include alcoholic liver disease, chronic hepatitis, autoimmune hepatitis and a variety of inherited diseases. The underlying cause of a documented recent mild increase in liver enzymes should be considered when deciding whether or not to exclude such a subject.

13. Subject has a history of alcoholism or drug abuse within the preceding 12 months. A subject with a history of a pathological pattern of alcohol use that causes a serious impairment of social or occupational functioning should be excluded. Such subjects may exhibit symptoms of tolerance and withdrawal along with other behavioral symptoms.

14. Subject is institutionalized.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Transport Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Christopher M Hull, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Radiant Research Birmingham

Birmingham, Alabama, United States

Radiant Research Phoenix Southeast

Chandler, Arizona, United States

Radiant Research Phoenix

Phoenix, Arizona, United States

Radiant Research Scottsdale

Scottsdale, Arizona, United States

Radiant Research San Diego

San Diego, California, United States

Radiant Research Santa Rosa

Santa Rosa, California, United States

Radiant Research St. Petersburg

Pinellas Park, Florida, United States

Radiant Research Stuart

Stuart, Florida, United States

Radiant Research West Palm

West Palm Beach, Florida, United States

Radiant Research Atlanta West

Atlanta, Georgia, United States

Radiant Research Atlanta

Atlanta, Georgia, United States

Radiant Research Boise

Boise, Idaho, United States

Radiant Research Chicago

Chicago, Illinois, United States

Radiant Research Minneapolis

Edina, Minnesota, United States

Radiant Research St. Louis

St Louis, Missouri, United States

Rochester Clinical Research, Inc.

Rochester, New York, United States

Radiant Research Cincinnati

Cincinnati, Ohio, United States

Pediatric Clinical Trials International

Columbus, Ohio, United States

Radiant Research Philadelphia

Philadelphia, Pennsylvania, United States

Radiant Research Greer

Greer, South Carolina, United States

J & S Studies, Inc.

Bryan, Texas, United States

Radiant Research Dallas North

Dallas, Texas, United States

Radiant Research San Antonio

San Antonio, Texas, United States

Univeristy of Utah Health Sciences

Salt Lake City, Utah, United States

Dermatology & Laser Center NW

Bellingham, Washington, United States

Radiant Research Tacoma

Lakewood, Washington, United States

Countries

United States

Related Links

http://www.transportpharma.com

Sponsor company website

Other Identifiers

TPI-203

Identifier Type: -

Identifier Source: org_study_id