Herpes LabialisPhase 2NCT00230867
Iontophoretic Application of Acyclovir Cream to Treat Recurrent Herpes Labialis
A Phase 2 study testing iontophoretic acyclovir in people with Herpes Labialis, run by Transport Pharmaceuticals at 26 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- iontophoretic acyclovir
- Type of treatment
- Medical device
- How many people
- 1,800 participants
- Where
- 26 sitesUnited States
- Study dates
- Apr 2005to Dec 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subject 18-75 years of age
- 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.
- Subject must have a history of recurrent herpes labialis and report at least 3 recurrences during the preceding 12 months.
- Subject must provide voluntary written informed consent to participate in this study.
Who cannot join
- 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.
- 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.
- 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.
- History of allergic or adverse response to acyclovir, or any related anti-viral drug, or the cream base.
- In females of childbearing potential, a positive urine pregnancy test at time of screening.
- 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.
Show all 14Show fewer
- 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).
- Subject is currently enrolled in another clinical trial or has used an investigational drug/device within 30 days of enrollment.
- Subject has previously participated in the current study (TPI-203).
- Subject has used an anti-viral medication in the preceding 30 days.
- 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.
- 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.
- 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.
- Subject is institutionalized.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Radiant Research Atlanta West
Atlanta, Georgia, 30308
Radiant Research Atlanta
Atlanta, Georgia, 30342
Dermatology & Laser Center NW
Bellingham, Washington, 98225
Radiant Research Birmingham
Birmingham, Alabama, 35209
Radiant Research Boise
Boise, Idaho, 83704
J & S Studies, Inc.
Bryan, Texas, 77802
Radiant Research Phoenix Southeast
Chandler, Arizona, 85225
Radiant Research Chicago
Chicago, Illinois, 60610
Radiant Research Cincinnati
Cincinnati, Ohio, 45236
Pediatric Clinical Trials International
Columbus, Ohio, 43205
Radiant Research Dallas North
Dallas, Texas, 75231
Radiant Research Minneapolis
Edina, Minnesota, 55435
Radiant Research Greer
Greer, South Carolina, 29651
Radiant Research Tacoma
Lakewood, Washington, 98499
Radiant Research Philadelphia
Philadelphia, Pennsylvania, 19115
Radiant Research Phoenix
Phoenix, Arizona, 85013
Radiant Research St. Petersburg
Pinellas Park, Florida, 33781
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Univeristy of Utah Health Sciences
Salt Lake City, Utah, 84132
Radiant Research San Antonio
San Antonio, Texas, 78229
Radiant Research San Diego
San Diego, California, 92123
Radiant Research Santa Rosa
Santa Rosa, California, 95405
Radiant Research Scottsdale
Scottsdale, Arizona, 85251
Radiant Research St. Louis
St Louis, Missouri, 63141
Radiant Research Stuart
Stuart, Florida, 34996
Radiant Research West Palm
West Palm Beach, Florida, 33407
About this study
Official title: A Multicenter, Placebo Controlled, Randomized, Double Blind, Subject Initiated Study of the Safety and Efficacy of a Single Topical Iontophoretic Application of Acyclovir 5% Cream With an Open Label Conventional Therapy Treatment Arm, and a Blinded Evaluator, for the Treatment of Recurrent Herpes Labialis
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.
Read the 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
- Being tested
- iontophoretic acyclovir
- Keywords
- herpes labialis, cold sore, acyclovir, iontophoresis, topical
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iontophoretic acyclovirDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician assessed duration of the herpetic episode measured from time of treatment until lesion healed. Lesion assessments for a minimum of 5 consecutive days and a maximum of 10 consecutive days.
Secondary outcomes (6)
Clinician assessed prevention of progression to a classical lesion
Clinician assessed duration of classical herpetic lesions.
Clinician assessed duration of the herpetic lesion (aborted lesions will be assigned a duration of lesion value of 0 for the purposes of the statistical analysis).
Clinician assessed duration of the herpetic lesion hard scab.
Examine the safety of iontophoretic application of acyclovir 5% cream.
All assessments for a minimum of 5 consecutive days and a maximum of 10 consecutive days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2005 (estimated)
- Study startApr 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes LabialisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,800 participants
Sponsor and investigators
- Lead sponsor
- Transport Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christopher M Hull, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230867
- Sponsor's protocol ID
- TPI-203
- Status last verified
- Jun 2006
- First submitted
- 29 Sep 2005
- Last updated
- 4 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Placebo Controlled, Randomized, Double Blind, Subject Initiated Study of the Safety and Efficacy of a Single Topical Iontophoretic Application of Acyclovir 5% Cream With an Open Label Conventional Therapy Treatment Arm, and a Blinded Evaluator, for the Treatment of Recurrent Herpes Labialis
- ClinicalTrials.gov ID
- NCT00230867
- Acronym / sponsor ID
- TPI-203
- Conditions
- Herpes Labialis
- Keywords
- herpes labialis, cold sore, acyclovir, iontophoresis, topical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants
- Lead sponsor
- Transport PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Dec 2005
- First posted
- 3 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subject 18-75 years of age
- 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.
- Subject must have a history of recurrent herpes labialis and report at least 3 recurrences during the preceding 12 months.
- Subject must provide voluntary written informed consent to participate in this study.
Key exclusion criteria (14 listed)
- 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.
- 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.
- 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.
- History of allergic or adverse response to acyclovir, or any related anti-viral drug, or the cream base.
- In females of childbearing potential, a positive urine pregnancy test at time of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iontophoretic acyclovir | Device | – |
Primary outcome
Clinician assessed duration of the herpetic episode measured from time of treatment until lesion healed. Lesion assessments for a minimum of 5 consecutive days and a maximum of 10 consecutive days.
6 secondary outcomes
Clinician assessed prevention of progression to a classical lesion
Clinician assessed duration of classical herpetic lesions.
Clinician assessed duration of the herpetic lesion (aborted lesions will be assigned a duration of lesion value of 0 for the purposes of the statistical analysis).
Clinician assessed duration of the herpetic lesion hard scab.
Examine the safety of iontophoretic application of acyclovir 5% cream.
All assessments for a minimum of 5 consecutive days and a maximum of 10 consecutive days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2006.
- Sponsor company websiteLink provided by the sponsor.
Related trials for Herpes Labialis
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher M Hull, MD principal investigator
University of Utah
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing iontophoretic acyclovir in people with Herpes Labialis, run by Transport Pharmaceuticals at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician assessed duration of the herpetic episode measured from time of treatment until lesion healed. Lesion assessments for a minimum of 5 consecutive days and a maximum of 10 consecutive days.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2006.