Herpes LabialisPhase 2NCT00469300
Iontophoretic Application of Acyclovir Gel to Treat Cold Sores
A Phase 2 study testing Iontophoretic delivery of acyclovir in people with Herpes Labialis, run by Transport Pharmaceuticals at 13 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 sites where the herpes virus is replicating. Iontophoresis uses electric current to enhance delivery of drugs through the skin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- Iontophoretic delivery of acyclovir
- How many people
- 810 participants
- Where
- 13 sitesUnited States
- Study dates
- Apr 2007to Oct 2007
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject 18-75 years of age
- Female subjects must be using a medically acceptable form of birth control during the study.
- 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, a history of cardiac arrhythmias or conduction abnormalities.
- Any evidence of active malignancy or immunodeficient disease within the last 30 days. 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.
- Subject requires chronic use of immunomodifying drugs (e.g. systemic steroids) or topical steroids on or near the face; use of inhaled steroids does not exclude a subject from the study.
- Subject requires chronic use of anti-viral medication.
- History of allergic or adverse response to acyclovir, or any related anti-viral drug, or the gel base.
- In females of childbearing potential, a positive urine pregnancy test at time of screening.
Show all 21Show fewer
- Nursing mothers.
- Subjects with an implantable electronic device.
- Subject has any body piercing in or around the area ordinarily affected by cold sores.
- Subject is considered unreliable or unable to understand or follow the protocol directions or is unable to comprehend or satisfactorily assess a herpetic lesion as determined by Investigator or designee at screening.
- Subject has abnormal skin conditions (e.g. acne, eczema, psoriasis, albinism, or chronic vesiculobullous disorders) that occur in the area ordinarily affected by cold sores or has significant facial hair in the area of the cold sore that might affect the normal course of the cold sore or might impair accurate evaluation of the cold sore lesion.
- Subject has had an infection with HSV-1 isolates know to be resistant to acyclovir, valacyclovir, famciclovir, or ganciclovir.
- Subject has had a herpes vaccine.
- Subject is currently enrolled in another clinical trial involving the use of a drug and/or a device.
- Subject has previously participated in the current study (TPI-H-221).
- Subject requires chronic use of analgesics, pain medication or non-steroidal anti-inflammatory agents (NSAIDs).
- Subject has a recent history of renal dysfunction or serious hepatic disease.
- Subject has a history of alcoholism or drug abuse within the preceding 12 months.
- Subject shares a household with another subject already enrolled in the study (TPI-H-221). If the other household member has already completed the study, then the currently enrolling subject is not excluded.
- Subject is institutionalized.
- Any history which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Radiant Research Birmingham
Birmingham, Alabama, 35209
Radiant Research Chicago
Chicago, Illinois, 60610
Radiant Research Cincinnati
Cincinnati, Ohio, 45236
Radiant Research Dallas North
Dallas, Texas, 75231
Radiant Research Minneapolis
Edina, Minnesota, 55435
Radiant Research Greer
Greer, South Carolina, 29651
Radiant Research Akron
Mogadore, Ohio, 44260
Radiant Research St. Petersburg
Pinellas Park, Florida, 33781
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Radiant Research San Antonio
San Antonio, Texas, 78229
Radiant Research Santa Rosa
Santa Rosa, California, 95405
Radiant Research St. Louis
St Louis, Missouri, 63141
OMEGA Medical Research
Warwick, Rhode Island, 02886
About this study
Official title: A Multicenter, Placebo Controlled, Randomized, Double Blind, Subject Initiated Study of the Safety and Efficacy of the Electrokinetic Transdermal System (ETS) With Acyclovir Gel for the Episodic Treatment of 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 sites where the herpes virus is replicating. Iontophoresis uses electric current to enhance delivery of drugs through the skin. This trial is testing a new iontophoretic device with a new acyclovir gel to treat cold sores.
Read the detailed description
This is a multicenter, placebo controlled, randomized, double blind, subject initiated study of the safety and efficacy of a single, 10-minute, topical iontophoretic application of a novel acyclovir 5% gel for the episodic treatment of recurrent herpes labialis. The design of the trial will also allow the comparison of the efficacy of a single iontophoretic treatment with acyclovir gel within 1 hour of first signs and/or symptoms of a herpetic episode to the efficacy of a single iontophoretic treatment with acyclovir gel 6 to18 hours after first signs and/or symptoms. Approximately 810 subjects will be enrolled to treat about 80 subjects in each of three treatment arms. Depending upon how the subject has been randomized into the trial, the subject will receive either: 1) an iontophoretic treatment with active gel within 1 hour of first signs/and or symptoms, followed 6-18 hours later by a second treatment with placebo gel; 2) an iontophoretic treatment with placebo gel within 1 hour of first signs/and or symptoms, followed 6-18 hours later by a second treatment with active gel; or 3) an iontophoretic treatment with placebo gel within 1 hour of first signs/and or symptoms, followed 6-18 hours later by a second treatment with placebo gel. 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 gel. At first signs and/or symptoms of a recurrent herpetic episode (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. The subject will then be instructed to return to the clinic within 6 to 18 hours of first signs and/or symptoms for a second iontophoretic treatment, appropriate to the treatment arm into which they have been randomized, and an evaluation. The subject will visit the clinic for daily follow-up evaluations for 3 to 14 days following the first treatment and will be called 2 weeks after their last clinic visit for a final safety evaluation.
- Conditions
- Herpes Labialis
- Being tested
- Iontophoretic delivery of 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 delivery of acyclovirDrug
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 the time of treatment until the lesion is healed.
Measured: Lesion assessments for a minimum of 3 consecutive days and a maximum of 14 days.
Secondary outcomes (1)
Clinician assessed: Prevention of progression to a classical lesion;Duration of classical herpetic lesions; Duration of herpetic lesions; Duration of the herpetic lesion hard scab; Duration until complete healing of the herpetic episode;
Measured: Lesion assessment for a minimum of 3 consecutive days and a maximum of 14 consecutive days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startApr 2007
- Primary completionSep 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 810 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transport Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eric M Morrel, PhD, Study director, Transport Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469300
- Sponsor's protocol ID
- TPI-H-221
- Status last verified
- Jan 2008
- First submitted
- 2 May 2007
- Last updated
- 4 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Morrel EM, Spruance SL, Goldberg DI; Iontophoretic Acyclovir Cold Sore Study Group. Topical iontophoretic administration of acyclovir for the episodic treatment of herpes labialis: a randomized, double-blind, placebo-controlled, clinic-initiated trial. Clin Infect Dis. 2006 Aug 15;43(4):460-7. doi: 10.1086/505872. Epub 2006 Jul 3.
PubMed 16838235
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2008. 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 the Electrokinetic Transdermal System (ETS) With Acyclovir Gel for the Episodic Treatment of Herpes Labialis
- ClinicalTrials.gov ID
- NCT00469300
- Acronym / sponsor ID
- TPI-H-221
- Conditions
- Herpes Labialis
- Keywords
- herpes labialis, cold sore, acyclovir, iontophoresis, topical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 810 participants (estimated)
- Lead sponsor
- Transport PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 4 May 2007 (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 sites where the herpes virus is replicating. Iontophoresis uses electric current to enhance delivery of drugs through the skin. This trial is testing a new iontophoretic device with a new acyclovir gel to treat cold sores.
Detailed description
This is a multicenter, placebo controlled, randomized, double blind, subject initiated study of the safety and efficacy of a single, 10-minute, topical iontophoretic application of a novel acyclovir 5% gel for the episodic treatment of recurrent herpes labialis. The design of the trial will also allow the comparison of the efficacy of a single iontophoretic treatment with acyclovir gel within 1 hour of first signs and/or symptoms of a herpetic episode to the efficacy of a single iontophoretic treatment with acyclovir gel 6 to18 hours after first signs and/or symptoms. Approximately 810 subjects will be enrolled to treat about 80 subjects in each of three treatment arms. Depending upon how the subject has been randomized into the trial, the subject will receive either: 1) an iontophoretic treatment with active gel within 1 hour of first signs/and or symptoms, followed 6-18 hours later by a second treatment with placebo gel; 2) an iontophoretic treatment with placebo gel within 1 hour of first signs/and or symptoms, followed 6-18 hours later by a second treatment with active gel; or 3) an iontophoretic treatment with placebo gel within 1 hour of first signs/and or symptoms, followed 6-18 hours later by a second treatment with placebo gel. 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 gel. At first signs and/or symptoms of a recurrent herpetic episode (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. The subject will then be instructed to return to the clinic within 6 to 18 hours of first signs and/or symptoms for a second iontophoretic treatment, appropriate to the treatment arm into which they have been randomized, and an evaluation. The subject will visit the clinic for daily follow-up evaluations for 3 to 14 days following the first treatment and will be called 2 weeks after their last clinic visit for a final safety evaluation.
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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subject 18-75 years of age
- Female subjects must be using a medically acceptable form of birth control during the study.
- 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 (21 listed)
- Subjects with a pacemaker, a history of cardiac arrhythmias or conduction abnormalities.
- Any evidence of active malignancy or immunodeficient disease within the last 30 days. 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.
- Subject requires chronic use of immunomodifying drugs (e.g. systemic steroids) or topical steroids on or near the face; use of inhaled steroids does not exclude a subject from the study.
- Subject requires chronic use of anti-viral medication.
- History of allergic or adverse response to acyclovir, or any related anti-viral drug, or the gel base.
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 delivery of acyclovir | Drug | – |
Primary outcome
Clinician assessed duration of the herpetic episode measured from the time of treatment until the lesion is healed.
Time frame: Lesion assessments for a minimum of 3 consecutive days and a maximum of 14 days.
1 secondary outcome
Clinician assessed: Prevention of progression to a classical lesion;Duration of classical herpetic lesions; Duration of herpetic lesions; Duration of the herpetic lesion hard scab; Duration until complete healing of the herpetic episode;
Time frame: Lesion assessment for a minimum of 3 consecutive days and a maximum of 14 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 Feb 2008.
- Background: PubMed 16838235Morrel EM, Spruance SL, Goldberg DI; Iontophoretic Acyclovir Cold Sore Study Group. Topical iontophoretic administration of acyclovir for the episodic treatment of herpes labialis: a randomized, double-blind, placebo-controlled, clinic-initiated trial. Clin Infect Dis. 2006 Aug 15;43(4):460-7. doi: 10.1086/505872. Epub 2006 Jul 3.
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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.
Eric M Morrel, PhD study director
Transport Pharmaceuticals, Inc.
13 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 delivery of acyclovir in people with Herpes Labialis, run by Transport Pharmaceuticals at 13 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 21 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 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 the time of treatment until the lesion is healed. (time frame: Lesion assessments for a minimum of 3 consecutive days and a maximum of 14 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00469300, which also lists 1 linked publication.
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 Feb 2008.