Herpes LabialisPhase 2NCT00453401
Safety, Pharmacokinetics, and Efficacy Study of NB-001 to Treat Recurrent Herpes Labialis
A Phase 2 study testing NB-001 in people with Herpes Labialis, run by NanoBio Corporation at 28 sites in United States.
Trial summary
Purpose of this study is to determine the safety and efficacy of topical applications of NB-001 as compared to placebo for the treatment of recurrent herpes labialis. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- NB-001
- How many people
- 1,000 participants
- Where
- 28 sitesUnited States
- Study dates
- Feb 2007to Dec 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 80 years of age of either gender
- Good general health
- History of recurrent herpes labialis with at least 3 episodes per year
Who cannot join
- Pregnant and/or nursing female
- Lesions or irritation on or around the lips that would interfere with recognition of a herpes labialis attack
- Treatment with topical steroids, antivirals, or new topical products on or around the lips in the week prior to the onset of an attack
- Known allergies to topical creams, ointments or medications.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106-5239
Advanced Clinical Research Institute
Anaheim, California, 92801
Benchmark Research
Austin, Texas, 78705
DermResearch Inc.
Austin, Texas, 78759
Okatie Research Center, LLC
Beaufort, South Carolina, 29902
Advanced Clinical Research, Inc.
Boise, Idaho, 83704
J&S Studies Inc.
Bryan, Texas, 77802
New River Valley Research Institute
Christiansburg, Virginia, 24073
Clinical Research of West Florida
Clearwater, Florida, 33765
MI Center for Skin Care Research
Clinton Township, Michigan, 48038
Dermatology Treatment & Research Center
Dallas, Texas, 75230
Research Across America
Dallas, Texas, 75234
Clinical Physiology Associates
Fort Myers, Florida, 33916
Lederach Family Medicine
Harleysville, Pennsylvania, 19438
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801
R/D Clinical Research, Inc
Lake Jackson, Texas, 77566
DermResearch, PLCC
Louisville, Kentucky, 40217
Advanced Healthcare
Milwaukee, Wisconsin, 53209
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
The Savin Center, PC
New Haven, Connecticut, 06511
Suncoast Clinical Research
New Port Richey, Florida, 34652
Westover Heights Clinic
Portland, Oregon, 97210
Wake Research Associates, LLM
Raleigh, North Carolina, 27612
Omega Medical Research
Warwick, Rhode Island, 02888
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801
South Valley Dermatology Center
West Jordan, Utah, 84088
Westlake Medical Research
Westlake Village, California, 91361
Front Range Clinical Research
Wheat Ridge, Colorado, 80033
About this study
Official title: The Safety, Pharmacokinetics, and Efficacy of NB-001 (0.1%, 0.3%, 0.5%) in Subjects With Recurrent Herpes Labialis
Purpose of this study is to determine the safety and efficacy of topical applications of NB-001 as compared to placebo for the treatment of recurrent herpes labialis.
- Conditions
- Herpes Labialis
- Being tested
- NB-001
- Keywords
- cold sore
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NB-001Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to healing as assessed by the subject.
Secondary outcomes (1)
Percent of subjects with healing by days 3, 4,and 5 as assessed by the subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionDec 2007
- Study completionDec 2007
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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NanoBio Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Abramovits, MD, Principal investigator, Dermatology Treatment and Research CenterJeffrey Adelglass, MD, Principal investigator, Research Across AmericaMaurice Archuleta, MD, Principal investigator, Front Range Clinical ResearchBrian Bock, DO, Principal investigator, Bock Clinical Research IncorporatedAlicia Bucko, DO, Principal investigator, Academic Dermatology AssociatesTeresa Coats, MD, Principal investigator, Benchmark ResearchLisa Cohen, DO, Principal investigator, Suncoast Clinical ResearchJohn Eck, MD, Principal investigator, Advanced Clinical Research Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453401
- Sponsor's protocol ID
- NB-001-003
- Status last verified
- May 2008
- First submitted
- 26 Mar 2007
- Last updated
- 30 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety, Pharmacokinetics, and Efficacy of NB-001 (0.1%, 0.3%, 0.5%) in Subjects With Recurrent Herpes Labialis
- ClinicalTrials.gov ID
- NCT00453401
- Acronym / sponsor ID
- NB-001-003
- Conditions
- Herpes Labialis
- Keywords
- cold sore
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- NanoBio CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 28 Mar 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.
Purpose of this study is to determine the safety and efficacy of topical applications of NB-001 as compared to placebo for the treatment of recurrent herpes labialis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 80 years of age of either gender
- Good general health
- History of recurrent herpes labialis with at least 3 episodes per year
Key exclusion criteria (5 listed)
- Pregnant and/or nursing female
- Lesions or irritation on or around the lips that would interfere with recognition of a herpes labialis attack
- Treatment with topical steroids, antivirals, or new topical products on or around the lips in the week prior to the onset of an attack
- Known allergies to topical creams, ointments or medications.
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| NB-001 | Drug | – |
Primary outcome
Time to healing as assessed by the subject.
1 secondary outcome
Percent of subjects with healing by days 3, 4,and 5 as assessed by the subject.
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 30 May 2008.
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.
William Abramovits, MD principal investigator
Dermatology Treatment and Research Center
Jeffrey Adelglass, MD principal investigator
Research Across America
Maurice Archuleta, MD principal investigator
Front Range Clinical Research
28 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 NB-001 in people with Herpes Labialis, run by NanoBio Corporation at 28 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 3 inclusion and 5 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 30 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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?
Time to healing as assessed by the subject.. 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 30 May 2008.