Recurrent Herpes Simplex LabialisPhase 3SHaRCSNCT01321359
A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis
A Phase 3 study of Recurrent Herpes Simplex Labialis, run by NanoBio Corporation at 35 sites in United States.
Trial summary
Demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Recurrent Herpes Simplex Labialis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 907 participants
- Where
- 35 sitesUnited States
- Study dates
- Apr 2011to Jan 2012
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A Healthy man or woman 18 years of age or older. Women who are pregnant, lactating or may become pregnant may (at the investigator's discretion) be included in the study.
- Have recurrent herpes labialis as defined by a history of three (3) or more cold sore recurrences on the lips and/or skin surrounding the lips in the previous 12 months;
- Have the majority of their cold sore recurrences proceeded by a well defined history of prodromal symptoms.
Who cannot join
- Subjects with severe chronic illness
- Received (within the last 6 months) or receiving chemotherapy;
- Significant skin disease on the face
- Previously received herpes vaccine;
- Active alcohol or drug abuse;
- Prior randomization into any NanoBio study;
- Known allergies to topical creams, ointments or other topical medications.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
ACR-Phase 1, LLC.
Anaheim, California, 92801
Radiant Research, Inc
Atlanta, Georgia, 30342
Pioneer Clinical Research, LLC
Bellevue, Nebraska, 68005
Radiant Research, Inc
Chandler, Arizona, 85225
New River Valley Research Institute
Christiansburg, Virginia, 24073
Michigan Center for Research Corp, DBA Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038
J&S Studies, Inc.
College Station, Texas, 77845
Radiant Research-Dallas North
Dallas, Texas, 75231
Avail Clinical Research, LLC
DeLand, Florida, 32720
Intermountain Clinical Research
Draper, Utah, 84020
Radiant Research, Inc.
Edina, Minnesota, 55435
Regional Clinical Research, Inc.
Endwell, New York, 13760
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714
Clinical Study Center
Fort Myers, Florida, 33916
Benchmark Research
Fort Worth, Texas, 76135
Radiant Research, Inc
Greer, South Carolina, 29651
AGA Clinical Trials
Hialeah, Florida, 33012
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509
Longmont Medical Research Network
Longmont, Colorado, 80501
Advanced Clinical Research
Meridan, Idaho, 83642
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
Orlando Clinical Research Center
Orlando, Florida, 32809
Radiant Research, Inc.
Overland Park, Kansas, 66202
Paddington Testing Co, Inc
Philadelphia, Pennsylvania, 19103
Primary Physicians Research
Pittsburgh, Pennsylvania, 15241
Research Across America
Plano, Texas, 75093
Progressive Medical Research
Port Orange, Florida, 32127
Westover Heights Clinic
Portland, Oregon, 97210
Northern California Research
Sacramento, California, 95821
Medical Center for Clinical Research
San Diego, California, 92108
Radiant Research, Inc
Santa Rosa, California, 95405
Radiant Research, Inc
Scottsdale, Arizona, 85251
Westlake Medical Research
Westlake Village, California, 91361
Physicians' Research, Inc.
Zanesville, Ohio, 43701
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis
Demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL).
Read the detailed description
This is a randomized, double-blind, two arm, parallel-group, vehicle-controlled, multi-center study of NB-001. The study is designed to demonstrate the safety and efficacy of NB-001 in subjects with RHL. Approximately 850 subjects who meet all eligibility criteria will be randomized in the study. Subjects will begin treatment as soon as they experience the onset of cold sore symptoms. Treatment will be applied 5 times daily, approximately 3-4 hours apart while awake. Treatment will continue until the investigator assesses the primary lesion complex as healed or a maximum of 4 days.
Clinic visits will occur on a daily basis until the investigator determines that the primary lesion complex has healed or a maximum of 15 clinic visits. At daily clinic visits, the investigator will make efficacy assessments of the primary lesion complex; safety and tolerability assessments of NB-001 following topical administration will also be assessed daily. Subjects will make daily assessments of therapy.
At the End of Study, the investigator will make a global assessment of therapy. The subject will make global assessments of therapy and social impact.
- Conditions
- Recurrent Herpes Simplex Labialis
- Being tested
- Vehicle versus NB-001
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vehicle versus NB-001Drug
Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Vehicle Receives: Drug: Vehicle versus NB-001 |
| Active | Active comparator | Active NB-001(0.3%) Receives: Drug: Vehicle versus NB-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of Healing of the primary lesion complex
Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator. Time to healing is the time from application of the first dose to investigator assessed healing
Measured: Days
Secondary outcomes (1)
Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage.
Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage. This analysis will be performed in the cohort of subjects whose primary lesion complex is assessed as being in the Prodrome (pain, burning, tingling, itching, redness, swelling, or a tight sensation of the lip), Erythema/Macule, Papule/Edema, or Aborted Stage by the investigator at the first post-treatment visit.
Measured: First Post-Treatment Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Herpes Simplex 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 907 participants (actual)
Sponsor and investigators
- Lead sponsor
- NanoBio Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321359
- Sponsor's protocol ID
- NB-001-004
- Acronym
- SHaRCS
- Status last verified
- May 2013
- First submitted
- 22 Mar 2011
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis
- ClinicalTrials.gov ID
- NCT01321359
- Acronym / sponsor ID
- SHaRCS / NB-001-004
- Conditions
- Recurrent Herpes Simplex Labialis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 907 participants (actual)
- Lead sponsor
- NanoBio CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 23 Mar 2011 (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.
Demonstrate the safety and efficacy of NB-001 in subjects with recurrent herpes labialis (RHL).
Detailed description
This is a randomized, double-blind, two arm, parallel-group, vehicle-controlled, multi-center study of NB-001. The study is designed to demonstrate the safety and efficacy of NB-001 in subjects with RHL. Approximately 850 subjects who meet all eligibility criteria will be randomized in the study. Subjects will begin treatment as soon as they experience the onset of cold sore symptoms. Treatment will be applied 5 times daily, approximately 3-4 hours apart while awake. Treatment will continue until the investigator assesses the primary lesion complex as healed or a maximum of 4 days.
Clinic visits will occur on a daily basis until the investigator determines that the primary lesion complex has healed or a maximum of 15 clinic visits. At daily clinic visits, the investigator will make efficacy assessments of the primary lesion complex; safety and tolerability assessments of NB-001 following topical administration will also be assessed daily. Subjects will make daily assessments of therapy.
At the End of Study, the investigator will make a global assessment of therapy. The subject will make global assessments of therapy and social impact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Drug: Vehicle versus NB-001Vehicle |
| Active | Active comparator | Drug: Vehicle versus NB-001Active NB-001(0.3%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A Healthy man or woman 18 years of age or older. Women who are pregnant, lactating or may become pregnant may (at the investigator's discretion) be included in the study.
- Have recurrent herpes labialis as defined by a history of three (3) or more cold sore recurrences on the lips and/or skin surrounding the lips in the previous 12 months;
- Have the majority of their cold sore recurrences proceeded by a well defined history of prodromal symptoms.
Key exclusion criteria (7 listed)
- Subjects with severe chronic illness
- Received (within the last 6 months) or receiving chemotherapy;
- Significant skin disease on the face
- Previously received herpes vaccine;
- Active alcohol or drug abuse;
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 |
|---|---|---|
| Vehicle versus NB-001Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days | Drug | Active, Vehicle |
Primary outcome
Time of Healing of the primary lesion complex
Time frame: Days
Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator. Time to healing is the time from application of the first dose to investigator assessed healing
1 secondary outcome
Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage.
Time frame: First Post-Treatment Visit
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 23 May 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Recurrent Herpes Simplex Labialis, run by NanoBio Corporation at 35 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 7 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 23 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 of Healing of the primary lesion complex (time frame: 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 23 May 2013.