Herpes LabialisPhase 3NCT01695187
NB-001 Treatment of Recurrent Herpes Labialis
A Phase 3 study testing NB-001 (0.3%) in people with Herpes Labialis, run by NanoBio Corporation at 12 sites in United States.
Trial summary
This is a study to test the hypothesis that time to healing of a cold sore will be lower in the active treatment arm of the study when compared to the vehicle (placebo). Subjects with a history of cold sores will be enrolled and administered active treatment or placebo in a blinded manner. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- NB-001 (0.3%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 362 participants
- Where
- 12 sitesUnited States
- Study dates
- Oct 2012to Jul 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 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 year. The majority of their cold sore recurrences proceeded by a well-defined history of prodromal symptoms including redness, pain, burning, tingling, itching, swelling or a tight sensation of the lip at the site of the outbreak;
- Be willing to refrain from using systemic or topical antiviral agents or systemic corticosteroids within 4 weeks prior to study drug administration and for the duration of the cold sore recurrence;
- Be willing to refrain from using any topical pharmaceutical or cosmetic products other than the study medication in or around the nasal and perioral areas for the duration of the cold sore recurrence;
- Be willing to refrain from participation in another clinical trial;
- Be willing and able to use phone or internet to obtain the combination to unlock their study medication kit;
- Be able to read and write in English and understand and comply with the protocol requirements;
- Be able to give informed consent and have signed a written informed consent form.
Who cannot join
- Known hypersensitivity to one of the drug ingredients, including soybean oil, polysorbate (Tween), alcohol, EDTA, or cetylpyridinium chloride (found in some mouthwashes and lozenges);
- Severe chronic illness including renal failure, severe respiratory or cardiac disease, chronic infections, immunodeficiency syndrome, uncontrolled diabetes mellitus or untreated severe thyroid disease;
- Received (within the last 6 months) or receiving chemotherapy;
- Significant skin disease on the face (such as atopic dermatitis, cystic acne, severe rosacea, eczema, psoriasis or other chronic vesiculobullous disorders) or lesions, wounds, abrasions, piercings, tattoos, irritation or other skin conditions on or around the nasal and perioral areas that would interfere with the treatment or assessment of the primary lesion complex. Subjects with mild controlled psoriasis, eczema, acne or dermatitis or other conditions may be included if the condition does not interfere with the ability to evaluate a herpes labialis lesion or local skin irritation;
- Previously received herpes vaccine;
- Active alcohol or drug abuse;
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- Prior randomization into any NanoBio study;
- Any condition that would potentially make them unable to participate for the entire trial period;
- Known allergies to topical creams, ointments or other topical medications.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Radiant Research, Inc.
Anderson, South Carolina, 29621
Radiant Research, Inc
Chandler, Arizona, 85224
Radiant Research, Inc. Chicago
Chicago, Illinois, 60654
New River Valley Research Institute
Christiansburg, Virginia, 24073
Research Across America
Dallas, Texas, 75234
Radiant Research, Inc.
Edina, Minnesota, 55435
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, 64114
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Radiant Research, Inc.
San Antonio, Texas, 78229
Radiant Research, Inc.
St Louis, Missouri, 63141
Radiant Research, Inc
Tucson, Arizona, 85710
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 Treatment of Recurrent Herpes Labialis
This is a study to test the hypothesis that time to healing of a cold sore will be lower in the active treatment arm of the study when compared to the vehicle (placebo). Subjects with a history of cold sores will be enrolled and administered active treatment or placebo in a blinded manner. Subjects will then be followed to assess time to healing.
- Conditions
- Herpes Labialis
- Being tested
- NB-001 (0.3%), Placebo
- Keywords
- Herpes, Herpes Labialis, nanoemulsion, NanoBio, NB-001
- Medical subject headings
- Herpes Labialis, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NB-001 (0.3%)Drug
Topical administration at least five times throughout the day
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| NB-001 (0.3%) | Experimental | NB-001 is an oil-in-water emulsion composed of nanometer-sized, positively charged droplets (average particle size = 180nm). NB-001 is composed of highly refined soybean oil, purified water, ethanol, edetate disodium dihydrate (EDTA) and two surfactants: polysorbate (Tween) 20 and cetylpyridinium chloride (CPC). Receives: Drug: NB-001 (0.3%) |
| Vehicle | Placebo comparator | NB-001 is an oil-in-water emulsion composed of nanometer-sized, positively charged droplets (average particle size = 180nm). NB-001 is composed of highly refined soybean oil, purified water, ethanol, edetate disodium dihydrate (EDTA) and one surfactant: polysorbate (Tween) 20. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 receiving the combination to unlock the medication and begin treatment to investigator assessed healing.
Measured: Time to healing will be assessed from treatment onset to resolution of symptoms (maximum of 16 days)
Secondary outcomes (1)
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: Proportion of subjects in whom the primary lesion complex does not progress will be assessed from treatment onset to resolution of symptoms (maximum of 16 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2013
- Study completionJul 2013 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 362 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
- NCT01695187
- Sponsor's protocol ID
- NB-001-010
- Status last verified
- Jun 2013
- First submitted
- 18 Sep 2012
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 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 Treatment of Recurrent Herpes Labialis
- ClinicalTrials.gov ID
- NCT01695187
- Acronym / sponsor ID
- NB-001-010
- Conditions
- Herpes Labialis
- Keywords
- Herpes, Herpes Labialis, nanoemulsion, NanoBio, NB-001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 362 participants (actual)
- Lead sponsor
- NanoBio CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (estimated)
- First posted
- 27 Sep 2012 (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.
This is a study to test the hypothesis that time to healing of a cold sore will be lower in the active treatment arm of the study when compared to the vehicle (placebo). Subjects with a history of cold sores will be enrolled and administered active treatment or placebo in a blinded manner. Subjects will then be followed to assess time to healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NB-001 (0.3%) | Experimental | Drug: NB-001 (0.3%)NB-001 is an oil-in-water emulsion composed of nanometer-sized, positively charged droplets (average particle size = 180nm). NB-001 is composed of highly refined soybean oil, purified water, ethanol, edetate disodium dihydrate (EDTA) and two surfactants: polysorbate (Tween) 20 and cetylpyridinium chloride (CPC). |
| Vehicle | Placebo comparator | Drug: PlaceboNB-001 is an oil-in-water emulsion composed of nanometer-sized, positively charged droplets (average particle size = 180nm). NB-001 is composed of highly refined soybean oil, purified water, ethanol, edetate disodium dihydrate (EDTA) and one surfactant: polysorbate (Tween) 20. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be 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 year. The majority of their cold sore recurrences proceeded by a well-defined history of prodromal symptoms including redness, pain, burning, tingling, itching, swelling or a tight sensation of the lip at the site of the outbreak;
- Be willing to refrain from using systemic or topical antiviral agents or systemic corticosteroids within 4 weeks prior to study drug administration and for the duration of the cold sore recurrence;
- Be willing to refrain from using any topical pharmaceutical or cosmetic products other than the study medication in or around the nasal and perioral areas for the duration of the cold sore recurrence;
- Be willing to refrain from participation in another clinical trial;
Key exclusion criteria (9 listed)
- Known hypersensitivity to one of the drug ingredients, including soybean oil, polysorbate (Tween), alcohol, EDTA, or cetylpyridinium chloride (found in some mouthwashes and lozenges);
- Severe chronic illness including renal failure, severe respiratory or cardiac disease, chronic infections, immunodeficiency syndrome, uncontrolled diabetes mellitus or untreated severe thyroid disease;
- Received (within the last 6 months) or receiving chemotherapy;
- Significant skin disease on the face (such as atopic dermatitis, cystic acne, severe rosacea, eczema, psoriasis or other chronic vesiculobullous disorders) or lesions, wounds, abrasions, piercings, tattoos, irritation or other skin conditions on or around the nasal and perioral areas that would interfere with the treatment or assessment of the primary lesion complex. Subjects with mild controlled psoriasis, eczema, acne or dermatitis or other conditions may be included if the condition does not interfere with the ability to evaluate a herpes labialis lesion or local skin irritation;
- Previously received herpes vaccine;
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 (0.3%)Topical administration at least five times throughout the day | Drug | NB-001 (0.3%) |
| Placebo | Drug | Vehicle |
Primary outcome
Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator.
Time frame: Time to healing will be assessed from treatment onset to resolution of symptoms (maximum of 16 days)
Time to healing is the time from receiving the combination to unlock the medication and begin treatment 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: Proportion of subjects in whom the primary lesion complex does not progress will be assessed from treatment onset to resolution of symptoms (maximum of 16 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NB-001 (0.3%) in people with Herpes Labialis, run by NanoBio Corporation at 12 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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Results are not available in the source record.
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 of the primary lesion complex (in days or fraction thereof) as assessed by the investigator. (time frame: Time to healing will be assessed from treatment onset to resolution of symptoms (maximum of 16 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 14 Jun 2013.