Acne VulgarisPhase 1NCT01694810
Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers
A Phase 1 study testing 2% NVN1000 Topical Gel, 4% NVN1000 Topical Gel and 8% NVN1000 Topical Gel in people with Acne Vulgaris, run by Novan, Inc. at 1 site in United States.
Trial summary
The study will assess safety and tolerability of different doses of topical gel containing a new chemical entity, NVN1000, and the vehicle (gel without drug) applied to the face of healthy volunteers with high counts of Propionibacterium acnes. The test product will be applied once daily for 4 weeks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- 2% NVN1000 Topical Gel, 4% NVN1000 Topical Gel and 8% NVN1000 Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Nov 2012
- Phase
- Phase 1
- 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
- Healthy male and female volunteers
- Age 18 or older
- High degree of fluorescence of facial skin under Wood's lamp
Who cannot join
- Acute or chronic skin disorders
- Use of topical or systemic antibiotics within 4 weeks of study
- Concomitant use of nitroglycerin or other nitric oxide donor drugs
- Females who are pregnant, planning pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Multiple Dose, Single-Center, Observer-Blind Parallel Group Study Evaluating Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers
The study will assess safety and tolerability of different doses of topical gel containing a new chemical entity, NVN1000, and the vehicle (gel without drug) applied to the face of healthy volunteers with high counts of Propionibacterium acnes. The test product will be applied once daily for 4 weeks. Exploratory measures include whether the topical product decreases the amount of a bacteria associated with acne (P. acnes).
Read the detailed description
This is a single center, observer blinded, randomized, multiple dose study with 3 doses of NVN1000 and vehicle applied once daily for 4 weeks. There are 4 arms to the study (3 active and 1 vehicle).
- Conditions
- Acne Vulgaris
- Being tested
- 2% NVN1000 Topical Gel, 4% NVN1000 Topical Gel, 8% NVN1000 Topical Gel, Vehicle Topical Gel
- Keywords
- acne vulgaris
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% NVN1000 Topical GelDrug
Also called NVN1000
2% NVN1000 Topical Gel once daily for 4 weeks
4% NVN1000 Topical GelDrug
Also called NVN1000
4% NVN1000 4% Topical Gel applied once daily 4 weeks
8% NVN1000 Topical GelDrug
Also called NVN1000
8% NVN1000 Topical Gel applied once daily for 4 weeks
Vehicle Topical GelDrug
Also called Vehicle
Vehicle Topical Gel applied once daily
| Study group | Role | What they receive |
|---|---|---|
| 2% NVN1000 Topical Gel | Experimental | 2% NVN1000 Topical Gel once daily for 4 weeks Receives: Drug: 2% NVN1000 Topical Gel |
| 4% NVN1000 Topical Gel | Experimental | 4% NVN1000 4% Topical Gel once daily for 4 weeks Receives: Drug: 4% NVN1000 Topical Gel |
| Vehicle Topical Gel | Placebo comparator | Vehicle Topical Gel once daily for 4 weeks Receives: Drug: Vehicle Topical Gel |
| 8% NVN1000 Topical Gel | Experimental | 8% NVN1000 8% Topical Gel applied once daily for 4 weeks Receives: Drug: 8% NVN1000 Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous tolerability Evaluation
Cutaneous tolerability evaluations to include erythema, scaling, dryness, puritus and burning/stinging using a 4-category scale with scores ranging from 0-3 (0=none, 1=mild, 2=moderate, 3 - severe).
Measured: 4 weeks
Secondary outcomes (18)
Safety Assessment
Comparison of adverse events between groups.
Measured: 4 weeks
Safety Assessment
Change from baseline in HCT (L/L)
Measured: 4 weeks
Safety Assessment
Change from baseline in HGB, MCHC (g/L)
Measured: 4 weeks
Safety Assessment
Change from baseline in % methemoglobin (%)
Measured: 4 weeks
Safety Assessment
Change from baseline in % Basophils (%)
Measured: 4 weeks
Safety Assessment
Change from baseline in % Eosinophils (%)
Measured: 4 weeks
Safety Assessment
Change from baseline in % Lymphocytes (%)
Measured: 4 weeks
Safety Assessment
Change from baseline in MCH (pg)
Measured: 4 weeks
Safety Assessment
Change from baseline in MCV, MPV (fL)
Measured: 4 weeks
Safety Assessment
Change from baseline in % Monocytes (%)
Measured: 4 weeks
Safety Assessment
Change from baseline in % Neutrophils (%)
Measured: 4 weeks
Safety Assessment
Change from baseline in Platelet Count, WBC (10 ^ 9/L)
Measured: 4 weeks
Safety Assessment
Change from baseline in % RDW (%)
Measured: 4 weeks
Safety Assessment
Change from baseline in RBC (10 ^ 12/L)
Measured: 4 weeks
Safety Assessment
Change from baseline in Albumin, Protein, Total (g/L)
Measured: 4 weeks
Safety Assessment
Change from baseline in Alkaline Phosphatase, ALT, AST, (U/L)
Measured: 4 weeks
Safety Assessment
Change from baseline in Bicarbonate, Bun, Calcium, Chloride, Glucose, Phosphorus, Potassium, Sodium (mmol/L)
Measured: 4 weeks
Safety Assessment
Change from baseline in Bilirubin Direct, Bilirubin Total, Creatinine (umol/ L)
Measured: 4 weeks
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 startSep 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James J Leyden, MD, Principal investigator, KGL, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694810
- Sponsor's protocol ID
- NI-AC002
- Status last verified
- Jan 2020
- First submitted
- 25 Sep 2012
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multiple Dose, Single-Center, Observer-Blind Parallel Group Study Evaluating Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01694810
- Acronym / sponsor ID
- NI-AC002
- Conditions
- Acne Vulgaris
- Keywords
- acne vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Novan, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- 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.
The study will assess safety and tolerability of different doses of topical gel containing a new chemical entity, NVN1000, and the vehicle (gel without drug) applied to the face of healthy volunteers with high counts of Propionibacterium acnes. The test product will be applied once daily for 4 weeks. Exploratory measures include whether the topical product decreases the amount of a bacteria associated with acne (P. acnes).
Detailed description
This is a single center, observer blinded, randomized, multiple dose study with 3 doses of NVN1000 and vehicle applied once daily for 4 weeks. There are 4 arms to the study (3 active and 1 vehicle).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2% NVN1000 Topical Gel | Experimental | Drug: 2% NVN1000 Topical Gel2% NVN1000 Topical Gel once daily for 4 weeks |
| 4% NVN1000 Topical Gel | Experimental | Drug: 4% NVN1000 Topical Gel4% NVN1000 4% Topical Gel once daily for 4 weeks |
| Vehicle Topical Gel | Placebo comparator | Drug: Vehicle Topical GelVehicle Topical Gel once daily for 4 weeks |
| 8% NVN1000 Topical Gel | Experimental | Drug: 8% NVN1000 Topical Gel8% NVN1000 8% Topical Gel applied once daily for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male and female volunteers
- Age 18 or older
- High degree of fluorescence of facial skin under Wood's lamp
Key exclusion criteria (4 listed)
- Acute or chronic skin disorders
- Use of topical or systemic antibiotics within 4 weeks of study
- Concomitant use of nitroglycerin or other nitric oxide donor drugs
- Females who are pregnant, planning pregnancy or breast feeding
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 |
|---|---|---|
| 2% NVN1000 Topical GelAlso: NVN10002% NVN1000 Topical Gel once daily for 4 weeks | Drug | 2% NVN1000 Topical Gel |
| 4% NVN1000 Topical GelAlso: NVN10004% NVN1000 4% Topical Gel applied once daily 4 weeks | Drug | 4% NVN1000 Topical Gel |
| 8% NVN1000 Topical GelAlso: NVN10008% NVN1000 Topical Gel applied once daily for 4 weeks | Drug | 8% NVN1000 Topical Gel |
| Vehicle Topical GelAlso: VehicleVehicle Topical Gel applied once daily | Drug | Vehicle Topical Gel |
Primary outcome
Cutaneous tolerability Evaluation
Time frame: 4 weeks
Cutaneous tolerability evaluations to include erythema, scaling, dryness, puritus and burning/stinging using a 4-category scale with scores ranging from 0-3 (0=none, 1=mild, 2=moderate, 3 - severe).
18 secondary outcomes
Safety Assessment
Time frame: 4 weeks
Safety Assessment
Time frame: 4 weeks
Safety Assessment
Time frame: 4 weeks
Safety Assessment
Time frame: 4 weeks
Safety Assessment
Time frame: 4 weeks
Safety Assessment
Time frame: 4 weeks
Safety Assessment
Time frame: 4 weeks
Safety Assessment
Time frame: 4 weeks
Safety Assessment
Time frame: 4 weeks
Safety Assessment
Time frame: 4 weeks
Safety Assessment
Time frame: 4 weeks
Safety Assessment
Time frame: 4 weeks
Safety Assessment
Time frame: 4 weeks
Safety Assessment
Time frame: 4 weeks
Safety Assessment
Time frame: 4 weeks
Safety Assessment
Time frame: 4 weeks
Safety Assessment
Time frame: 4 weeks
Safety Assessment
Time frame: 4 weeks
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 Jan 2020.
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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.
James J Leyden, MD principal investigator
KGL, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 2% NVN1000 Topical Gel, 4% NVN1000 Topical Gel and 8% NVN1000 Topical Gel in people with Acne Vulgaris, run by Novan, Inc. at 1 site 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 4 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 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Cutaneous tolerability Evaluation (time frame: 4 weeks). 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 Jan 2020.