Acne VulgarisPhase 2NCT01844752
A Phase 2, 3 Arm Study of NVN1000 Gel and Vehicle Gel in Subjects With Acne
A Phase 2 study testing NVN1000 1% Gel and NVN1000 4% Gel in people with Acne Vulgaris, run by Novan, Inc. at 3 sites in 3 countries.
Trial summary
This is a 12 week clinical trial in subjects with acne vulgaris. Subjects will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel twice daily. Safety, tolerability and efficacy will be assessed over the course of the study. Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- NVN1000 1% Gel and NVN1000 4% Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2013to Nov 2013
- 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 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects with acne vulgaris and at least 20 but no more than 40 inflammatory lesions, 25-70 non-inflammatory lesions, no more than 2 nodules on the face
- Baseline IGA score of mild, moderate or severe
- Women of child-bearing potential must agree to use an effective method of birth control during the study and for 30 days after their final study visit
Who cannot join
- Any dermatologic condition or other medical problem that could interfere with clinical evaluation or requires the use of topical or systemic therapy that make evaluations and lesion count inconclusive
- Female subjects who are pregnant, nursing, or considering becoming pregnant
- Methemoglobin > 2% at baseline
- Clinically significant anemia at baseline
- Use of topical or systemic medications to treat acne
- Use of medications that make acne worse, associated with methemoglobinemia, or nitric oxide donors
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Dominican Republic1 site
Instituto Dermatologico & Cirugia de Piel
Santo Domingo
About this study
Official title: A Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled, Parallel Group, 3-arm Study Comparing the Efficacy, Tolerability and Safety of 2 Concentrations of NVN1000 Gel and Vehicle Gel Twice Daily in the Treatment of Acne Vulgaris.
This is a 12 week clinical trial in subjects with acne vulgaris. Subjects will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel twice daily. Safety, tolerability and efficacy will be assessed over the course of the study.
Read the detailed description
This is a multi-center, evaluator and subject blinded, randomized, vehicle-controlled, parallel group, dose-ranging study to be conducted in approximately 150 subjects with acne vulgaris. Subjects who satisfy the entry criteria at the Baseline visit will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel in a 1:1:1 ratio. Efficacy assessments will include inflammatory and non-inflammatory lesion counts and investigator global assessments (IGA). Tolerability and safety assessments include cutaneous tolerability evaluation, adverse event collection, physical exams, and laboratory studies. Subjects will return for post-baseline evaluation at Weeks 2, 4, 8, and 12.
- Conditions
- Acne Vulgaris
- Being tested
- NVN1000 1% Gel, NVN1000 4% Gel, Vehicle Gel
- Keywords
- acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVN1000 1% GelDrug
Also called NVN1000
Twice daily NVN1000 1% Gel for 12 weeks
NVN1000 4% GelDrug
Also called NVN1000
Twice daily NVN1000 4% Gel for 12 weeks
Vehicle GelDrug
Also called Comparator Gel
Twice daily Vehicle Gel for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| NVN1000 1% Gel | Experimental | NVN1000 1% Gel twice daily Receives: Drug: NVN1000 1% Gel |
| NVN1000 4% Gel | Experimental | NVN1000 4% Gel twice daily Receives: Drug: NVN1000 4% Gel |
| Vehicle Gel | Placebo comparator | Vehicle Gel twice daily Receives: Drug: Vehicle Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absolute change from baseline in non-inflammatory lesion counts at Week 12
The absolute change from baseline in non-inflammatory lesion counts at Week 12
Measured: 12 weeks
Secondary outcomes (2)
The absolute change from baseline in inflammatory lesion counts at Week 12
The absolute change from baseline in inflammatory lesion counts at Week 12
Measured: 12 weeks
Success on the Investigator Global Assessment (IGA) at Week 12
Analysis of the dichotomized IGA scores (success vs failure) at Week 12. "Success" is defined as a score of "clear" or "almost clear" and a 2 point improvement in the IGA score from Baseline.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2013
- Study completionNov 2013
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joyce Rico, MD, Study director, Novan, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844752
- Sponsor's protocol ID
- NI-AC201
- Status last verified
- Nov 2018
- First submitted
- 29 Apr 2013
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Baldwin H, Blanco D, McKeever C, Paz N, Vasquez YN, Quiring J, Enloe C, De Leon E, Stasko N. Results of a Phase 2 Efficacy and Safety Study with SB204, an Investigational Topical Nitric Oxide-releasing Drug for the Treatment of Acne Vulgaris. J Clin Aesthet Dermatol. 2016 Aug;9(8):12-8. Epub 2016 Aug 1.
PubMed 27672413
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled, Parallel Group, 3-arm Study Comparing the Efficacy, Tolerability and Safety of 2 Concentrations of NVN1000 Gel and Vehicle Gel Twice Daily in the Treatment of Acne Vulgaris.
- ClinicalTrials.gov ID
- NCT01844752
- Acronym / sponsor ID
- NI-AC201
- Conditions
- Acne Vulgaris
- Keywords
- acne
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Novan, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 1 May 2013 (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 12 week clinical trial in subjects with acne vulgaris. Subjects will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel twice daily. Safety, tolerability and efficacy will be assessed over the course of the study.
Detailed description
This is a multi-center, evaluator and subject blinded, randomized, vehicle-controlled, parallel group, dose-ranging study to be conducted in approximately 150 subjects with acne vulgaris. Subjects who satisfy the entry criteria at the Baseline visit will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel in a 1:1:1 ratio. Efficacy assessments will include inflammatory and non-inflammatory lesion counts and investigator global assessments (IGA). Tolerability and safety assessments include cutaneous tolerability evaluation, adverse event collection, physical exams, and laboratory studies. Subjects will return for post-baseline evaluation at Weeks 2, 4, 8, and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NVN1000 1% Gel | Experimental | Drug: NVN1000 1% GelNVN1000 1% Gel twice daily |
| NVN1000 4% Gel | Experimental | Drug: NVN1000 4% GelNVN1000 4% Gel twice daily |
| Vehicle Gel | Placebo comparator | Drug: Vehicle GelVehicle Gel twice daily |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Subjects with acne vulgaris and at least 20 but no more than 40 inflammatory lesions, 25-70 non-inflammatory lesions, no more than 2 nodules on the face
- Baseline IGA score of mild, moderate or severe
- Women of child-bearing potential must agree to use an effective method of birth control during the study and for 30 days after their final study visit
Key exclusion criteria (6 listed)
- Any dermatologic condition or other medical problem that could interfere with clinical evaluation or requires the use of topical or systemic therapy that make evaluations and lesion count inconclusive
- Female subjects who are pregnant, nursing, or considering becoming pregnant
- Methemoglobin > 2% at baseline
- Clinically significant anemia at baseline
- Use of topical or systemic medications to treat acne
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 |
|---|---|---|
| NVN1000 1% GelAlso: NVN1000Twice daily NVN1000 1% Gel for 12 weeks | Drug | NVN1000 1% Gel |
| NVN1000 4% GelAlso: NVN1000Twice daily NVN1000 4% Gel for 12 weeks | Drug | NVN1000 4% Gel |
| Vehicle GelAlso: Comparator GelTwice daily Vehicle Gel for 12 weeks | Drug | Vehicle Gel |
Primary outcome
The absolute change from baseline in non-inflammatory lesion counts at Week 12
Time frame: 12 weeks
The absolute change from baseline in non-inflammatory lesion counts at Week 12
2 secondary outcomes
The absolute change from baseline in inflammatory lesion counts at Week 12
Time frame: 12 weeks
Success on the Investigator Global Assessment (IGA) at Week 12
Time frame: 12 week
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 19 Nov 2018.
- Derived from this study: PubMed 27672413Baldwin H, Blanco D, McKeever C, Paz N, Vasquez YN, Quiring J, Enloe C, De Leon E, Stasko N. Results of a Phase 2 Efficacy and Safety Study with SB204, an Investigational Topical Nitric Oxide-releasing Drug for the Treatment of Acne Vulgaris. J Clin Aesthet Dermatol. 2016 Aug;9(8):12-8. Epub 2016 Aug 1.
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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.
Joyce Rico, MD study director
Novan, Inc.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NVN1000 1% Gel and NVN1000 4% Gel in people with Acne Vulgaris, run by Novan, Inc. at 3 sites in 3 countries.
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 6 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 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Dominican Republic, Honduras, Panama. 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 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?
The absolute change from baseline in non-inflammatory lesion counts at Week 12 (time frame: 12 weeks). 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 NCT01844752, 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 19 Nov 2018.