Acne VulgarisPhase 1NCT02581072
A Thorough ECG Study in Subjects With Acne Vulgaris Treated With SB204
A Phase 1 study testing SB204 4% and SB204 8% or 12% in people with Acne Vulgaris, run by Novan, Inc. at 1 site in United States.
Trial summary
A Double-Blind, Double-Dummy, Randomized, 4-Period Crossover Study to Define the ECG Effects of SB204 Using a Clinical and Supratherapeutic Dose Compared with Placebo and Moxifloxacin (a Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- SB204 4% and SB204 8% or 12%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Apr 2016
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe acne
- 20 inflammatory and 25 non-inflammatory acne lesions
Who cannot join
- Pregnant, trying to become pregnant, or nursing
- Known allergy to any component of the topical SB204 formulation
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research, LLC
West Bend, Wisconsin, 53095
About this study
Official title: A Double-blind, Double-dummy, Randomized, 4-period Crossover Study to Define the ECG Effects of SB204 Using a Clinical and Supratherapeutic Dose Compared With Placebo and Moxifloxacin in Subjects With Acne Vulgaris: A Thorough ECG STudy
A Double-Blind, Double-Dummy, Randomized, 4-Period Crossover Study to Define the ECG Effects of SB204 Using a Clinical and Supratherapeutic Dose Compared with Placebo and Moxifloxacin (a Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study
Read the detailed description
A Double-Blind, Double-Dummy, Randomized, 4-Period, Crossover Study to Define the ECG Effects of SB204 Using a Clinical and a Supratherapeutic Dose Compared with Placebo and Moxifloxacin (a Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study
- Conditions
- Acne Vulgaris
- Being tested
- SB204 4%, SB204 8% or 12%, Vehicle
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB204 4%Drug
Also called NVN1000
Applied topically once
SB204 8% or 12%Drug
Also called NVN1000
Applied once topically
VehicleDrug
Also called Placebo
Applied topically once
| Study group | Role | What they receive |
|---|---|---|
| SB204 4% | Experimental | SB204 4% once Receives: Drug: SB204 4% |
| SB204 8% or 12 % | Experimental | SB204 8 or 12 % (supratherapeutic) once Receives: Drug: SB204 8% or 12% |
| Moxifloxacillin | No intervention | Moxifloxacillin 400 mg orally |
| Vehicle Gel | Placebo comparator | Placebo Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define ECG effect of SB204 at therapeutic and supratherapeutic dose concentrations as measured by the difference between time-matched baseline adjusted QTcF interval for the groups recieving SB204 and placebo.
Measured: 15 days
Secondary outcomes (1)
Categorical analysis of the QTc interval to determine number and percentage of time points and subjects by dose group with absolute QT/QTc > 450, 480, and 500 ms.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionApr 2016
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Spaulding Clinical Research LLC
- Responsible party
- Sponsor
- Investigators
- Joyce Rico, MD, Principal investigator, Novan, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581072
- Sponsor's protocol ID
- NI-AC104
- Status last verified
- Nov 2018
- First submitted
- 15 Oct 2015
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 Double-blind, Double-dummy, Randomized, 4-period Crossover Study to Define the ECG Effects of SB204 Using a Clinical and Supratherapeutic Dose Compared With Placebo and Moxifloxacin in Subjects With Acne Vulgaris: A Thorough ECG STudy
- ClinicalTrials.gov ID
- NCT02581072
- Acronym / sponsor ID
- NI-AC104
- Conditions
- Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Novan, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Spaulding Clinical Research LLC
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 Oct 2015 (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.
A Double-Blind, Double-Dummy, Randomized, 4-Period Crossover Study to Define the ECG Effects of SB204 Using a Clinical and Supratherapeutic Dose Compared with Placebo and Moxifloxacin (a Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study
Detailed description
A Double-Blind, Double-Dummy, Randomized, 4-Period, Crossover Study to Define the ECG Effects of SB204 Using a Clinical and a Supratherapeutic Dose Compared with Placebo and Moxifloxacin (a Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SB204 4% | Experimental | Drug: SB204 4%SB204 4% once |
| SB204 8% or 12 % | Experimental | Drug: SB204 8% or 12%SB204 8 or 12 % (supratherapeutic) once |
| Moxifloxacillin | No intervention | –Moxifloxacillin 400 mg orally |
| Vehicle Gel | Placebo comparator | Drug: VehiclePlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate to severe acne
- 20 inflammatory and 25 non-inflammatory acne lesions
Key exclusion criteria (2 listed)
- Pregnant, trying to become pregnant, or nursing
- Known allergy to any component of the topical SB204 formulation
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 |
|---|---|---|
| SB204 4%Also: NVN1000Applied topically once | Drug | SB204 4% |
| SB204 8% or 12%Also: NVN1000Applied once topically | Drug | SB204 8% or 12 % |
| VehicleAlso: PlaceboApplied topically once | Drug | Vehicle Gel |
Primary outcome
Define ECG effect of SB204 at therapeutic and supratherapeutic dose concentrations as measured by the difference between time-matched baseline adjusted QTcF interval for the groups recieving SB204 and placebo.
Time frame: 15 days
1 secondary outcome
Categorical analysis of the QTc interval to determine number and percentage of time points and subjects by dose group with absolute QT/QTc > 450, 480, and 500 ms.
Time frame: 15 days
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.
- Individual participant dataSharing planned: No
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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 principal investigator
Novan, 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 SB204 4% and SB204 8% or 12% 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 2 inclusion and 2 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 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?
Define ECG effect of SB204 at therapeutic and supratherapeutic dose concentrations as measured by the difference between time-matched baseline adjusted QTcF interval for the groups recieving SB204 and placebo. (time frame: 15 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 19 Nov 2018.