Acne VulgarisPhase 2NCT02242760

P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris

A Phase 2 study testing SB204 2% and SB204 4% in people with Acne Vulgaris, run by Novan, Inc. at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks. 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?: SB204 2% and SB204 4%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 213 participants
Where: 20 sitesUnited States
Study dates: Nov 2014to Aug 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Moderate to severe acne
25-70 non-inflammatory lesions at Baseline
20-40 inflammatory lesions at Baseline

Who cannot join

Subjects with known allergy to any component of the test material or vehicle
Women who are pregnant or nursing

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

QST Site #103
Boca Raton, Florida, 33486
QST Site #112
Detroit, Michigan, 48202
QST Site #118
Encinitas, California, 92024
Qst acne site #1
Hot Springs, Arkansas, 71913
QST Site #117
Louisville, Kentucky, 40202
QST #105
Lynchburg, Virginia, 24501
QST Site # 121
Minneapolis, Minnesota, 55432
QST Site #107
New York, New York, 10155
QST Site # 116
Newnan, Georgia, 302636
QST Site #114
Norfolk, Virginia, 23507
QST Site # 110
Pinellas Park, Florida, 33781
QST Site #108
Rochester, New York, 14623
QST Site #109
Rochester, New York, 14625
QST Site #106
Salt Lake City, Utah, 84117
QST Site # 102
San Antonio, Texas, 78229
QST Site #111
San Diego, California, 92123
QST Site #113
San Diego, California, 92123
QST Site #119
Santa Monica, California, 90404
QST Site #104
Stony Brook, New York, 11790
QST Site #120
Warren, Michigan, 48088

Other trials in United States

About this study

Official title: A Phase 2, Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled Study Comparing the Efficacy, Tolerability, and Safety of SB204 Gel and Vehicle Gel Once or Twice Daily in the Treatment of Acne Vulgaris

Read the detailed description

A randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.

Conditions: Acne Vulgaris
Being tested: SB204 2%, SB204 4%, 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.

SB204 2%Drug
Also called NVN1000
Applied topically twice daily
SB204 4%Drug
Also called NVN1000
Applied topically daily
Vehicle GelDrug
Also called Placeco
Applied topically twice and once daily

Study groups in NCT02242760
Study group	Role	What they receive
SB204 2% Twice daily	Experimental	Twice daily SB204 2% Receives: Drug: SB204 2%
SB204 4% daily	Experimental	Once daily SB204 4% Receives: Drug: SB204 4%
Vehicle Gel Daily	Placebo comparator	Vehicle Gel Daily Receives: Drug: Vehicle Gel
Vehicle Gel Twice Daily	Placebo comparator	Twice daily Vehicle Gel Receives: Drug: Vehicle Gel
SB204 4% Twice Daily	Experimental	Twice daily SB204 4% Receives: Drug: SB204 4%

What is being measured

The primary outcome is the main question the study is designed to answer.

Absolute Change in Inflammatory Lesion Counts
Change in inflammatory lesion count from Baseline to Week 12
Measured: Baseline and Week 12
Absolute Change in Non-inflammatory Lesion Counts
Absolute Change in non-inflammatory lesion count from Baseline to Week 12
Measured: Baseline and Week 12
Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment
Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome.
Grade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions)
Measured: Baseline and Week 12

Secondary outcomes (3)

Percent Change in Inflammatory Lesion Count From Baseline to Week 12
The percent change in inflammatory lesion count from Baseline to Week 12
Measured: Baseline and Week 12
Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12
The percent change in non-inflammatory lesion count from Baseline to Week 12
Measured: Baseline and Week 12
Median Time to Improvement
Median time to a 35% improvement in inflammatory lesion counts (Kaplan-Meier estimate). The full range values presented below are estimates made from the Kaplan-Meier figure.
Measured: Baseline through Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Aug 2015

First posted17 Sep 2014 (estimated)
Study startNov 2014
Primary completionJun 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 213 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02242760
Sponsor's protocol ID: NI-AC202
Status last verified: May 2023
First submitted: 10 Sep 2014
Last updated: 31 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled Study Comparing the Efficacy, Tolerability, and Safety of SB204 Gel and Vehicle Gel Once or Twice Daily in the Treatment of Acne Vulgaris
ClinicalTrials.gov ID: NCT02242760
Acronym / sponsor ID: NI-AC202
Conditions: Acne Vulgaris
Keywords: acne
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 213 participants (actual)
Lead sponsor: Novan, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: Jun 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 17 Sep 2014 (estimated)
Results: Posted 31 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
SB204 2% Twice daily	Experimental	Drug: SB204 2%Twice daily SB204 2%
SB204 4% daily	Experimental	Drug: SB204 4%Once daily SB204 4%
Vehicle Gel Daily	Placebo comparator	Drug: Vehicle GelVehicle Gel Daily
Vehicle Gel Twice Daily	Placebo comparator	Drug: Vehicle GelTwice daily Vehicle Gel
SB204 4% Twice Daily	Experimental	Drug: SB204 4%Twice daily SB204 4%

Who may qualify

Ages: 12 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Moderate to severe acne
25-70 non-inflammatory lesions at Baseline
20-40 inflammatory lesions at Baseline

Key exclusion criteria (2 listed)

Subjects with known allergy to any component of the test material or vehicle
Women who are pregnant or nursing

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 2%Also: NVN1000Applied topically twice daily	Drug	SB204 2% Twice daily
SB204 4%Also: NVN1000Applied topically daily	Drug	SB204 4% Twice Daily, SB204 4% daily
Vehicle GelAlso: PlacecoApplied topically twice and once daily	Drug	Vehicle Gel Daily, Vehicle Gel Twice Daily

Primary outcome

Absolute Change in Inflammatory Lesion Counts
Time frame: Baseline and Week 12
Change in inflammatory lesion count from Baseline to Week 12
Absolute Change in Non-inflammatory Lesion Counts
Time frame: Baseline and Week 12
Absolute Change in non-inflammatory lesion count from Baseline to Week 12
Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment
Time frame: Baseline and Week 12
Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome. Grade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions)

3 secondary outcomes

Percent Change in Inflammatory Lesion Count From Baseline to Week 12
Time frame: Baseline and Week 12
Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12
Time frame: Baseline and Week 12
Median Time to Improvement
Time frame: Baseline through Week 12

Results and safety

Results posted to the registry on 31 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vehicle Gel QD	27	24
Vehicle Gel BID	29	20
SB204 2% BID	53	51
SB204 4% QD	52	48
SB204 4% BID	52	48

Primary outcome: Absolute Change in Inflammatory Lesion Counts

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: inflammatory acne lesions

Measure	Vehicle Gel QD n = 27	Vehicle Gel BID n = 29	SB204 2% BID n = 53	SB204 4% QD n = 52	SB204 4% BID n = 51
Value	-7.7 (10.51)	-4.1 (12.77)	-11.2 (9.48)	-11.3 (9.66)	-10.4 (9.65)

Population analysed: Intent to treat population (ITT)

Primary outcome: Absolute Change in Non-inflammatory Lesion Counts

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: non-inflammatory acne lesions

Measure	Vehicle Gel QD n = 27	Vehicle Gel BID n = 29	SB204 2% BID n = 53	SB204 4% QD n = 52	SB204 4% BID n = 51
Value	-8.4 (16.16)	-6.9 (18.16)	-12.3 (14.91)	-14.1 (15.13)	-11.1 (17.65)

Population analysed: Intent to treat (ITT) population

Primary outcome: Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment

Time frame: Baseline and Week 12. Count of participants. Unit: Participants

Measure	Vehicle Gel QD n = 27	Vehicle Gel BID n = 29	SB204 2% BID n = 53	SB204 4% QD n = 52	SB204 4% BID n = 51
Value	2	2	8	6	7

Population analysed: Intent to treat (ITT) population. Count of participants = number of participants achieving success on the Investigator's Global Assessment at Week 12: a score of clear (0) or almost clear (1) and at least 2 grades less than Baseline.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vehicle Gel QD	0 of 26 (0%)	1 of 26 (3.8%)	0 of 26
Vehicle Gel BID	0 of 29 (0%)	4 of 29 (13.8%)	0 of 29
SB204 2% BID	0 of 53 (0%)	4 of 53 (7.5%)	0 of 53
SB204 4% QD	1 of 52 (1.9%)	5 of 52 (9.6%)	0 of 52
SB204 4% BID	0 of 51 (0%)	3 of 51 (5.9%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

M J Rico, MD study director

Novan, Inc.

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SB204 2% and SB204 4% in people with Acne Vulgaris, run by Novan, Inc. at 20 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 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 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 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?

Yes. Results are posted in the registry (first posted 31 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Absolute Change in Inflammatory Lesion Counts (time frame: Baseline and Week 12). The study lists 3 primary outcomes in all. 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 NCT02242760.

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 31 May 2023.