- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02667444
P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne
July 12, 2023 updated by: Novan, Inc.
A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of Once Daily SB204 and Vehicle Gel in the Treatment of Acne Vulgaris
This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.
Study Overview
Detailed Description
This is a double-blind, placebo controlled study in subjects with moderate to severe acne.
Subjects who satisfy the entry criteria will be randomized to SB204 4% QD or Vehicle Gel QD in a 1:1 ratio.
Efficacy assessments will include Investigator Global Assessments (IGA) and inflammatory and non-inflammatory lesion counts.
Subjects will return for post-Baseline evaluation at Weeks 2, 4, 8, and 12/Early Termination (ET).
Study Type
Interventional
Enrollment (Actual)
1330
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- CIL #214
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Mobile, Alabama, United States, 36608
- CIL #218
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Arizona
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Phoenix, Arizona, United States, 85018
- CIL #189
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California
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Cerritos, California, United States, 90703
- CIL #139
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Chula Vista, California, United States, 91911
- CIL #216
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Encino, California, United States, 91436
- CIL #181
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Huntington Beach, California, United States, 92647
- CIL #174
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La Mesa, California, United States, 91942
- CIL #213
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Sacramento, California, United States, 95821
- CIL #190
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San Diego, California, United States, 92123
- CIL #111
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Santa Ana, California, United States, 92705
- CIL #195
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Santa Monica, California, United States, 90404
- CIL #119
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Florida
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Bradenton, Florida, United States, 34201
- CIL #158
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Hialeah, Florida, United States, 33012
- CIL #208
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Miami, Florida, United States, 33157
- CIL #142
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Miami Lakes, Florida, United States, 33016
- CIL #170
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Miami Springs, Florida, United States, 33166
- CIL #204
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Ormond Beach, Florida, United States, 32174
- CIL #185
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Pinellas Park, Florida, United States, 33781
- CIL #110
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Saint Petersburg, Florida, United States, 33716
- CIL #176
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Sanford, Florida, United States, 32771
- CIL #227
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Tampa, Florida, United States, 33607
- CIL #152
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Tampa, Florida, United States, 33634
- CIL #144
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Georgia
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Newnan, Georgia, United States, 30263
- CIL #116
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Savannah, Georgia, United States, 31406
- CIL #143
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Indiana
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New Albany, Indiana, United States, 47150
- CIL #175
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Kansas
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Overland Park, Kansas, United States, 66215
- CIL #191
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Kentucky
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Louisville, Kentucky, United States, 40217
- CIL #228
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Richmond, Kentucky, United States, 40475
- CIL #194
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Louisiana
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Monroe, Louisiana, United States, 71203
- CIL #219
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Massachusetts
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Boston, Massachusetts, United States, 02114
- CIL #145
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Michigan
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Bay City, Michigan, United States, 48706
- CIL #155
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Missouri
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Saint Louis, Missouri, United States, 63141
- CIL #220
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Nebraska
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Norfolk, Nebraska, United States, 68701
- CIL #148
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Omaha, Nebraska, United States, 68144
- CIL #206
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New Jersey
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Morristown, New Jersey, United States, 07962
- CIL #202
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New York
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New York, New York, United States, 10024
- CIL #197
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North Carolina
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Charlotte, North Carolina, United States, 28277
- CIL #196
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Raleigh, North Carolina, United States, 27612
- CIL #192
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Salisbury, North Carolina, United States, 28144
- CIL #221
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Ohio
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Cincinnati, Ohio, United States, 45246
- CIL #169
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Oregon
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Gresham, Oregon, United States, 97030
- CIL #237
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Pennsylvania
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Broomall, Pennsylvania, United States, 19008
- CIL #137
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Hershey, Pennsylvania, United States, 17033
- CIL #147
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Philadelphia, Pennsylvania, United States, 19103
- CIL #178
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Texas
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Austin, Texas, United States, 78735
- CIL #160
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Austin, Texas, United States, 78759
- CIL #183
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Bryan, Texas, United States, 77802
- CIL #184
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Channelview, Texas, United States, 77530
- CIL #163
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Dallas, Texas, United States, 75230
- CIL #165
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Houston, Texas, United States, 77030
- CIL #167
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Plano, Texas, United States, 75024
- CIL #223
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San Antonio, Texas, United States, 78229
- CIL #159
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Virginia
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Lynchburg, Virginia, United States, 24501
- CIL #105
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Norfolk, Virginia, United States, 23507
- CIL #231
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 99 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Moderate to severe acne
- Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones) on the face
- Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)
Exclusion Criteria:
- Women of child-bearing potential who are pregnant, nursing, considering becoming pregnant
- Any dermatologic condition that could interfere with clinical evaluations including severe, recalcitrant cystic acne
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SB204 4%
SB204 4% topically once daily
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Applied topically once daily
Other Names:
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Placebo Comparator: Vehicle Gel
Vehicle Gel topically once daily
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Applied topically one daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute Change From Baseline in Inflammatory Lesion Counts
Time Frame: Baseline and Week 12
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The absolute change from Baseline in inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose).
Inflammatory lesions included papules, pustules, nodules, and cysts.
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Baseline and Week 12
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Absolute Change From Baseline in Non-inflammatory Lesion Counts
Time Frame: Baseline and Week 12
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The absolute change from Baseline in non-inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose).
Non-inflammatory lesions included open comedones (blackheads) and closed comedones (whiteheads).
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Baseline and Week 12
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Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12
Time Frame: Week 12
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Proportion of subjects with Investigator Global Assessment (IGA) Success at Week 12 is defined as an IGA score of 0 or 1 (Clear/Almost Clear) and at least a 2 grade improvement from Baseline. The IGA scale is as follows: Grade Description 0 Clear: Clear skin with no inflammatory or non-inflammatory lesions.
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Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in Inflammatory Lesion Count
Time Frame: Baseline and Week 12
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The percent change from baseline in inflammatory lesion count
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Baseline and Week 12
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Percent Change in Non-inflammatory Lesion Count
Time Frame: Baseline and Week 12
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The percent change from baseline in non-inflammatory lesion count
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Baseline and Week 12
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Time to Reduction in Inflammatory Lesion Count
Time Frame: Week 12
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Median time to a 35% reduction (improvement) in inflammatory lesion count (Kaplan-Meier analysis)
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Week 12
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Time to Improvement in IGA
Time Frame: Week 12
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Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis)
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Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Joyce Rico, MD, Novan, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 19, 2016
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 9, 2016
Study Registration Dates
First Submitted
January 26, 2016
First Submitted That Met QC Criteria
January 26, 2016
First Posted (Estimated)
January 29, 2016
Study Record Updates
Last Update Posted (Estimated)
July 24, 2023
Last Update Submitted That Met QC Criteria
July 12, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NI-AC302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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