Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
601 participants
INTERVENTIONAL
2016-05-12
2017-04-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SB204 4%
All subjects received SB204 4% once daily (QD) in this open label study. Subjects assigned to SB204 4% QD in the parent study (NI-AC301/302) continued to receive SB204 for 40 more weeks. Subjects assigned to Vehicle Gel in the parent study (NI-AC301/302) received SB204 4% QD in this open label study.
SB204 4%
Open label, topical SB204 4%
Interventions
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SB204 4%
Open label, topical SB204 4%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Have an on-going adverse event at Week 12 visit for NI-AC301 or NI-AC302 that warrants stopping study drug application
* Have used medications or vitamins during the 12 weeks immediately preceding this study which were reported to exacerbate acne.
9 Years
99 Years
ALL
No
Sponsors
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Chiltern International Inc.
INDUSTRY
Novan, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joyce Rico
Role: STUDY_CHAIR
Novan, Inc.
Locations
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CIL #138
Birmingham, Alabama, United States
CIL #218
Mobile, Alabama, United States
CIL #189
Phoenix, Arizona, United States
CIL #146
Anaheim, California, United States
CIL #139
Cerritos, California, United States
CIL #216
Chula Vista, California, United States
CIL #186
Fresno, California, United States
CIL #210
Fresno, California, United States
CIL #174
Huntington Beach, California, United States
CIL #213
La Mesa, California, United States
CIL #209
Oceanside, California, United States
CIL #190
Sacramento, California, United States
CIL #161
San Diego, California, United States
CIL #113
San Diego, California, United States
CIL #195
Santa Ana, California, United States
CIL #119
Santa Monica, California, United States
CIL #199
Santa Rosa, California, United States
CIL #103
Boca Raton, Florida, United States
CIL #208
Hialeah, Florida, United States
CIL #212
Homestead, Florida, United States
CIL #222
Lauderdale Lakes, Florida, United States
CIL #170
Miami Lakes, Florida, United States
CIL #204
Miami Springs, Florida, United States
CIL #172
Orlando, Florida, United States
CIL #185
Ormond Beach, Florida, United States
CIL #203
Ormond Beach, Florida, United States
CIL #110
Pinellas Park, Florida, United States
CIL #227
Sanford, Florida, United States
CIL #211
South Miami, Florida, United States
CIL #176
St. Petersburg, Florida, United States
CIL #152
Tampa, Florida, United States
CIL #229
Tampa, Florida, United States
CIL #144
Tampa, Florida, United States
CIL #153
Wellington, Florida, United States
CIL #116
Newnan, Georgia, United States
CIL #143
Savannah, Georgia, United States
CIL #175
New Albany, Indiana, United States
CIL #191
Overland Park, Kansas, United States
CIL #215
Wichita, Kansas, United States
CIL #117
Louisville, Kentucky, United States
CIL #194
Richmond, Kentucky, United States
CIL #219
Monroe, Louisiana, United States
CIL #187
St Louis, Missouri, United States
CIL #148
Norfolk, Nebraska, United States
CIL #140
Omaha, Nebraska, United States
CIL #182
Las Vegas, Nevada, United States
CIL #201
Berlin, New Jersey, United States
CIL #141
Montclair, New Jersey, United States
CIL #156
Albuquerque, New Mexico, United States
CIL #108
Rochester, New York, United States
CIL #221
Salisbury, North Carolina, United States
CIL #169
Cincinnati, Ohio, United States
CIL #226
Cincinnati, Ohio, United States
CIL #237
Gresham, Oregon, United States
CIL #200
Portland, Oregon, United States
CIL #137
Broomall, Pennsylvania, United States
CIL #178
Philadelphia, Pennsylvania, United States
CIL #217
Chattanooga, Tennessee, United States
CIL #198
Arlington, Texas, United States
CIL #160
Austin, Texas, United States
CIL #154
Beaumont, Texas, United States
CIL #184
Bryan, Texas, United States
CIL #188
Houston, Texas, United States
CIL #151
Plano, Texas, United States
CIL #168
Plano, Texas, United States
CIL #224
San Antonio, Texas, United States
CIL #106
Salt Lake City, Utah, United States
CIL #105
Lynchburg, Virginia, United States
CIL #231
Norfolk, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NI-AC303
Identifier Type: -
Identifier Source: org_study_id
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