P3 Study in Acne Comparing Once Daily SB204 and Vehicle
NCT ID: NCT02672332
Last Updated: 2023-07-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1307 participants
INTERVENTIONAL
2016-02-22
2016-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SB204 4%
SB204 4% topically once daily
SB204 4%
Once daily
Vehicle Gel
Vehicle Gel topically once daily
Vehicle Gel
Placebo comparator
Interventions
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SB204 4%
Once daily
Vehicle Gel
Placebo comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Any dermatologic condition that could interfere with clinical evaluations including severe, recalcitrant cystic 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, MD
Role: STUDY_CHAIR
Novan, Inc.
Locations
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CIL #146
Anaheim, California, United States
CIL #118
Encinitas, California, United States
CIL #186
Fresno, California, United States
CIL #210
Fresno, California, United States
CIL #209
Oceanside, California, United States
CIL #161
San Diego, California, United States
CIL #113
San Diego, California, United States
CIL #199
Santa Rosa, California, United States
CIL #103
Boca Raton, Florida, United States
CIL #173
Hialeah, Florida, United States
CIL #212
Homestead, Florida, United States
CIL #222
Lauderdale Lakes, Florida, United States
CIL #157
Miami, Florida, United States
CIL #177
North Miami Beach, Florida, United States
CIL #150
Orlando, Florida, United States
CIL #172
Orlando, Florida, United States
CIL #203
Ormond Beach, Florida, United States
CIL #211
South Miami, Florida, United States
CIL #229
Tampa, Florida, United States
CIL #153
Wellington, Florida, United States
Cil # 179
Chicago, Illinois, United States
CIL #215
Wichita, Kansas, United States
CIL #117
Louisville, Kentucky, United States
CIL #180
New Orleans, Louisiana, United States
CIL #205
Glenn Dale, Maryland, United States
CIL #230
Quincy, Massachusetts, United States
CIL #112
Detroit, Michigan, United States
CIL #149
Troy, Michigan, United States
CIL #225
Saint Joseph, Missouri, United States
CIL #187
St Louis, Missouri, 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 #107
New York, New York, United States
CIL #108
Rochester, New York, United States
CIL #104
Stony Brook, New York, United States
CIL #193
High Point, North Carolina, United States
CIL #166
Winston-Salem, North Carolina, United States
CIL #226
Cincinnati, Ohio, United States
CIL #200
Portland, Oregon, United States
CIL #236
Charleston, South Carolina, United States
CIL #217
Chattanooga, Tennessee, United States
CIL #198
Arlington, Texas, United States
CIL #154
Beaumont, Texas, United States
CIL #162
Carrollton, 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 #171
San Antonio, Texas, United States
CIL #164
Sugar Land, Texas, United States
CIL #106
Salt Lake City, Utah, United States
CIL #114
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-AC301
Identifier Type: -
Identifier Source: org_study_id
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