P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne
NCT ID: NCT02667444
Last Updated: 2023-07-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1330 participants
INTERVENTIONAL
2016-02-19
2016-12-09
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%
Applied topically once daily
Vehicle Gel
Vehicle Gel topically once daily
Vehicle Gel
Applied topically one daily
Interventions
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SB204 4%
Applied topically once daily
Vehicle Gel
Applied topically one daily
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 #214
Birmingham, Alabama, United States
CIL #218
Mobile, Alabama, United States
CIL #189
Phoenix, Arizona, United States
CIL #139
Cerritos, California, United States
CIL #216
Chula Vista, California, United States
CIL #181
Encino, California, United States
CIL #174
Huntington Beach, California, United States
CIL #213
La Mesa, California, United States
CIL #190
Sacramento, California, United States
CIL #111
San Diego, California, United States
CIL #195
Santa Ana, California, United States
CIL #119
Santa Monica, California, United States
CIL #158
Bradenton, Florida, United States
CIL #208
Hialeah, Florida, United States
CIL #142
Miami, Florida, United States
CIL #170
Miami Lakes, Florida, United States
CIL #204
Miami Springs, Florida, United States
CIL #185
Ormond Beach, Florida, United States
CIL #110
Pinellas Park, Florida, United States
CIL #227
Sanford, Florida, United States
CIL #176
St. Petersburg, Florida, United States
CIL #152
Tampa, Florida, United States
CIL #144
Tampa, 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 #228
Louisville, Kentucky, United States
CIL #194
Richmond, Kentucky, United States
CIL #219
Monroe, Louisiana, United States
CIL #145
Boston, Massachusetts, United States
CIL #155
Bay City, Michigan, United States
CIL #220
St Louis, Missouri, United States
CIL #148
Norfolk, Nebraska, United States
CIL #206
Omaha, Nebraska, United States
CIL #202
Morristown, New Jersey, United States
CIL #197
New York, New York, United States
CIL #196
Charlotte, North Carolina, United States
CIL #192
Raleigh, North Carolina, United States
CIL #221
Salisbury, North Carolina, United States
CIL #169
Cincinnati, Ohio, United States
CIL #237
Gresham, Oregon, United States
CIL #137
Broomall, Pennsylvania, United States
CIL #147
Hershey, Pennsylvania, United States
CIL #178
Philadelphia, Pennsylvania, United States
CIL #160
Austin, Texas, United States
CIL #183
Austin, Texas, United States
CIL #184
Bryan, Texas, United States
CIL #163
Channelview, Texas, United States
CIL #165
Dallas, Texas, United States
CIL #167
Houston, Texas, United States
CIL #223
Plano, Texas, United States
CIL #159
San Antonio, Texas, 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-AC302
Identifier Type: -
Identifier Source: org_study_id
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