Clinical trial NCT02798120: P3 Long Term Safety Study of Once Daily SB204 in Acne
Official title: A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Novan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Chiltern International Inc.
First posted: 2016-06-14
Enrollment: 601
Sex: ALL
Minimum age (years): 9
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open label long-term safety (LTS) study to be conducted in approximately 600 subjects with acne vulgaris.

Detailed description: A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris.

Eligibility criteria: Inclusion Criteria:

* Have completed 12 weeks of treatment in NI-AC301 or NI-AC302

Exclusion Criteria:

* Terminated early from an SB204 Phase 3 pivotal study for any reason
* 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.

Primary outcomes:
measure: Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303)
timeFrame: Baseline
measure: Number of Subjects With Treatment Emergent Adverse Events
timeFrame: Week 40/End of Treatment
Secondary outcomes:
measure: Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
timeFrame: Baseline, Week 4, Week 12, Week 24, Week 36, Week 40
measure: Inflammatory Lesion Counts by Study Visit
timeFrame: Baseline through Week 40
measure: Non-Inflammatory Lesion Counts by Study Visit
timeFrame: Baseline through Week 40
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: CIL #138
state: Alabama
city: Mobile
country: United States
facility: CIL #218
state: Alabama
city: Phoenix
country: United States
facility: CIL #189
state: Arizona
city: Anaheim
country: United States
facility: CIL #146
state: California
city: Cerritos
country: United States
facility: CIL #139
state: California
city: Chula Vista
country: United States
facility: CIL #216
state: California
city: Fresno
country: United States
facility: CIL #186
state: California
city: Fresno
country: United States
facility: CIL #210
state: California
city: Huntington Beach
country: United States
facility: CIL #174
state: California
city: La Mesa
country: United States
facility: CIL #213
state: California
city: Oceanside
country: United States
facility: CIL #209
state: California
city: Sacramento
country: United States
facility: CIL #190
state: California
city: San Diego
country: United States
facility: CIL #161
state: California
city: San Diego
country: United States
facility: CIL #113
state: California
city: Santa Ana
country: United States
facility: CIL #195
state: California
city: Santa Monica
country: United States
facility: CIL #119
state: California
city: Santa Rosa
country: United States
facility: CIL #199
state: California
city: Boca Raton
country: United States
facility: CIL #103
state: Florida
city: Hialeah
country: United States
facility: CIL #208
state: Florida
city: Homestead
country: United States
facility: CIL #212
state: Florida
city: Lauderdale Lakes
country: United States
facility: CIL #222
state: Florida
city: Miami Lakes
country: United States
facility: CIL #170
state: Florida
city: Miami Springs
country: United States
facility: CIL #204
state: Florida
city: Orlando
country: United States
facility: CIL #172
state: Florida
city: Ormond Beach
country: United States
facility: CIL #185
state: Florida
city: Ormond Beach
country: United States
facility: CIL #203
state: Florida
city: Pinellas Park
country: United States
facility: CIL #110
state: Florida
city: Saint Petersburg
country: United States
facility: CIL #176
state: Florida
city: Sanford
country: United States
facility: CIL #227
state: Florida
city: South Miami
country: United States
facility: CIL #211
state: Florida
city: Tampa
country: United States
facility: CIL #152
state: Florida
city: Tampa
country: United States
facility: CIL #229
state: Florida
city: Tampa
country: United States
facility: CIL #144
state: Florida
city: Wellington
country: United States
facility: CIL #153
state: Florida
city: Newnan
country: United States
facility: CIL #116
state: Georgia
city: Savannah
country: United States
facility: CIL #143
state: Georgia
city: New Albany
country: United States
facility: CIL #175
state: Indiana
city: Overland Park
country: United States
facility: CIL #191
state: Kansas
city: Wichita
country: United States
facility: CIL #215
state: Kansas
city: Louisville
country: United States
facility: CIL #117
state: Kentucky
city: Richmond
country: United States
facility: CIL #194
state: Kentucky
city: Monroe
country: United States
facility: CIL #219
state: Louisiana
city: Saint Louis
country: United States
facility: CIL #187
state: Missouri
city: Norfolk
country: United States
facility: CIL #148
state: Nebraska
city: Omaha
country: United States
facility: CIL #140
state: Nebraska
city: Las Vegas
country: United States
facility: CIL #182
state: Nevada
city: Berlin
country: United States
facility: CIL #201
state: New Jersey
city: Montclair
country: United States
facility: CIL #141
state: New Jersey
city: Albuquerque
country: United States
facility: CIL #156
state: New Mexico
city: Rochester
country: United States
facility: CIL #108
state: New York
city: Salisbury
country: United States
facility: CIL #221
state: North Carolina
city: Cincinnati
country: United States
facility: CIL #169
state: Ohio
city: Cincinnati
country: United States
facility: CIL #226
state: Ohio
city: Gresham
country: United States
facility: CIL #237
state: Oregon
city: Portland
country: United States
facility: CIL #200
state: Oregon
city: Broomall
country: United States
facility: CIL #137
state: Pennsylvania
city: Philadelphia
country: United States
facility: CIL #178
state: Pennsylvania
city: Chattanooga
country: United States
facility: CIL #217
state: Tennessee
city: Arlington
country: United States
facility: CIL #198
state: Texas
city: Austin
country: United States
facility: CIL #160
state: Texas
city: Beaumont
country: United States
facility: CIL #154
state: Texas
city: Bryan
country: United States
facility: CIL #184
state: Texas
city: Houston
country: United States
facility: CIL #188
state: Texas
city: Plano
country: United States
facility: CIL #151
state: Texas
city: Plano
country: United States
facility: CIL #168
state: Texas
city: San Antonio
country: United States
facility: CIL #224
state: Texas
city: Salt Lake City
country: United States
facility: CIL #106
state: Utah
city: Lynchburg
country: United States
facility: CIL #105
state: Virginia
city: Norfolk
country: United States
facility: CIL #231
state: Virginia
Study officials:
affiliation: Novan, Inc.
name: Joyce Rico
role: STUDY_CHAIR
References: