Clinical trial NCT02672332: P3 Study in Acne Comparing Once Daily SB204 and Vehicle
Official title: A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of SB204 and Vehicle Gel 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: 2016-02-03
Enrollment: 1307
Sex: ALL
Minimum age (years): 9
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Absolute Change From Baseline in Inflammatory Lesion Counts
timeFrame: Baseline and Week 12
measure: Absolute Change From Baseline in Non-inflammatory Lesion Counts
timeFrame: Baseline and Week 12
measure: Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Percent Change in Inflammatory Lesion Count
timeFrame: Baseline and Week 12
measure: Percent Change in Non-inflammatory Lesion Count
timeFrame: Baseline and Week 12
measure: Time to Reduction in Inflammatory Lesion Counts
timeFrame: Week 12
measure: Time to Improvement in IGA
timeFrame: Week 12
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: CIL #146
state: California
city: Encinitas
country: United States
facility: CIL #118
state: California
city: Fresno
country: United States
facility: CIL #186
state: California
city: Fresno
country: United States
facility: CIL #210
state: California
city: Oceanside
country: United States
facility: CIL #209
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 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 #173
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
country: United States
facility: CIL #157
state: Florida
city: North Miami Beach
country: United States
facility: CIL #177
state: Florida
city: Orlando
country: United States
facility: CIL #150
state: Florida
city: Orlando
country: United States
facility: CIL #172
state: Florida
city: Ormond Beach
country: United States
facility: CIL #203
state: Florida
city: South Miami
country: United States
facility: CIL #211
state: Florida
city: Tampa
country: United States
facility: CIL #229
state: Florida
city: Wellington
country: United States
facility: CIL #153
state: Florida
city: Chicago
country: United States
facility: Cil # 179
state: Illinois
city: Wichita
country: United States
facility: CIL #215
state: Kansas
city: Louisville
country: United States
facility: CIL #117
state: Kentucky
city: New Orleans
country: United States
facility: CIL #180
state: Louisiana
city: Glenn Dale
country: United States
facility: CIL #205
state: Maryland
city: Quincy
country: United States
facility: CIL #230
state: Massachusetts
city: Detroit
country: United States
facility: CIL #112
state: Michigan
city: Troy
country: United States
facility: CIL #149
state: Michigan
city: Saint Joseph
country: United States
facility: CIL #225
state: Missouri
city: Saint Louis
country: United States
facility: CIL #187
state: Missouri
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: New York
country: United States
facility: CIL #107
state: New York
city: Rochester
country: United States
facility: CIL #108
state: New York
city: Stony Brook
country: United States
facility: CIL #104
state: New York
city: High Point
country: United States
facility: CIL #193
state: North Carolina
city: Winston-Salem
country: United States
facility: CIL #166
state: North Carolina
city: Cincinnati
country: United States
facility: CIL #226
state: Ohio
city: Portland
country: United States
facility: CIL #200
state: Oregon
city: Charleston
country: United States
facility: CIL #236
state: South Carolina
city: Chattanooga
country: United States
facility: CIL #217
state: Tennessee
city: Arlington
country: United States
facility: CIL #198
state: Texas
city: Beaumont
country: United States
facility: CIL #154
state: Texas
city: Carrollton
country: United States
facility: CIL #162
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: San Antonio
country: United States
facility: CIL #171
state: Texas
city: Sugar Land
country: United States
facility: CIL #164
state: Texas
city: Salt Lake City
country: United States
facility: CIL #106
state: Utah
city: Norfolk
country: United States
facility: CIL #114
state: Virginia
Study officials:
affiliation: Novan, Inc.
name: Joyce Rico, MD
role: STUDY_CHAIR
References: