Clinical trial NCT02667444: P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne
Official title: A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of Once Daily SB204 and Vehicle Gel 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: 2016-01-29
Enrollment: 1330
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: 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 Count
timeFrame: Week 12
measure: Time to Improvement in IGA
timeFrame: Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: CIL #214
state: Alabama
city: Mobile
country: United States
facility: CIL #218
state: Alabama
city: Phoenix
country: United States
facility: CIL #189
state: Arizona
city: Cerritos
country: United States
facility: CIL #139
state: California
city: Chula Vista
country: United States
facility: CIL #216
state: California
city: Encino
country: United States
facility: CIL #181
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: Sacramento
country: United States
facility: CIL #190
state: California
city: San Diego
country: United States
facility: CIL #111
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: Bradenton
country: United States
facility: CIL #158
state: Florida
city: Hialeah
country: United States
facility: CIL #208
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: Miami
country: United States
facility: CIL #142
state: Florida
city: Ormond Beach
country: United States
facility: CIL #185
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: Tampa
country: United States
facility: CIL #152
state: Florida
city: Tampa
country: United States
facility: CIL #144
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: Louisville
country: United States
facility: CIL #228
state: Kentucky
city: Richmond
country: United States
facility: CIL #194
state: Kentucky
city: Monroe
country: United States
facility: CIL #219
state: Louisiana
city: Boston
country: United States
facility: CIL #145
state: Massachusetts
city: Bay City
country: United States
facility: CIL #155
state: Michigan
city: Saint Louis
country: United States
facility: CIL #220
state: Missouri
city: Norfolk
country: United States
facility: CIL #148
state: Nebraska
city: Omaha
country: United States
facility: CIL #206
state: Nebraska
city: Morristown
country: United States
facility: CIL #202
state: New Jersey
city: New York
country: United States
facility: CIL #197
state: New York
city: Charlotte
country: United States
facility: CIL #196
state: North Carolina
city: Raleigh
country: United States
facility: CIL #192
state: North Carolina
city: Salisbury
country: United States
facility: CIL #221
state: North Carolina
city: Cincinnati
country: United States
facility: CIL #169
state: Ohio
city: Gresham
country: United States
facility: CIL #237
state: Oregon
city: Broomall
country: United States
facility: CIL #137
state: Pennsylvania
city: Hershey
country: United States
facility: CIL #147
state: Pennsylvania
city: Philadelphia
country: United States
facility: CIL #178
state: Pennsylvania
city: Austin
country: United States
facility: CIL #160
state: Texas
city: Austin
country: United States
facility: CIL #183
state: Texas
city: Bryan
country: United States
facility: CIL #184
state: Texas
city: Channelview
country: United States
facility: CIL #163
state: Texas
city: Dallas
country: United States
facility: CIL #165
state: Texas
city: Houston
country: United States
facility: CIL #167
state: Texas
city: Plano
country: United States
facility: CIL #223
state: Texas
city: San Antonio
country: United States
facility: CIL #159
state: Texas
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, MD
role: STUDY_CHAIR
References: