Clinical trial NCT02242760: P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris
Official title: A Phase 2, Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled Study Comparing the Efficacy, Tolerability, and Safety of SB204 Gel and Vehicle Gel Once or Twice Daily in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: acne
Lead sponsor: Novan, Inc.
Sponsor class: INDUSTRY
First posted: 2014-09-17
Enrollment: 213
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.

Detailed description: A randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Moderate to severe acne
* 25-70 non-inflammatory lesions at Baseline
* 20-40 inflammatory lesions at Baseline

Exclusion Criteria:

* Subjects with known allergy to any component of the test material or vehicle
* Women who are pregnant or nursing

Primary outcomes:
measure: Absolute Change in Inflammatory Lesion Counts
timeFrame: Baseline and Week 12
measure: Absolute Change in Non-inflammatory Lesion Counts
timeFrame: Baseline and Week 12
measure: Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Percent Change in Inflammatory Lesion Count From Baseline to Week 12
timeFrame: Baseline and Week 12
measure: Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12
timeFrame: Baseline and Week 12
measure: Median Time to Improvement
timeFrame: Baseline through Week 12
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Qst acne site #1
state: Arkansas
city: Encinitas
country: United States
facility: QST Site #118
state: California
city: San Diego
country: United States
facility: QST Site #111
state: California
city: San Diego
country: United States
facility: QST Site #113
state: California
city: Santa Monica
country: United States
facility: QST Site #119
state: California
city: Boca Raton
country: United States
facility: QST Site #103
state: Florida
city: Pinellas Park
country: United States
facility: QST Site # 110
state: Florida
city: Newnan
country: United States
facility: QST Site # 116
state: Georgia
city: Louisville
country: United States
facility: QST Site #117
state: Kentucky
city: Detroit
country: United States
facility: QST Site #112
state: Michigan
city: Warren
country: United States
facility: QST Site #120
state: Michigan
city: Minneapolis
country: United States
facility: QST Site # 121
state: Minnesota
city: New York
country: United States
facility: QST Site #107
state: New York
city: Rochester
country: United States
facility: QST Site #108
state: New York
city: Rochester
country: United States
facility: QST Site #109
state: New York
city: Stony Brook
country: United States
facility: QST Site #104
state: New York
city: San Antonio
country: United States
facility: QST Site # 102
state: Texas
city: Salt Lake City
country: United States
facility: QST Site #106
state: Utah
city: Lynchburg
country: United States
facility: QST #105
state: Virginia
city: Norfolk
country: United States
facility: QST Site #114
state: Virginia
Study officials:
affiliation: Novan, Inc.
name: M J Rico, MD
role: STUDY_DIRECTOR
References: