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P3 Study in Acne Comparing Once Daily SB204 and Vehicle

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SB204 4%
Vehicle Gel
Sponsored by
Novan, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

9 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CIL #146
  • CIL #118
  • CIL #186
  • CIL #210
  • CIL #209
  • CIL #161
  • CIL #113
  • CIL #199
  • CIL #103
  • CIL #173
  • CIL #212
  • CIL #222
  • CIL #157
  • CIL #177
  • CIL #150
  • CIL #172
  • CIL #203
  • CIL #211
  • CIL #229
  • CIL #153
  • Cil # 179
  • CIL #215
  • CIL #117
  • CIL #180
  • CIL #205
  • CIL #230
  • CIL #112
  • CIL #149
  • CIL #225
  • CIL #187
  • CIL #140
  • CIL #182
  • CIL #201
  • CIL #141
  • CIL #156
  • CIL #107
  • CIL #108
  • CIL #104
  • CIL #193
  • CIL #166
  • CIL #226
  • CIL #200
  • CIL #236
  • CIL #217
  • CIL #198
  • CIL #154
  • CIL #162
  • CIL #188
  • CIL #151
  • CIL #168
  • CIL #224
  • CIL #171
  • CIL #164
  • CIL #106
  • CIL #114

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SB204 4%

Vehicle Gel

Arm Description

SB204 4% topically once daily

Vehicle Gel topically once daily

Outcomes

Primary Outcome Measures

Absolute Change From Baseline in Inflammatory Lesion Counts
The absolute change from Baseline in inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Inflammatory lesions included papules, pustules, nodules, and cysts.
Absolute Change From Baseline in Non-inflammatory Lesion Counts
The absolute change from Baseline in non-inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Non-inflammatory lesions included open comedones (blackheads) and closed comedones (whiteheads).
Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12
Proportion of subjects with Investigator Global Assessment (IGA) Success at Week 12 is defined as an IGA score of 0 or 1 (Clear/Almost Clear) and at least a 2 grade improvement from Baseline. The IGA scale is as follows: Grade Description 0 Clear: Clear skin with no inflammatory or non-inflammatory lesions. Almost clear: Rare non-inflammatory lesions with rare papules (papules may be resolving and hyperpigmented, though not pink-red). Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions. Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one nodulocystic lesion. Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodulocystic lesions

Secondary Outcome Measures

Percent Change in Inflammatory Lesion Count
The percent change from baseline in inflammatory lesion count
Percent Change in Non-inflammatory Lesion Count
The percent change from baseline in non-inflammatory lesion count
Time to Reduction in Inflammatory Lesion Counts
Median time to a 35% reduction in inflammatory lesion count (Kaplan-Meier)
Time to Improvement in IGA
Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis).

Full Information

First Posted
February 1, 2016
Last Updated
July 12, 2023
Sponsor
Novan, Inc.
Collaborators
Chiltern International Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02672332
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 21, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novan, Inc.
Collaborators
Chiltern International Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1307 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SB204 4%
Arm Type
Experimental
Arm Description
SB204 4% topically once daily
Arm Title
Vehicle Gel
Arm Type
Placebo Comparator
Arm Description
Vehicle Gel topically once daily
Intervention Type
Drug
Intervention Name(s)
SB204 4%
Other Intervention Name(s)
NVN1000
Intervention Description
Once daily
Intervention Type
Drug
Intervention Name(s)
Vehicle Gel
Other Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in Inflammatory Lesion Counts
Description
The absolute change from Baseline in inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Inflammatory lesions included papules, pustules, nodules, and cysts.
Time Frame
Baseline and Week 12
Title
Absolute Change From Baseline in Non-inflammatory Lesion Counts
Description
The absolute change from Baseline in non-inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Non-inflammatory lesions included open comedones (blackheads) and closed comedones (whiteheads).
Time Frame
Baseline and Week 12
Title
Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12
Description
Proportion of subjects with Investigator Global Assessment (IGA) Success at Week 12 is defined as an IGA score of 0 or 1 (Clear/Almost Clear) and at least a 2 grade improvement from Baseline. The IGA scale is as follows: Grade Description 0 Clear: Clear skin with no inflammatory or non-inflammatory lesions. Almost clear: Rare non-inflammatory lesions with rare papules (papules may be resolving and hyperpigmented, though not pink-red). Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions. Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one nodulocystic lesion. Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodulocystic lesions
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Percent Change in Inflammatory Lesion Count
Description
The percent change from baseline in inflammatory lesion count
Time Frame
Baseline and Week 12
Title
Percent Change in Non-inflammatory Lesion Count
Description
The percent change from baseline in non-inflammatory lesion count
Time Frame
Baseline and Week 12
Title
Time to Reduction in Inflammatory Lesion Counts
Description
Median time to a 35% reduction in inflammatory lesion count (Kaplan-Meier)
Time Frame
Week 12
Title
Time to Improvement in IGA
Description
Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis).
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce Rico, MD
Organizational Affiliation
Novan, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
CIL #146
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
CIL #118
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
CIL #186
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
CIL #210
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
CIL #209
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
CIL #161
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
CIL #113
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
CIL #199
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
CIL #103
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
CIL #173
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
CIL #212
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
CIL #222
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Facility Name
CIL #157
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
CIL #177
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
CIL #150
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
CIL #172
City
Orlando
State/Province
Florida
ZIP/Postal Code
32814
Country
United States
Facility Name
CIL #203
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
CIL #211
City
South Miami
State/Province
Florida
ZIP/Postal Code
33413
Country
United States
Facility Name
CIL #229
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
CIL #153
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Cil # 179
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
CIL #215
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
CIL #117
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
CIL #180
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
CIL #205
City
Glenn Dale
State/Province
Maryland
ZIP/Postal Code
20769
Country
United States
Facility Name
CIL #230
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
CIL #112
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48183
Country
United States
Facility Name
CIL #149
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
CIL #225
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
CIL #187
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
CIL #140
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
CIL #182
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89129
Country
United States
Facility Name
CIL #201
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
CIL #141
City
Montclair
State/Province
New Jersey
ZIP/Postal Code
07042
Country
United States
Facility Name
CIL #156
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
CIL #107
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
CIL #108
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
CIL #104
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
CIL #193
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
CIL #166
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
CIL #226
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45255
Country
United States
Facility Name
CIL #200
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
CIL #236
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
CIL #217
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
CIL #198
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
CIL #154
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
CIL #162
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
CIL #188
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
CIL #151
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
CIL #168
City
Plano
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
CIL #224
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
CIL #171
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
CIL #164
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
CIL #106
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
CIL #114
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.acnetrials.com
Description
Study specific web site

Learn more about this trial

P3 Study in Acne Comparing Once Daily SB204 and Vehicle

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