search
Back to results

P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne

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 #214
  • CIL #218
  • CIL #189
  • CIL #139
  • CIL #216
  • CIL #181
  • CIL #174
  • CIL #213
  • CIL #190
  • CIL #111
  • CIL #195
  • CIL #119
  • CIL #158
  • CIL #208
  • CIL #170
  • CIL #204
  • CIL #142
  • CIL #185
  • CIL #110
  • CIL #176
  • CIL #227
  • CIL #152
  • CIL #144
  • CIL #116
  • CIL #143
  • CIL #175
  • CIL #191
  • CIL #228
  • CIL #194
  • CIL #219
  • CIL #145
  • CIL #155
  • CIL #220
  • CIL #148
  • CIL #206
  • CIL #202
  • CIL #197
  • CIL #196
  • CIL #192
  • CIL #221
  • CIL #169
  • CIL #237
  • CIL #137
  • CIL #147
  • CIL #178
  • CIL #160
  • CIL #183
  • CIL #184
  • CIL #163
  • CIL #165
  • CIL #167
  • CIL #223
  • CIL #159
  • CIL #105
  • CIL #231

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 Count
Median time to a 35% reduction (improvement) in inflammatory lesion count (Kaplan-Meier analysis)
Time to Improvement in IGA
Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis)

Full Information

First Posted
January 26, 2016
Last Updated
July 12, 2023
Sponsor
Novan, Inc.
Collaborators
Chiltern International Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02667444
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 19, 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 9, 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
1330 (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
Applied topically once daily
Intervention Type
Drug
Intervention Name(s)
Vehicle Gel
Other Intervention Name(s)
Placebo
Intervention Description
Applied topically one daily
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
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 Count
Description
Median time to a 35% reduction (improvement) in inflammatory lesion count (Kaplan-Meier analysis)
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 #214
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
CIL #218
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
CIL #189
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
CIL #139
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
CIL #216
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
CIL #181
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
CIL #174
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
CIL #213
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
CIL #190
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
CIL #111
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
CIL #195
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
CIL #119
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
CIL #158
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
CIL #208
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
CIL #170
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
CIL #204
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
CIL #142
City
Miami
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
CIL #185
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
CIL #110
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
CIL #176
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33716
Country
United States
Facility Name
CIL #227
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
CIL #152
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
CIL #144
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
CIL #116
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
CIL #143
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
CIL #175
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
CIL #191
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
CIL #228
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
CIL #194
City
Richmond
State/Province
Kentucky
ZIP/Postal Code
40475
Country
United States
Facility Name
CIL #219
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
CIL #145
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
CIL #155
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
CIL #220
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
CIL #148
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
CIL #206
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
CIL #202
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
CIL #197
City
New York
State/Province
New York
ZIP/Postal Code
10024
Country
United States
Facility Name
CIL #196
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
CIL #192
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
CIL #221
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
CIL #169
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
CIL #237
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
CIL #137
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
Facility Name
CIL #147
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
CIL #178
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
CIL #160
City
Austin
State/Province
Texas
ZIP/Postal Code
78735
Country
United States
Facility Name
CIL #183
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
CIL #184
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
CIL #163
City
Channelview
State/Province
Texas
ZIP/Postal Code
77530
Country
United States
Facility Name
CIL #165
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
CIL #167
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
CIL #223
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
CIL #159
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
CIL #105
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
CIL #231
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
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 Comparing Once Daily SB204 and Vehicle Gel in Acne

We'll reach out to this number within 24 hrs