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P3 Long Term Safety Study of Once Daily SB204 in Acne

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SB204 4%
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:

  • Have completed 12 weeks of treatment in NI-AC301 or NI-AC302

Exclusion Criteria:

  • Terminated early from an SB204 Phase 3 pivotal study for any reason
  • Have an on-going adverse event at Week 12 visit for NI-AC301 or NI-AC302 that warrants stopping study drug application
  • Have used medications or vitamins during the 12 weeks immediately preceding this study which were reported to exacerbate acne.

Sites / Locations

  • CIL #138
  • CIL #218
  • CIL #189
  • CIL #146
  • CIL #139
  • CIL #216
  • CIL #186
  • CIL #210
  • CIL #174
  • CIL #213
  • CIL #209
  • CIL #190
  • CIL #161
  • CIL #113
  • CIL #195
  • CIL #119
  • CIL #199
  • CIL #103
  • CIL #208
  • CIL #212
  • CIL #222
  • CIL #170
  • CIL #204
  • CIL #172
  • CIL #185
  • CIL #203
  • CIL #110
  • CIL #176
  • CIL #227
  • CIL #211
  • CIL #152
  • CIL #229
  • CIL #144
  • CIL #153
  • CIL #116
  • CIL #143
  • CIL #175
  • CIL #191
  • CIL #215
  • CIL #117
  • CIL #194
  • CIL #219
  • CIL #187
  • CIL #148
  • CIL #140
  • CIL #182
  • CIL #201
  • CIL #141
  • CIL #156
  • CIL #108
  • CIL #221
  • CIL #169
  • CIL #226
  • CIL #237
  • CIL #200
  • CIL #137
  • CIL #178
  • CIL #217
  • CIL #198
  • CIL #160
  • CIL #154
  • CIL #184
  • CIL #188
  • CIL #151
  • CIL #168
  • CIL #224
  • CIL #106
  • CIL #105
  • CIL #231

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SB204 4%

Arm Description

All subjects received SB204 4% once daily (QD) in this open label study. Subjects assigned to SB204 4% QD in the parent study (NI-AC301/302) continued to receive SB204 for 40 more weeks. Subjects assigned to Vehicle Gel in the parent study (NI-AC301/302) received SB204 4% QD in this open label study.

Outcomes

Primary Outcome Measures

Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303)
This outcome measure shows the number of subjects with at least one ongoing adverse event from the pivotal studies (NI-AC301 and NI-AC302) at the time they rolled over into this study (NI-AC303). The final study visit (Week 12) for the pivotal studies served as the Baseline visit for this study. Subjects who were assigned to SB204 in the pivotal studies are denoted as SB204 Experienced and subjects who were assigned to Vehicle Gel on the pivotal studies are denoted as SB204 Naive.
Number of Subjects With Treatment Emergent Adverse Events
Number of subjects with adverse events that had an onset date on or after entry into study NI-AC303.

Secondary Outcome Measures

Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Analysis of cutaneous tolerability scores at each visit through end of treatment. Baseline is the Week 12 assessment from the previous study (NI-AC301 or NI-AC302). The Cutaneous Tolerability Assessment scale consisted of the investigator's assessment of erythema, scaling, and dryness at the time the assessment was made. Pruritus and burning/stinging were based on the subject's report for the previous 24 hours. Each component was graded on a scale of 0-3, with 0 being none (not present) and 3 being severe. Higher scores indicated a higher severity of reaction.
Inflammatory Lesion Counts by Study Visit
Absolute count of inflammatory lesions at each visit (face only)--safety population
Non-Inflammatory Lesion Counts by Study Visit
Absolute count of non-inflammatory lesions by study visit (face only)

Full Information

First Posted
June 9, 2016
Last Updated
May 10, 2023
Sponsor
Novan, Inc.
Collaborators
Chiltern International Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02798120
Brief Title
P3 Long Term Safety Study of Once Daily SB204 in Acne
Official Title
A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 12, 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 27, 2017 (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 multi-center, open label long-term safety (LTS) study to be conducted in approximately 600 subjects with acne vulgaris.
Detailed Description
A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
601 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SB204 4%
Arm Type
Experimental
Arm Description
All subjects received SB204 4% once daily (QD) in this open label study. Subjects assigned to SB204 4% QD in the parent study (NI-AC301/302) continued to receive SB204 for 40 more weeks. Subjects assigned to Vehicle Gel in the parent study (NI-AC301/302) received SB204 4% QD in this open label study.
Intervention Type
Drug
Intervention Name(s)
SB204 4%
Other Intervention Name(s)
NVN1000
Intervention Description
Open label, topical SB204 4%
Primary Outcome Measure Information:
Title
Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303)
Description
This outcome measure shows the number of subjects with at least one ongoing adverse event from the pivotal studies (NI-AC301 and NI-AC302) at the time they rolled over into this study (NI-AC303). The final study visit (Week 12) for the pivotal studies served as the Baseline visit for this study. Subjects who were assigned to SB204 in the pivotal studies are denoted as SB204 Experienced and subjects who were assigned to Vehicle Gel on the pivotal studies are denoted as SB204 Naive.
Time Frame
Baseline
Title
Number of Subjects With Treatment Emergent Adverse Events
Description
Number of subjects with adverse events that had an onset date on or after entry into study NI-AC303.
Time Frame
Week 40/End of Treatment
Secondary Outcome Measure Information:
Title
Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)
Description
Analysis of cutaneous tolerability scores at each visit through end of treatment. Baseline is the Week 12 assessment from the previous study (NI-AC301 or NI-AC302). The Cutaneous Tolerability Assessment scale consisted of the investigator's assessment of erythema, scaling, and dryness at the time the assessment was made. Pruritus and burning/stinging were based on the subject's report for the previous 24 hours. Each component was graded on a scale of 0-3, with 0 being none (not present) and 3 being severe. Higher scores indicated a higher severity of reaction.
Time Frame
Baseline, Week 4, Week 12, Week 24, Week 36, Week 40
Title
Inflammatory Lesion Counts by Study Visit
Description
Absolute count of inflammatory lesions at each visit (face only)--safety population
Time Frame
Baseline through Week 40
Title
Non-Inflammatory Lesion Counts by Study Visit
Description
Absolute count of non-inflammatory lesions by study visit (face only)
Time Frame
Baseline through Week 40

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: Have completed 12 weeks of treatment in NI-AC301 or NI-AC302 Exclusion Criteria: Terminated early from an SB204 Phase 3 pivotal study for any reason Have an on-going adverse event at Week 12 visit for NI-AC301 or NI-AC302 that warrants stopping study drug application Have used medications or vitamins during the 12 weeks immediately preceding this study which were reported to exacerbate acne.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce Rico
Organizational Affiliation
Novan, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
CIL #138
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35202
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 #146
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
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 #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 #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 #209
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
CIL #190
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
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 #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 #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 #208
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 #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 #172
City
Orlando
State/Province
Florida
ZIP/Postal Code
32814
Country
United States
Facility Name
CIL #185
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
CIL #203
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 #211
City
South Miami
State/Province
Florida
ZIP/Postal Code
33413
Country
United States
Facility Name
CIL #152
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
CIL #229
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
CIL #144
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
CIL #153
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
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 #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 #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 #187
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 #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 #108
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
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 #226
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45255
Country
United States
Facility Name
CIL #237
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
CIL #200
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
CIL #137
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
Facility Name
CIL #178
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
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 #160
City
Austin
State/Province
Texas
ZIP/Postal Code
78735
Country
United States
Facility Name
CIL #154
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
CIL #184
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
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 #106
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
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

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P3 Long Term Safety Study of Once Daily SB204 in Acne

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