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P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SB204 2%
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 focused on measuring acne

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Qst acne site #1
  • QST Site #118
  • QST Site #111
  • QST Site #113
  • QST Site #119
  • QST Site #103
  • QST Site # 110
  • QST Site # 116
  • QST Site #117
  • QST Site #112
  • QST Site #120
  • QST Site # 121
  • QST Site #107
  • QST Site #108
  • QST Site #109
  • QST Site #104
  • QST Site # 102
  • QST Site #106
  • QST #105
  • QST Site #114

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Experimental

Arm Label

SB204 2% Twice daily

SB204 4% daily

Vehicle Gel Daily

Vehicle Gel Twice Daily

SB204 4% Twice Daily

Arm Description

Twice daily SB204 2%

Once daily SB204 4%

Vehicle Gel Daily

Twice daily Vehicle Gel

Twice daily SB204 4%

Outcomes

Primary Outcome Measures

Absolute Change in Inflammatory Lesion Counts
Change in inflammatory lesion count from Baseline to Week 12
Absolute Change in Non-inflammatory Lesion Counts
Absolute Change in non-inflammatory lesion count from Baseline to Week 12
Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment
Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome. Grade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions)

Secondary Outcome Measures

Percent Change in Inflammatory Lesion Count From Baseline to Week 12
The percent change in inflammatory lesion count from Baseline to Week 12
Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12
The percent change in non-inflammatory lesion count from Baseline to Week 12
Median Time to Improvement
Median time to a 35% improvement in inflammatory lesion counts (Kaplan-Meier estimate). The full range values presented below are estimates made from the Kaplan-Meier figure.

Full Information

First Posted
September 10, 2014
Last Updated
May 26, 2023
Sponsor
Novan, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02242760
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SB204 2% Twice daily
Arm Type
Experimental
Arm Description
Twice daily SB204 2%
Arm Title
SB204 4% daily
Arm Type
Experimental
Arm Description
Once daily SB204 4%
Arm Title
Vehicle Gel Daily
Arm Type
Placebo Comparator
Arm Description
Vehicle Gel Daily
Arm Title
Vehicle Gel Twice Daily
Arm Type
Placebo Comparator
Arm Description
Twice daily Vehicle Gel
Arm Title
SB204 4% Twice Daily
Arm Type
Experimental
Arm Description
Twice daily SB204 4%
Intervention Type
Drug
Intervention Name(s)
SB204 2%
Other Intervention Name(s)
NVN1000
Intervention Description
Applied topically twice daily
Intervention Type
Drug
Intervention Name(s)
SB204 4%
Other Intervention Name(s)
NVN1000
Intervention Description
Applied topically daily
Intervention Type
Drug
Intervention Name(s)
Vehicle Gel
Other Intervention Name(s)
Placeco
Intervention Description
Applied topically twice and once daily
Primary Outcome Measure Information:
Title
Absolute Change in Inflammatory Lesion Counts
Description
Change in inflammatory lesion count from Baseline to Week 12
Time Frame
Baseline and Week 12
Title
Absolute Change in Non-inflammatory Lesion Counts
Description
Absolute Change in non-inflammatory lesion count from Baseline to Week 12
Time Frame
Baseline and Week 12
Title
Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment
Description
Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome. Grade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions)
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Percent Change in Inflammatory Lesion Count From Baseline to Week 12
Description
The percent change in inflammatory lesion count from Baseline to Week 12
Time Frame
Baseline and Week 12
Title
Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12
Description
The percent change in non-inflammatory lesion count from Baseline to Week 12
Time Frame
Baseline and Week 12
Title
Median Time to Improvement
Description
Median time to a 35% improvement in inflammatory lesion counts (Kaplan-Meier estimate). The full range values presented below are estimates made from the Kaplan-Meier figure.
Time Frame
Baseline through Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M J Rico, MD
Organizational Affiliation
Novan, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Qst acne site #1
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
QST Site #118
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
QST Site #111
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
QST Site #113
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
QST Site #119
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
QST Site #103
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
QST Site # 110
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
QST Site # 116
City
Newnan
State/Province
Georgia
ZIP/Postal Code
302636
Country
United States
Facility Name
QST Site #117
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
QST Site #112
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
QST Site #120
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
QST Site # 121
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
QST Site #107
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
QST Site #108
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
QST Site #109
City
Rochester
State/Province
New York
ZIP/Postal Code
14625
Country
United States
Facility Name
QST Site #104
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
QST Site # 102
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
QST Site #106
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
QST #105
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
QST Site #114
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Learn more about this trial

P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris

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