P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne

Phase 3

Completed

Conditions: Acne Vulgaris

Interventions: Drug: SB204 4%
Drug: Vehicle Gel

Registration Number: NCT02667444

Lead Sponsor: Novan, Inc.

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1330

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SB204 4%	SB204 4%	SB204 4% topically once daily
Vehicle Gel	Vehicle Gel	Vehicle Gel topically once daily

Primary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in Non-inflammatory Lesion Counts	Baseline and Week 12	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).
Absolute Change From Baseline in Inflammatory Lesion Counts	Baseline and Week 12	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.
Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12	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. 1. Almost clear: Rare non-inflammatory lesions with rare papules (papules may be resolving and hyperpigmented, though not pink-red). 2. Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions. 3. Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one nodulocystic lesion. 4. Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodulocystic lesions

Secondary Outcome Measures

Name	Time	Method
Percent Change in Inflammatory Lesion Count	Baseline and Week 12	The percent change from baseline in inflammatory lesion count
Percent Change in Non-inflammatory Lesion Count	Baseline and Week 12	The percent change from baseline in non-inflammatory lesion count
Time to Reduction in Inflammatory Lesion Count	Week 12	Median time to a 35% reduction (improvement) in inflammatory lesion count (Kaplan-Meier analysis)
Time to Improvement in IGA	Week 12	Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis)

Trial Locations

Locations (55): CIL #142
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Miami, Florida, United States
CIL #111
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San Diego, California, United States
CIL #191
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Overland Park, Kansas, United States
CIL #218
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Mobile, Alabama, United States
CIL #139
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Cerritos, California, United States
CIL #216
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Chula Vista, California, United States
CIL #181
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Encino, California, United States
CIL #174
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Huntington Beach, California, United States
CIL #119
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Santa Monica, California, United States
CIL #195
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Santa Ana, California, United States
CIL #208
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Hialeah, Florida, United States
CIL #158
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Bradenton, Florida, United States
CIL #170
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Miami Lakes, Florida, United States
CIL #204
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Miami Springs, Florida, United States
CIL #110
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Pinellas Park, Florida, United States
CIL #176
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Saint Petersburg, Florida, United States
CIL #185
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Ormond Beach, Florida, United States
CIL #227
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Sanford, Florida, United States
CIL #116
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Newnan, Georgia, United States
CIL #175
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New Albany, Indiana, United States
CIL #143
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Savannah, Georgia, United States
CIL #219
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Monroe, Louisiana, United States
CIL #194
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Richmond, Kentucky, United States
CIL #155
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Bay City, Michigan, United States
CIL #145
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Boston, Massachusetts, United States
CIL #220
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Saint Louis, Missouri, United States
CIL #148
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Norfolk, Nebraska, United States
CIL #202
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Morristown, New Jersey, United States
CIL #197
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New York, New York, United States
CIL #196
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Charlotte, North Carolina, United States
CIL #169
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Cincinnati, Ohio, United States
CIL #221
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Salisbury, North Carolina, United States
CIL #192
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Raleigh, North Carolina, United States
CIL #237
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Gresham, Oregon, United States
CIL #137
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Broomall, Pennsylvania, United States
CIL #147
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Hershey, Pennsylvania, United States
CIL #178
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Philadelphia, Pennsylvania, United States
CIL #183
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Austin, Texas, United States
CIL #184
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Bryan, Texas, United States
CIL #163
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Channelview, Texas, United States
CIL #165
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Dallas, Texas, United States
CIL #167
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Houston, Texas, United States
CIL #223
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Plano, Texas, United States
CIL #105
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Lynchburg, Virginia, United States
CIL #231
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Norfolk, Virginia, United States
CIL #214
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Birmingham, Alabama, United States
CIL #189
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Phoenix, Arizona, United States
CIL #152
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Tampa, Florida, United States
CIL #144
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Tampa, Florida, United States
CIL #206
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Omaha, Nebraska, United States
CIL #159
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San Antonio, Texas, United States
CIL #160
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Austin, Texas, United States
CIL #190
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Sacramento, California, United States
CIL #228
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Louisville, Kentucky, United States
CIL #213
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La Mesa, California, United States