P3 Study in Acne Comparing Once Daily SB204 and Vehicle

NCT02672332 | Completed Phase 3 Results

• 1 other identifier: NI-AC301
• Study Type: interventional
• Target: 1,307
• Locations: 1 country
• Sites: 55

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and Week 12

• 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).

  Baseline and Week 12

• 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. 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

  Baseline and Week 12

Secondary Outcomes (4)

• Percent Change in Inflammatory Lesion Count

  Baseline and Week 12

• Percent Change in Non-inflammatory Lesion Count

  Baseline and Week 12

• Time to Reduction in Inflammatory Lesion Counts

  Week 12

• Time to Improvement in IGA

  Week 12

Study Arms (2)

SB204 4%

EXPERIMENTAL

SB204 4% topically once daily

Drug: SB204 4%

Vehicle Gel

PLACEBO COMPARATOR

Vehicle Gel topically once daily

Drug: Vehicle Gel

Interventions

SB204 4% DRUG

Once daily

Also known as: NVN1000

SB204 4%

Vehicle Gel DRUG

Placebo comparator

Also known as: Placebo

Vehicle Gel

Eligibility Criteria

• Age: 9 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novan, Inc.: lead
• Chiltern International Inc.: collaborator

Study Sites (55)

CIL #146

Anaheim, California, 92801, United States

Location

CIL #118

Encinitas, California, 92024, United States

Location

CIL #186

Fresno, California, 93720, United States

Location

CIL #210

Fresno, California, 93720, United States

Location

CIL #209

Oceanside, California, 92056, United States

Location

CIL #161

San Diego, California, 92103, United States

Location

CIL #113

San Diego, California, 92123, United States

Location

CIL #199

Santa Rosa, California, 95405, United States

Location

CIL #103

Boca Raton, Florida, 33486, United States

Location

CIL #173

Hialeah, Florida, 33012, United States

Location

CIL #212

Homestead, Florida, 33030, United States

Location

CIL #222

Lauderdale Lakes, Florida, 33406, United States

Location

CIL #157

Miami, Florida, 33144, United States

Location

CIL #177

North Miami Beach, Florida, 33162, United States

Location

CIL #150

Orlando, Florida, 32801, United States

Location

CIL #172

Orlando, Florida, 32814, United States

Location

CIL #203

Ormond Beach, Florida, 32174, United States

Location

CIL #211

South Miami, Florida, 33413, United States

Location

CIL #229

Tampa, Florida, 33609, United States

Location

CIL #153

Wellington, Florida, 33414, United States

Location

Cil # 179

Chicago, Illinois, 60611, United States

Location

CIL #215

Wichita, Kansas, 67207, United States

Location

CIL #117

Louisville, Kentucky, 40202, United States

Location

CIL #180

New Orleans, Louisiana, 70112, United States

Location

CIL #205

Glenn Dale, Maryland, 20769, United States

Location

CIL #230

Quincy, Massachusetts, 02169, United States

Location

CIL #112

Detroit, Michigan, 48183, United States

Location

CIL #149

Troy, Michigan, 48084, United States

Location

CIL #225

Saint Joseph, Missouri, 64506, United States

Location

CIL #187

St Louis, Missouri, 63141, United States

Location

CIL #140

Omaha, Nebraska, 68134, United States

Location

CIL #182

Las Vegas, Nevada, 89129, United States

Location

CIL #201

Berlin, New Jersey, 08009, United States

Location

CIL #141

Montclair, New Jersey, 07042, United States

Location

CIL #156

Albuquerque, New Mexico, 87102, United States

Location

CIL #107

New York, New York, 10155, United States

Location

CIL #108

Rochester, New York, 14623, United States

Location

CIL #104

Stony Brook, New York, 11790, United States

Location

CIL #193

High Point, North Carolina, 27262, United States

Location

CIL #166

Winston-Salem, North Carolina, 27103, United States

Location

CIL #226

Cincinnati, Ohio, 45255, United States

Location

CIL #200

Portland, Oregon, 97210, United States

Location

CIL #236

Charleston, South Carolina, 29414, United States

Location

CIL #217

Chattanooga, Tennessee, 37421, United States

Location

CIL #198

Arlington, Texas, 76011, United States

Location

CIL #154

Beaumont, Texas, 77701, United States

Location

CIL #162

Carrollton, Texas, 75010, United States

Location

CIL #188

Houston, Texas, 77055, United States

Location

CIL #151

Plano, Texas, 75093, United States

Location

CIL #168

Plano, Texas, 75234, United States

Location

CIL #224

San Antonio, Texas, 78218, United States

Location

CIL #171

San Antonio, Texas, 78229, United States

Location

CIL #164

Sugar Land, Texas, 77479, United States

Location

CIL #106

Salt Lake City, Utah, 84117, United States

Location

CIL #114

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

berdazimer sodium

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Cathy White, Vice President, Drug Development Operations
• Organization: Novan, Inc.

clinical@novan.com

919-485-8080

Study Officials

• Joyce Rico, MD

  Novan, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 3, 2016
• Study Start: February 22, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 21, 2016
• Last Updated: July 24, 2023
• Results First Posted: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (55)