P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne

NCT02667444 | Completed Phase 3 Results

• 1 other identifier: NI-AC302
• Study Type: interventional
• Target: 1,330
• 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

  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 Count

  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

Applied topically once daily

Also known as: NVN1000

SB204 4%

Vehicle Gel DRUG

Applied topically one daily

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 #214

Birmingham, Alabama, 35233, United States

Location

CIL #218

Mobile, Alabama, 36608, United States

Location

CIL #189

Phoenix, Arizona, 85018, United States

Location

CIL #139

Cerritos, California, 90703, United States

Location

CIL #216

Chula Vista, California, 91911, United States

Location

CIL #181

Encino, California, 91436, United States

Location

CIL #174

Huntington Beach, California, 92647, United States

Location

CIL #213

La Mesa, California, 91942, United States

Location

CIL #190

Sacramento, California, 95821, United States

Location

CIL #111

San Diego, California, 92123, United States

Location

CIL #195

Santa Ana, California, 92705, United States

Location

CIL #119

Santa Monica, California, 90404, United States

Location

CIL #158

Bradenton, Florida, 34201, United States

Location

CIL #208

Hialeah, Florida, 33012, United States

Location

CIL #142

Miami, Florida, 33157, United States

Location

CIL #170

Miami Lakes, Florida, 33016, United States

Location

CIL #204

Miami Springs, Florida, 33166, United States

Location

CIL #185

Ormond Beach, Florida, 32174, United States

Location

CIL #110

Pinellas Park, Florida, 33781, United States

Location

CIL #227

Sanford, Florida, 32771, United States

Location

CIL #176

St. Petersburg, Florida, 33716, United States

Location

CIL #152

Tampa, Florida, 33607, United States

Location

CIL #144

Tampa, Florida, 33634, United States

Location

CIL #116

Newnan, Georgia, 30263, United States

Location

CIL #143

Savannah, Georgia, 31406, United States

Location

CIL #175

New Albany, Indiana, 47150, United States

Location

CIL #191

Overland Park, Kansas, 66215, United States

Location

CIL #228

Louisville, Kentucky, 40217, United States

Location

CIL #194

Richmond, Kentucky, 40475, United States

Location

CIL #219

Monroe, Louisiana, 71203, United States

Location

CIL #145

Boston, Massachusetts, 02114, United States

Location

CIL #155

Bay City, Michigan, 48706, United States

Location

CIL #220

St Louis, Missouri, 63141, United States

Location

CIL #148

Norfolk, Nebraska, 68701, United States

Location

CIL #206

Omaha, Nebraska, 68144, United States

Location

CIL #202

Morristown, New Jersey, 07962, United States

Location

CIL #197

New York, New York, 10024, United States

Location

CIL #196

Charlotte, North Carolina, 28277, United States

Location

CIL #192

Raleigh, North Carolina, 27612, United States

Location

CIL #221

Salisbury, North Carolina, 28144, United States

Location

CIL #169

Cincinnati, Ohio, 45246, United States

Location

CIL #237

Gresham, Oregon, 97030, United States

Location

CIL #137

Broomall, Pennsylvania, 19008, United States

Location

CIL #147

Hershey, Pennsylvania, 17033, United States

Location

CIL #178

Philadelphia, Pennsylvania, 19103, United States

Location

CIL #160

Austin, Texas, 78735, United States

Location

CIL #183

Austin, Texas, 78759, United States

Location

CIL #184

Bryan, Texas, 77802, United States

Location

CIL #163

Channelview, Texas, 77530, United States

Location

CIL #165

Dallas, Texas, 75230, United States

Location

CIL #167

Houston, Texas, 77030, United States

Location

CIL #223

Plano, Texas, 75024, United States

Location

CIL #159

San Antonio, Texas, 78229, United States

Location

CIL #105

Lynchburg, Virginia, 24501, United States

Location

CIL #231

Norfolk, Virginia, 23507, 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: January 26, 2016
• First Posted: January 29, 2016
• Study Start: February 19, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 9, 2016
• Last Updated: July 24, 2023
• Results First Posted: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (55)