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

NCT02242760 | Completed Phase 2 Results

• 1 other identifier: NI-AC202
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 20

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.

Conditions

Acne Vulgaris

Keywords

acne

Outcome Measures

Primary Outcomes (3)

• Absolute Change in Inflammatory Lesion Counts

  Change in inflammatory lesion count from Baseline to Week 12

  Baseline and Week 12

• Absolute Change in Non-inflammatory Lesion Counts

  Absolute Change in non-inflammatory lesion count from Baseline to Week 12

  Baseline and 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)

  Baseline and Week 12

Secondary Outcomes (3)

• Percent Change in Inflammatory Lesion Count From Baseline to Week 12

  Baseline and Week 12

• Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12

  Baseline and Week 12

• Median Time to Improvement

  Baseline through Week 12

Study Arms (5)

SB204 2% Twice daily

EXPERIMENTAL

Twice daily SB204 2%

Drug: SB204 2%

SB204 4% daily

EXPERIMENTAL

Once daily SB204 4%

Drug: SB204 4%

Vehicle Gel Daily

PLACEBO COMPARATOR

Vehicle Gel Daily

Drug: Vehicle Gel

Vehicle Gel Twice Daily

PLACEBO COMPARATOR

Twice daily Vehicle Gel

Drug: Vehicle Gel

SB204 4% Twice Daily

EXPERIMENTAL

Twice daily SB204 4%

Drug: SB204 4%

Interventions

SB204 2% DRUG

Applied topically twice daily

Also known as: NVN1000

SB204 2% Twice daily

SB204 4% DRUG

Applied topically daily

Also known as: NVN1000

SB204 4% Twice Daily; SB204 4% daily

Vehicle Gel DRUG

Applied topically twice and once daily

Also known as: Placeco

Vehicle Gel Daily; Vehicle Gel Twice Daily

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Moderate to severe acne
• non-inflammatory lesions at Baseline
• inflammatory lesions at Baseline

You may not qualify if:

• Subjects with known allergy to any component of the test material or vehicle
• Women who are pregnant or nursing

Sponsors & Collaborators

• Novan, Inc.: lead

Study Sites (20)

Qst acne site #1

Hot Springs, Arkansas, 71913, United States

Location

QST Site #118

Encinitas, California, 92024, United States

Location

QST Site #111

San Diego, California, 92123, United States

Location

QST Site #113

San Diego, California, 92123, United States

Location

QST Site #119

Santa Monica, California, 90404, United States

Location

QST Site #103

Boca Raton, Florida, 33486, United States

Location

QST Site # 110

Pinellas Park, Florida, 33781, United States

Location

QST Site # 116

Newnan, Georgia, 302636, United States

Location

QST Site #117

Louisville, Kentucky, 40202, United States

Location

QST Site #112

Detroit, Michigan, 48202, United States

Location

QST Site #120

Warren, Michigan, 48088, United States

Location

QST Site # 121

Minneapolis, Minnesota, 55432, United States

Location

QST Site #107

New York, New York, 10155, United States

Location

QST Site #108

Rochester, New York, 14623, United States

Location

QST Site #109

Rochester, New York, 14625, United States

Location

QST Site #104

Stony Brook, New York, 11790, United States

Location

QST Site # 102

San Antonio, Texas, 78229, United States

Location

QST Site #106

Salt Lake City, Utah, 84117, United States

Location

QST #105

Lynchburg, Virginia, 24501, United States

Location

QST Site #114

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

• M J Rico, MD

  Novan, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 17, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 31, 2023
• Results First Posted: May 31, 2023

Record last verified: 2023-05

Locations

US (20)