P3 Study in Acne Comparing Once Daily SB204 and Vehicle

Acne Vulgaris Clinical Trial

Official title:

A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of SB204 and Vehicle Gel Once Daily in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02672332
• Other study ID #: NI-AC301
• Status: Completed
• Phase: Phase 3
• Start date: February 22, 2016
• Est. completion date: December 21, 2016

Study information

• Verified date: April 2023
• Source: Novan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1307
• Est. completion date: December 21, 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• SB204 4%
Once daily
• Vehicle Gel
Placebo comparator

Locations

Country	Name	City	State
United States	CIL #156	Albuquerque	New Mexico
United States	CIL #146	Anaheim	California
United States	CIL #198	Arlington	Texas
United States	CIL #154	Beaumont	Texas
United States	CIL #201	Berlin	New Jersey
United States	CIL #103	Boca Raton	Florida
United States	CIL #162	Carrollton	Texas
United States	CIL #236	Charleston	South Carolina
United States	CIL #217	Chattanooga	Tennessee
United States	Cil # 179	Chicago	Illinois
United States	CIL #226	Cincinnati	Ohio
United States	CIL #112	Detroit	Michigan
United States	CIL #118	Encinitas	California
United States	CIL #186	Fresno	California
United States	CIL #210	Fresno	California
United States	CIL #205	Glenn Dale	Maryland
United States	CIL #173	Hialeah	Florida
United States	CIL #193	High Point	North Carolina
United States	CIL #212	Homestead	Florida
United States	CIL #188	Houston	Texas
United States	CIL #182	Las Vegas	Nevada
United States	CIL #222	Lauderdale Lakes	Florida
United States	CIL #117	Louisville	Kentucky
United States	CIL #157	Miami	Florida
United States	CIL #141	Montclair	New Jersey
United States	CIL #180	New Orleans	Louisiana
United States	CIL #107	New York	New York
United States	CIL #114	Norfolk	Virginia
United States	CIL #177	North Miami Beach	Florida
United States	CIL #209	Oceanside	California
United States	CIL #140	Omaha	Nebraska
United States	CIL #150	Orlando	Florida
United States	CIL #172	Orlando	Florida
United States	CIL #203	Ormond Beach	Florida
United States	CIL #151	Plano	Texas
United States	CIL #168	Plano	Texas
United States	CIL #200	Portland	Oregon
United States	CIL #230	Quincy	Massachusetts
United States	CIL #108	Rochester	New York
United States	CIL #225	Saint Joseph	Missouri
United States	CIL #187	Saint Louis	Missouri
United States	CIL #106	Salt Lake City	Utah
United States	CIL #171	San Antonio	Texas
United States	CIL #224	San Antonio	Texas
United States	CIL #113	San Diego	California
United States	CIL #161	San Diego	California
United States	CIL #199	Santa Rosa	California
United States	CIL #211	South Miami	Florida
United States	CIL #104	Stony Brook	New York
United States	CIL #164	Sugar Land	Texas
United States	CIL #229	Tampa	Florida
United States	CIL #149	Troy	Michigan
United States	CIL #153	Wellington	Florida
United States	CIL #215	Wichita	Kansas
United States	CIL #166	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Novan, Inc.	Chiltern International Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.; Almost clear: Rare non-inflammatory lesions with rare papules (papules may be resolving and hyperpigmented, though not pink-red).; Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions.; Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one nodulocystic lesion.; Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodulocystic lesions	Baseline and Week 12
Secondary	Percent Change in Inflammatory Lesion Count	The percent change from baseline in inflammatory lesion count	Baseline and Week 12
Secondary	Percent Change in Non-inflammatory Lesion Count	The percent change from baseline in non-inflammatory lesion count	Baseline and Week 12
Secondary	Time to Reduction in Inflammatory Lesion Counts	Median time to a 35% reduction in inflammatory lesion count (Kaplan-Meier)	Week 12
Secondary	Time to Improvement in IGA	Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis).	Week 12

External Links

•   Study specific web site