P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne

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 Once Daily SB204 and Vehicle Gel in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667444
• Other study ID #: NI-AC302
• Status: Completed
• Phase: Phase 3
• Start date: February 19, 2016
• Est. completion date: December 9, 2016

Study information

• Verified date: July 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: 1330
• Est. completion date: December 9, 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%
Applied topically once daily
• Vehicle Gel
Applied topically one daily

Locations

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

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	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 Count	Median time to a 35% reduction (improvement) in inflammatory lesion count (Kaplan-Meier analysis)	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