P3 Long Term Safety Study of Once Daily SB204 in Acne

Acne Vulgaris Clinical Trial

Official title:

A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02798120
• Other study ID #: NI-AC303
• Status: Completed
• Phase: Phase 3
• Start date: May 12, 2016
• Est. completion date: April 27, 2017

Study information

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

Clinical Trial Summary

This is a multi-center, open label long-term safety (LTS) study to be conducted in approximately 600 subjects with acne vulgaris.

Description:

A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: April 27, 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 99 Years

Eligibility

Inclusion Criteria:

• Have completed 12 weeks of treatment in NI-AC301 or NI-AC302

Exclusion Criteria:

• Terminated early from an SB204 Phase 3 pivotal study for any reason

• Have an on-going adverse event at Week 12 visit for NI-AC301 or NI-AC302 that warrants stopping study drug application

• Have used medications or vitamins during the 12 weeks immediately preceding this study which were reported to exacerbate acne.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• SB204 4%
Open label, topical SB204 4%

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 #160	Austin	Texas
United States	CIL #154	Beaumont	Texas
United States	CIL #201	Berlin	New Jersey
United States	CIL #138	Birmingham	Alabama
United States	CIL #103	Boca Raton	Florida
United States	CIL #137	Broomall	Pennsylvania
United States	CIL #184	Bryan	Texas
United States	CIL #139	Cerritos	California
United States	CIL #217	Chattanooga	Tennessee
United States	CIL #216	Chula Vista	California
United States	CIL #169	Cincinnati	Ohio
United States	CIL #226	Cincinnati	Ohio
United States	CIL #186	Fresno	California
United States	CIL #210	Fresno	California
United States	CIL #237	Gresham	Oregon
United States	CIL #208	Hialeah	Florida
United States	CIL #212	Homestead	Florida
United States	CIL #188	Houston	Texas
United States	CIL #174	Huntington Beach	California
United States	CIL #213	La Mesa	California
United States	CIL #182	Las Vegas	Nevada
United States	CIL #222	Lauderdale Lakes	Florida
United States	CIL #117	Louisville	Kentucky
United States	CIL #105	Lynchburg	Virginia
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 #141	Montclair	New Jersey
United States	CIL #175	New Albany	Indiana
United States	CIL #116	Newnan	Georgia
United States	CIL #148	Norfolk	Nebraska
United States	CIL #231	Norfolk	Virginia
United States	CIL #209	Oceanside	California
United States	CIL #140	Omaha	Nebraska
United States	CIL #172	Orlando	Florida
United States	CIL #185	Ormond Beach	Florida
United States	CIL #203	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 #151	Plano	Texas
United States	CIL #168	Plano	Texas
United States	CIL #200	Portland	Oregon
United States	CIL #194	Richmond	Kentucky
United States	CIL #108	Rochester	New York
United States	CIL #190	Sacramento	California
United States	CIL #187	Saint Louis	Missouri
United States	CIL #176	Saint Petersburg	Florida
United States	CIL #221	Salisbury	North Carolina
United States	CIL #106	Salt Lake City	Utah
United States	CIL #224	San Antonio	Texas
United States	CIL #113	San Diego	California
United States	CIL #161	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 #199	Santa Rosa	California
United States	CIL #143	Savannah	Georgia
United States	CIL #211	South Miami	Florida
United States	CIL #144	Tampa	Florida
United States	CIL #152	Tampa	Florida
United States	CIL #229	Tampa	Florida
United States	CIL #153	Wellington	Florida
United States	CIL #215	Wichita	Kansas

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	Number of Subjects With Adverse Events Ongoing From Parent Study at Start of Study NI-AC303)	This outcome measure shows the number of subjects with at least one ongoing adverse event from the pivotal studies (NI-AC301 and NI-AC302) at the time they rolled over into this study (NI-AC303). The final study visit (Week 12) for the pivotal studies served as the Baseline visit for this study. Subjects who were assigned to SB204 in the pivotal studies are denoted as SB204 Experienced and subjects who were assigned to Vehicle Gel on the pivotal studies are denoted as SB204 Naive.	Baseline
Primary	Number of Subjects With Treatment Emergent Adverse Events	Number of subjects with adverse events that had an onset date on or after entry into study NI-AC303.	Week 40/End of Treatment
Secondary	Tolerability Assessment (Analysis of Tolerability Scores at Each Visit Through End of Treatment)	Analysis of cutaneous tolerability scores at each visit through end of treatment. Baseline is the Week 12 assessment from the previous study (NI-AC301 or NI-AC302). The Cutaneous Tolerability Assessment scale consisted of the investigator's assessment of erythema, scaling, and dryness at the time the assessment was made. Pruritus and burning/stinging were based on the subject's report for the previous 24 hours. Each component was graded on a scale of 0-3, with 0 being none (not present) and 3 being severe. Higher scores indicated a higher severity of reaction.	Baseline, Week 4, Week 12, Week 24, Week 36, Week 40
Secondary	Inflammatory Lesion Counts by Study Visit	Absolute count of inflammatory lesions at each visit (face only)--safety population	Baseline through Week 40
Secondary	Non-Inflammatory Lesion Counts by Study Visit	Absolute count of non-inflammatory lesions by study visit (face only)	Baseline through Week 40