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

A Phase 2, Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled Study Comparing the Efficacy, Tolerability, and Safety of SB204 Gel and Vehicle Gel Once or Twice Daily in the Treatment of Acne Vulgaris

Sponsors

Lead Sponsor: Novan, Inc.

Source Novan, Inc.
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.

Detailed Description

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.

Overall Status Completed
Start Date November 2014
Completion Date August 2015
Primary Completion Date June 2015
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Absolute change in inflammatory lesion counts 12 weeks
Absolute change in non-inflammatory lesion counts 12 weeks
Proportion of success according to the dichotomized Investigator Global Assessment [IGA] at end of treatment 12 weeks
Secondary Outcome
Measure Time Frame
Percent change in inflammatory lesion count from Baseline to Week 12 12 weeks
Percent change in non-inflammatory lesion count from Baseline to Week 12 12 weeks
Median time to improvement Baseline through Week 12
Enrollment 213
Condition
Intervention

Intervention Type: Drug

Intervention Name: SB204 2%

Description: Applied topically twice daily

Arm Group Label: SB204 2% Twice daily

Other Name: NVN1000

Intervention Type: Drug

Intervention Name: SB204 4%

Description: Applied topically daily

Other Name: NVN1000

Intervention Type: Drug

Intervention Name: Vehicle Gel

Description: Applied topically twice and once daily

Other Name: Placeco

Eligibility

Criteria:

Inclusion Criteria:

- Moderate to severe acne

- 25-70 non-inflammatory lesions at Baseline

- 20-40 inflammatory lesions at Baseline

Exclusion Criteria:

- Subjects with known allergy to any component of the test material or vehicle

- Women who are pregnant or nursing

Gender: All

Minimum Age: 12 Years

Maximum Age: 40 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
M J Rico, MD Study Director Novan, Inc.
Location
Facility:
Qst acne site #1 | Hot Springs, Arkansas, 71913, United States
QST Site #118 | Encinitas, California, 92024, United States
QST Site #111 | San Diego, California, 92123, United States
QST Site #113 | San Diego, California, 92123, United States
QST Site #119 | Santa Monica, California, 90404, United States
QST Site #103 | Boca Raton, Florida, 33486, United States
QST Site # 110 | Pinellas Park, Florida, 33781, United States
QST Site # 116 | Newnan, Georgia, 302636, United States
QST Site #117 | Louisville, Kentucky, 40202, United States
QST Site #112 | Detroit, Michigan, 48202, United States
QST Site #120 | Warren, Michigan, 48088, United States
QST Site # 121 | Minneapolis, Minnesota, 55432, United States
QST Site #107 | New York, New York, 10155, United States
QST Site #108 | Rochester, New York, 14623, United States
QST Site #109 | Rochester, New York, 14625, United States
QST Site #104 | Stony Brook, New York, 11790, United States
QST Site # 102 | San Antonio, Texas, 78229, United States
QST Site #106 | Salt Lake City, Utah, 84117, United States
QST #105 | Lynchburg, Virginia, 24501, United States
QST Site #114 | Norfolk, Virginia, 23507, United States
Location Countries

United States

Verification Date

November 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: SB204 2% Twice daily

Type: Experimental

Description: Twice daily SB204 2%

Label: SB204 4% daily

Type: Experimental

Description: Once daily SB204 4%

Label: Vehicle Gel Daily

Type: Placebo Comparator

Description: Vehicle Gel Daily

Label: Vehicle Gel Twice Daily

Type: Placebo Comparator

Description: Twice daily Vehicle Gel

Label: SB204 4% Twice Daily

Type: Experimental

Description: Twice daily SB204 4%

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov