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

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Vehicle Gel; Drug: SB204 4%; Drug: SB204 2%

• Registration Number: NCT02242760
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-17
• Study Start: 2014-11
• Primary Completion: 2015-06
• Study Completion: 2015-08
• Disposition First Submitted: 2017-12-18
• Disposition First Submitted QC: 2017-12-18
• Disposition First Posted: 2017-12-20
• Results First Submitted: 2023-03-20
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-26
• Last Update Submitted: 2023-05-26
• Results First Posted: 2023-05-31
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle Gel Twice Daily	Vehicle Gel	Twice daily Vehicle Gel
SB204 4% Twice Daily	SB204 4%	Twice daily SB204 4%
SB204 2% Twice daily	SB204 2%	Twice daily SB204 2%
SB204 4% daily	SB204 4%	Once daily SB204 4%
Vehicle Gel Daily	Vehicle Gel	Vehicle Gel Daily

Primary Outcome Measures

Name	Time	Method
Absolute Change in Inflammatory Lesion Counts	Baseline and Week 12	Change in inflammatory lesion count from Baseline to Week 12
Absolute Change in Non-inflammatory Lesion Counts	Baseline and Week 12	Absolute Change in non-inflammatory lesion count from Baseline to Week 12
Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment	Baseline and Week 12	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)

Secondary Outcome Measures

Name	Time	Method
Percent Change in Inflammatory Lesion Count From Baseline to Week 12	Baseline and Week 12	The percent change in inflammatory lesion count from Baseline to Week 12
Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12	Baseline and Week 12	The percent change in non-inflammatory lesion count from Baseline to Week 12
Median Time to Improvement	Baseline through Week 12	Median time to a 35% improvement in inflammatory lesion counts (Kaplan-Meier estimate). The full range values presented below are estimates made from the Kaplan-Meier figure.

Trial Locations

Locations (20)

QST Site #103; 🇺🇸 Boca Raton, Florida, United States

QST Site #111; 🇺🇸 San Diego, California, United States

QST Site # 121; 🇺🇸 Minneapolis, Minnesota, United States

QST Site # 102; 🇺🇸 San Antonio, Texas, United States

Qst acne site #1; 🇺🇸 Hot Springs, Arkansas, United States

QST Site #113; 🇺🇸 San Diego, California, United States

QST Site #119; 🇺🇸 Santa Monica, California, United States

QST Site # 110; 🇺🇸 Pinellas Park, Florida, United States

QST Site # 116; 🇺🇸 Newnan, Georgia, United States

QST Site #120; 🇺🇸 Warren, Michigan, United States

QST Site #108; 🇺🇸 Rochester, New York, United States

QST Site #109; 🇺🇸 Rochester, New York, United States

QST Site #107; 🇺🇸 New York, New York, United States

QST Site #114; 🇺🇸 Norfolk, Virginia, United States

QST #105; 🇺🇸 Lynchburg, Virginia, United States

QST Site #118; 🇺🇸 Encinitas, California, United States

QST Site #104; 🇺🇸 Stony Brook, New York, United States

QST Site #117; 🇺🇸 Louisville, Kentucky, United States

QST Site #112; 🇺🇸 Detroit, Michigan, United States

QST Site #106; 🇺🇸 Salt Lake City, Utah, United States