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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: SB204 2%; Drug: SB204 4%; Drug: Vehicle Gel

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 Type: Interventional
• Enrollment (Actual): 213
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SB204 2% Twice daily; Twice daily SB204 2%	Drug: SB204 2%; Applied topically twice daily; Other Names: NVN1000
Experimental: SB204 4% daily; Once daily SB204 4%	Drug: SB204 4%; Applied topically daily; Other Names: NVN1000
Placebo Comparator: Vehicle Gel Daily	Drug: Vehicle Gel; Applied topically twice and once daily; Other Names: Placeco
Placebo Comparator: Vehicle Gel Twice Daily; Twice daily Vehicle Gel	Drug: Vehicle Gel; Applied topically twice and once daily; Other Names: Placeco
Experimental: SB204 4% Twice Daily; Twice daily SB204 4%	Drug: SB204 4%; Applied topically daily; Other Names: NVN1000

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Inflammatory Lesion Count From Baseline to Week 12	The percent change in inflammatory lesion count from Baseline to Week 12	Baseline and Week 12
Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12	The percent change in non-inflammatory lesion count from Baseline to Week 12	Baseline and Week 12
Median Time to Improvement	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.	Baseline through Week 12

Collaborators and Investigators

• Sponsor: Novan, Inc.
• Investigators: Study Director: M J Rico, MD, Novan, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: September 10, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (Estimated): September 17, 2014

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: acne
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: NI-AC202