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P3 Study in Acne Comparing Once Daily SB204 and Vehicle

Sponsor
Novan, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02672332
Collaborator
Chiltern International Inc. (Industry)
1,306
Enrollment
55
Locations
2
Arms
10
Actual Duration (Months)
23.7
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: SB204 4%
  • Drug: Vehicle Gel
 Phase 3

Detailed 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).

Study Design

Study Type:
Interventional
Actual Enrollment :
1306 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of SB204 and Vehicle Gel Once Daily in the Treatment of Acne Vulgaris
Actual Study Start Date :
Feb 22, 2016
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 21, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: SB204 4%

SB204 4% topically once daily

Drug: SB204 4%
Once daily
Other Names:
  • NVN1000

    		•
    Placebo Comparator: Vehicle Gel

    Vehicle Gel topically once daily

    Drug: Vehicle Gel
    Placebo comparator
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Absolute change in inflammatory lesion counts [From baseline to week 12]

      change in inflammatory lesion counts

    2. Absolute change in non-inflammatory lesion counts [From baseline to week 12]

      change in non-inflammatory lesion counts

    3. Proportion of subjects with Investigator Global Assessment (IGA) Success defined as Clear/Almost Clear and at least 2 grade improvement from Baseline [Week 12]

      IGA success at Week 12

    Secondary Outcome Measures

    1. Per cent change in inflammatory lesion count [Week 12]

      The per change from baseline in inflammatory lesion count

    2. Per cent change in non-inflammatory lesion count [Week 12]

      The per change from baseline in non-inflammatory lesion count

    3. Time to reduction in inflammatory lesion count [Week 12]

      Time to reduction in inflammatory lesion count

    4. Time to improvement in IGA [Week 12]

      Time to improvement in IGA

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    9 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CIL #146 Anaheim California United States 92801
    2 CIL #118 Encinitas California United States 92024
    3 CIL #186 Fresno California United States 93720
    4 CIL #210 Fresno California United States 93720
    5 CIL #209 Oceanside California United States 92056
    6 CIL #161 San Diego California United States 92103
    7 CIL #113 San Diego California United States 92123
    8 CIL #199 Santa Rosa California United States 95405
    9 CIL #103 Boca Raton Florida United States 33486
    10 CIL #173 Hialeah Florida United States 33012
    11 CIL #212 Homestead Florida United States 33030
    12 CIL #222 Lauderdale Lakes Florida United States 33406
    13 CIL #157 Miami Florida United States 33144
    14 CIL #177 North Miami Beach Florida United States 33162
    15 CIL #150 Orlando Florida United States 32801
    16 CIL #172 Orlando Florida United States 32814
    17 CIL #203 Ormond Beach Florida United States 32174
    18 CIL #211 South Miami Florida United States 33413
    19 CIL #229 Tampa Florida United States 33609
    20 CIL #153 Wellington Florida United States 33414
    21 Cil # 179 Chicago Illinois United States 60611
    22 CIL #215 Wichita Kansas United States 67207
    23 CIL #117 Louisville Kentucky United States 40202
    24 CIL #180 New Orleans Louisiana United States 70112
    25 CIL #205 Glenn Dale Maryland United States 20769
    26 CIL #230 Quincy Massachusetts United States 02169
    27 CIL #112 Detroit Michigan United States 48183
    28 CIL #149 Troy Michigan United States 48084
    29 CIL #225 Saint Joseph Missouri United States 64506
    30 CIL #187 Saint Louis Missouri United States 63141
    31 CIL #140 Omaha Nebraska United States 68134
    32 CIL #182 Las Vegas Nevada United States 89129
    33 CIL #201 Berlin New Jersey United States 08009
    34 CIL #141 Montclair New Jersey United States 07042
    35 CIL #156 Albuquerque New Mexico United States 87102
    36 CIL #107 New York New York United States 10155
    37 CIL #108 Rochester New York United States 14623
    38 CIL #104 Stony Brook New York United States 11790
    39 CIL #193 High Point North Carolina United States 27262
    40 CIL #166 Winston-Salem North Carolina United States 27103
    41 CIL #226 Cincinnati Ohio United States 45255
    42 CIL #200 Portland Oregon United States 97210
    43 CIL #236 Charleston South Carolina United States 29414
    44 CIL #217 Chattanooga Tennessee United States 37421
    45 CIL #198 Arlington Texas United States 76011
    46 CIL #154 Beaumont Texas United States 77701
    47 CIL #162 Carrollton Texas United States 75010
    48 CIL #188 Houston Texas United States 77055
    49 CIL #151 Plano Texas United States 75093
    50 CIL #168 Plano Texas United States 75234
    51 CIL #224 San Antonio Texas United States 78218
    52 CIL #171 San Antonio Texas United States 78229
    53 CIL #164 Sugar Land Texas United States 77479
    54 CIL #106 Salt Lake City Utah United States 84117
    55 CIL #114 Norfolk Virginia United States 23502

    Sponsors and Collaborators

    • Novan, Inc.
    • Chiltern International Inc.

    Investigators

    • Study Chair: Joyce Rico, MD, Novan, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novan, Inc.
    ClinicalTrials.gov Identifier:
    NCT02672332
    Other Study ID Numbers:
    • NI-AC301
    First Posted:
    Feb 3, 2016
    Last Update Posted:
    Nov 19, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Acne Vulgaris

    Study Results

    No Results Posted as of Nov 19, 2018