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P3 Long Term Safety Study of Once Daily SB204 in Acne

Sponsor
Novan, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02798120
Collaborator
Chiltern International Inc. (Industry)
605
Enrollment
69
Locations
1
Arm
11.5
Actual Duration (Months)
8.8
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
605 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 12, 2016
Actual Primary Completion Date :
Apr 1, 2017
Actual Study Completion Date :
Apr 27, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: SB204 4%

SB204 4% once daily

Drug: SB204 4%
Open label, topical SB204 4%
Other Names:
  • NVN1000

    		•

    Outcome Measures

    Primary Outcome Measures

    1. safety assessments (Reported adverse events) [Week 40/End of Treatment]

      Reported adverse events

    Secondary Outcome Measures

    1. Tolerability assessment (Analysis of tolerability scores at each visit through end of treatment) [Week 40/End of Treatment]

      Analysis of tolerability scores at each visit through end of treatment

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CIL #138 Birmingham Alabama United States 35202
    2 CIL #218 Mobile Alabama United States 36608
    3 CIL #189 Phoenix Arizona United States 85018
    4 CIL #146 Anaheim California United States 92801
    5 CIL #139 Cerritos California United States 90703
    6 CIL #216 Chula Vista California United States 91911
    7 CIL #186 Fresno California United States 93720
    8 CIL #210 Fresno California United States 93720
    9 CIL #174 Huntington Beach California United States 92647
    10 CIL #213 La Mesa California United States 91942
    11 CIL #209 Oceanside California United States 92056
    12 CIL #190 Sacramento California United States 95821
    13 CIL #161 San Diego California United States 92103
    14 CIL #113 San Diego California United States 92123
    15 CIL #195 Santa Ana California United States 92705
    16 CIL #119 Santa Monica California United States 90404
    17 CIL #199 Santa Rosa California United States 95405
    18 CIL #103 Boca Raton Florida United States 33486
    19 CIL #208 Hialeah Florida United States 33012
    20 CIL #212 Homestead Florida United States 33030
    21 CIL #222 Lauderdale Lakes Florida United States 33406
    22 CIL #170 Miami Lakes Florida United States 33016
    23 CIL #204 Miami Springs Florida United States 33166
    24 CIL #172 Orlando Florida United States 32814
    25 CIL #185 Ormond Beach Florida United States 32174
    26 CIL #203 Ormond Beach Florida United States 32174
    27 CIL #110 Pinellas Park Florida United States 33781
    28 CIL #176 Saint Petersburg Florida United States 33716
    29 CIL #227 Sanford Florida United States 32771
    30 CIL #211 South Miami Florida United States 33413
    31 CIL #152 Tampa Florida United States 33607
    32 CIL #229 Tampa Florida United States 33609
    33 CIL #144 Tampa Florida United States 33634
    34 CIL #153 Wellington Florida United States 33414
    35 CIL #116 Newnan Georgia United States 30263
    36 CIL #143 Savannah Georgia United States 31406
    37 CIL #175 New Albany Indiana United States 47150
    38 CIL #191 Overland Park Kansas United States 66215
    39 CIL #215 Wichita Kansas United States 67207
    40 CIL #117 Louisville Kentucky United States 40202
    41 CIL #194 Richmond Kentucky United States 40475
    42 CIL #219 Monroe Louisiana United States 71203
    43 CIL #187 Saint Louis Missouri United States 63141
    44 CIL #148 Norfolk Nebraska United States 68701
    45 CIL #140 Omaha Nebraska United States 68134
    46 CIL #182 Las Vegas Nevada United States 89129
    47 CIL #201 Berlin New Jersey United States 08009
    48 CIL #141 Montclair New Jersey United States 07042
    49 CIL #156 Albuquerque New Mexico United States 87102
    50 CIL #108 Rochester New York United States 14623
    51 CIL #221 Salisbury North Carolina United States 28144
    52 CIL #169 Cincinnati Ohio United States 45246
    53 CIL #226 Cincinnati Ohio United States 45255
    54 CIL #237 Gresham Oregon United States 97030
    55 CIL #200 Portland Oregon United States 97210
    56 CIL #137 Broomall Pennsylvania United States 19008
    57 CIL #178 Philadelphia Pennsylvania United States 19103
    58 CIL #217 Chattanooga Tennessee United States 37421
    59 CIL #198 Arlington Texas United States 76011
    60 CIL #160 Austin Texas United States 78735
    61 CIL #154 Beaumont Texas United States 77701
    62 CIL #184 Bryan Texas United States 77802
    63 CIL #188 Houston Texas United States 77055
    64 CIL #151 Plano Texas United States 75093
    65 CIL #168 Plano Texas United States 75234
    66 CIL #224 San Antonio Texas United States 78218
    67 CIL #106 Salt Lake City Utah United States 84117
    68 CIL #105 Lynchburg Virginia United States 24501
    69 CIL #231 Norfolk Virginia United States 23507

    Sponsors and Collaborators

    • Novan, Inc.
    • Chiltern International Inc.

    Investigators

    • Study Chair: Joyce Rico, Novan, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novan, Inc.
    ClinicalTrials.gov Identifier:
    NCT02798120
    Other Study ID Numbers:
    • NI-AC303
    First Posted:
    Jun 14, 2016
    Last Update Posted:
    Jan 11, 2019
    Last Verified:
    Sep 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 Jan 11, 2019