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Trial record 14 of 166 for:    acne AND Vehicle

P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02667444
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
Chiltern International Inc.
Information provided by (Responsible Party):
Novan, Inc.

Tracking Information
First Submitted Date  ICMJE January 26, 2016
First Posted Date  ICMJE January 29, 2016
Last Update Posted Date May 15, 2019
Actual Study Start Date  ICMJE February 19, 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2016)
  • Absolute change in inflammatory lesion counts [ Time Frame: From baseline to week 12 ]
    change in inflammatory lesion counts
  • Absolute change in non-inflammatory lesion counts [ Time Frame: From baseline to week 12 ]
    change in non-inflammatory lesion counts
  • Proportion of subjects with Investigator Global Assessment (IGA) Success defined as Clear/Almost Clear and at least 2 grade improvement from Baseline [ Time Frame: Week 12 ]
    IGA success at Week 12
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
  • Absolute change in inflammatory lesion counts [ Time Frame: From baseline to week 12 ]
    change in inflammatory lesion counts
  • Absolute change in non-inflammatory lesion counts [ Time Frame: From baseline to week 12 ]
    change in non-inflammatory lesion counts
  • Proportion of subjects with Investigator Global Assessment (IGA) Success [ Time Frame: Week 12 ]
    IGA success at Week 12
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
  • Per cent change in inflammatory lesion count [ Time Frame: Week 12 ]
    The per change from baseline in inflammatory lesion count
  • Per cent change in non-inflammatory lesion count [ Time Frame: Week 12 ]
    The per change from baseline in non-inflammatory lesion count
  • Time to reduction in inflammatory lesion count [ Time Frame: Week 12 ]
    Time to reduction in inflammatory lesion count
  • Time to improvement in IGA [ Time Frame: Week 12 ]
    Time to improvement in IGA
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne
Official Title  ICMJE A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of Once Daily SB204 and Vehicle Gel in the Treatment of Acne Vulgaris
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: SB204 4%
    Applied topically once daily
    Other Name: NVN1000
  • Drug: Vehicle Gel
    Applied topically one daily
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: SB204 4%
    SB204 4% topically once daily
    Intervention: Drug: SB204 4%
  • Placebo Comparator: Vehicle Gel
    Vehicle Gel topically once daily
    Intervention: Drug: Vehicle Gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2018)
1330
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2016)
1300
Actual Study Completion Date  ICMJE December 9, 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02667444
Other Study ID Numbers  ICMJE NI-AC302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Novan, Inc.
Study Sponsor  ICMJE Novan, Inc.
Collaborators  ICMJE Chiltern International Inc.
Investigators  ICMJE
Study Chair: Joyce Rico, MD Novan, Inc.
PRS Account Novan, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP