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Trial record 72 of 233 for:    acne AND Percent

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

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ClinicalTrials.gov Identifier: NCT02242760
Recruitment Status : Completed
First Posted : September 17, 2014
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Novan, Inc.

Tracking Information
First Submitted Date  ICMJE September 10, 2014
First Posted Date  ICMJE September 17, 2014
Last Update Posted Date January 11, 2019
Study Start Date  ICMJE November 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2019)
  • Absolute change in inflammatory lesion counts [ Time Frame: 12 weeks ]
    Change in inflammatory lesion count from Baseline to Week 12
  • Absolute change in non-inflammatory lesion counts [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2014)
  • Absolute change in inflammatory lesion counts [ Time Frame: 12 weeks ]
  • Absolute change in non-inflammatory lesion counts [ Time Frame: 12 weeks ]
  • Proportion of success according to the dichotomized Investigator Global Assessment [IGA] at end of treatment [ Time Frame: 12 weeks ]
    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
Change History Complete list of historical versions of study NCT02242760 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2019)
  • Percent change in inflammatory lesion count from Baseline to Week 12 [ Time Frame: 12 weeks ]
    The percent change in inflammatory lesion count from Baseline to Week 12
  • Percent change in non-inflammatory lesion count from Baseline to Week 12 [ Time Frame: 12 weeks ]
    The percent change in non-inflammatory lesion count from Baseline to Week 12
  • Median time to improvement [ Time Frame: Baseline through Week 12 ]
    Decrease in lesion count from Baseline to Week 12
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2014)
  • Percent change in inflammatory lesion count from Baseline to Week 12 [ Time Frame: 12 weeks ]
  • Percent change in non-inflammatory lesion count from Baseline to Week 12 [ Time Frame: 12 weeks ]
  • Median time to improvement [ Time Frame: Baseline through Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: SB204 2%
    Applied topically twice daily
    Other Name: NVN1000
  • Drug: SB204 4%
    Applied topically daily
    Other Name: NVN1000
  • Drug: Vehicle Gel
    Applied topically twice and once daily
    Other Name: Placeco
Study Arms  ICMJE
  • Experimental: SB204 2% Twice daily
    Twice daily SB204 2%
    Intervention: Drug: SB204 2%
  • Experimental: SB204 4% daily
    Once daily SB204 4%
    Intervention: Drug: SB204 4%
  • Placebo Comparator: Vehicle Gel Daily
    Vehicle Gel Daily
    Intervention: Drug: Vehicle Gel
  • Placebo Comparator: Vehicle Gel Twice Daily
    Twice daily Vehicle Gel
    Intervention: Drug: Vehicle Gel
  • Experimental: SB204 4% Twice Daily
    Twice daily SB204 4%
    Intervention: Drug: SB204 4%
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: January 3, 2017)
213
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2014)
200
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 40 Years   (Child, 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 NCT02242760
Other Study ID Numbers  ICMJE NI-AC202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novan, Inc.
Study Sponsor  ICMJE Novan, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: M J Rico, MD Novan, Inc.
PRS Account Novan, Inc.
Verification Date November 2018

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