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A Phase 2, 3 Arm Study of NVN1000 Gel and Vehicle Gel in Subjects With 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: NCT01844752
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Novan, Inc.

Tracking Information
First Submitted Date  ICMJE April 29, 2013
First Posted Date  ICMJE May 1, 2013
Last Update Posted Date November 19, 2018
Study Start Date  ICMJE April 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2013)
The absolute change from baseline in non-inflammatory lesion counts at Week 12 [ Time Frame: 12 weeks ]
The absolute change from baseline in non-inflammatory lesion counts at Week 12
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01844752 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2013)
  • The absolute change from baseline in inflammatory lesion counts at Week 12 [ Time Frame: 12 weeks ]
    The absolute change from baseline in inflammatory lesion counts at Week 12
  • Success on the Investigator Global Assessment (IGA) at Week 12 [ Time Frame: 12 week ]
    Analysis of the dichotomized IGA scores (success vs failure) at Week 12. "Success" is defined as a score of "clear" or "almost clear" and a 2 point improvement in the IGA score from Baseline.
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 A Phase 2, 3 Arm Study of NVN1000 Gel and Vehicle Gel in Subjects With Acne
Official Title  ICMJE A Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled, Parallel Group, 3-arm Study Comparing the Efficacy, Tolerability and Safety of 2 Concentrations of NVN1000 Gel and Vehicle Gel Twice Daily in the Treatment of Acne Vulgaris.
Brief Summary This is a 12 week clinical trial in subjects with acne vulgaris. Subjects will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel twice daily. Safety, tolerability and efficacy will be assessed over the course of the study.
Detailed Description This is a multi-center, evaluator and subject blinded, randomized, vehicle-controlled, parallel group, dose-ranging study to be conducted in approximately 150 subjects with acne vulgaris. Subjects who satisfy the entry criteria at the Baseline visit will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel in a 1:1:1 ratio. Efficacy assessments will include inflammatory and non-inflammatory lesion counts and investigator global assessments (IGA). Tolerability and safety assessments include cutaneous tolerability evaluation, adverse event collection, physical exams, and laboratory studies. Subjects will return for post-baseline evaluation at Weeks 2, 4, 8, and 12.
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: NVN1000 1% Gel
    Twice daily NVN1000 1% Gel for 12 weeks
    Other Name: NVN1000
  • Drug: NVN1000 4% Gel
    Twice daily NVN1000 4% Gel for 12 weeks
    Other Name: NVN1000
  • Drug: Vehicle Gel
    Twice daily Vehicle Gel for 12 weeks
    Other Name: Comparator Gel
Study Arms  ICMJE
  • Experimental: NVN1000 1% Gel
    NVN1000 1% Gel twice daily
    Intervention: Drug: NVN1000 1% Gel
  • Experimental: NVN1000 4% Gel
    NVN1000 4% Gel twice daily
    Intervention: Drug: NVN1000 4% Gel
  • Placebo Comparator: Vehicle Gel
    Vehicle Gel twice daily
    Intervention: Drug: Vehicle Gel
Publications * Baldwin H, Blanco D, McKeever C, Paz N, Vasquez YN, Quiring J, Enloe C, De León E, Stasko N. Results of a Phase 2 Efficacy and Safety Study with SB204, an Investigational Topical Nitric Oxide-releasing Drug for the Treatment of Acne Vulgaris. J Clin Aesthet Dermatol. 2016 Aug;9(8):12-8. Epub 2016 Aug 1.

*   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 10, 2014)
153
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2013)
150
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with acne vulgaris and at least 20 but no more than 40 inflammatory lesions, 25-70 non-inflammatory lesions, no more than 2 nodules on the face
  • Baseline IGA score of mild, moderate or severe
  • Women of child-bearing potential must agree to use an effective method of birth control during the study and for 30 days after their final study visit

Exclusion Criteria:

  • Any dermatologic condition or other medical problem that could interfere with clinical evaluation or requires the use of topical or systemic therapy that make evaluations and lesion count inconclusive
  • Female subjects who are pregnant, nursing, or considering becoming pregnant
  • Methemoglobin > 2% at baseline
  • Clinically significant anemia at baseline
  • Use of topical or systemic medications to treat acne
  • Use of medications that make acne worse, associated with methemoglobinemia, or nitric oxide donors
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 Dominican Republic,   Honduras,   Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01844752
Other Study ID Numbers  ICMJE NI-AC201
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: Joyce 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