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Study of NVN1000 Topical Gel and Topical Gel Vehicle in the Treatment of Moderate to Severe Acne Vulgaris

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: NCT01556698
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Novan, Inc.

Tracking Information
First Submitted Date  ICMJE March 14, 2012
First Posted Date  ICMJE March 16, 2012
Last Update Posted Date November 19, 2018
Study Start Date  ICMJE July 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01556698 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of NVN1000 Topical Gel and Topical Gel Vehicle in the Treatment of Moderate to Severe Acne Vulgaris
Official Title  ICMJE Single-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison, Proof of Concept Study Comparing the Tolerability, Safety and Efficacy of NVN1000 Topical Gel Gel Vehicle in the Treatment of Moderate to Severe Acne
Brief Summary The primary objective of this study is to compare the tolerability, safety and efficacy of NVN1000 Topical Gel and Topical Gel Vehicle in the treatment of subjects with moderate to severe acne vulgaris.
Detailed Description The objective of this study is to evaluate the tolerability, safety and efficacy of once daily application of NVN1000 Topical Gel for 8 weeks in comparison with its vehicle in subjects with moderate to severe acne.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Acne Vulgaris
  • Acne
Intervention  ICMJE
  • Drug: NVN1000
    Other Name: Nitric Oxide 0.3%
  • Drug: Vehicle
    Placebo
    Other Name: Vehicle Comparator
Study Arms  ICMJE
  • Experimental: NVN1000 Gel
    NVN1000 Gel topically applied one daily at bedtime for 8 weeks
    Intervention: Drug: NVN1000
  • Placebo Comparator: Vehicle Gel
    Vehicle Gel topically applied once daily at bedtime for 8 weeks
    Intervention: Drug: Vehicle
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)
70
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Baseline IGA score of moderate (3) or severe (4)
  • Minimum of 20 but no more than 40 facial inflammatory lesions
  • Minimum of 20 but not more than 60 facial non-inflammatory lesions
  • No more than 2 facial nodules

Exclusion Criteria:

  • Dermatological conditions on the face that could interfere with clinical evaluations
  • Underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive
  • History of experiencing significant burning or stinging when applying any facial treatment
  • Female subjects, if they are pregnant,nursing mothers, or planning to become pregnant during the study
  • Have used estrogens or oral contraceptives for less than 90 days immediately preceding the Baseline visit, discontinued use of estrogens or oral contraceptives less than 90 days prior to Baseline,or planning to begin or discontinue use of this therapy during the treatment period
  • Have used medications and/or vitamins which are reported to exacerbate acne during the 180 days immediately preceding the Baseline visit
  • Use concomitantly over-the-counter (OTC) products that contain ingredients such as benzoyl peroxide,salicylic acid,alpha-hydroxy acid,retinol or glycolic acids
  • Have not undergone the specified washouts for topical preparations,systemic medications and procedures noted in the protocol
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
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01556698
Other Study ID Numbers  ICMJE NI-AC001
Has Data Monitoring Committee Not Provided
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
Principal Investigator: Daisy Blanco, MD Instituto Dermatológico
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