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Trial record 9 of 11 for:    nvn1000 acne

P3 Study in Acne Comparing Once Daily SB204 and Vehicle

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ClinicalTrials.gov Identifier: NCT02672332
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : December 18, 2017
Sponsor:
Collaborator:
Chiltern International Inc.
Information provided by (Responsible Party):
Novan, Inc.

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: SB204 4% Drug: Placebo (vehicle) Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 1306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of SB204 and Vehicle Gel Once Daily in the Treatment of Acne Vulgaris
Actual Study Start Date : February 22, 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 21, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: SB204 4%
SB204 4% topically once daily
Drug: SB204 4%
Once daily
Other Name: NVN1000

Placebo Comparator: Vehicle Gel
Vehicle Gel topically once daily
Drug: Placebo (vehicle)
Placebo comparator




Primary Outcome Measures :
  1. Absolute change in inflammatory lesion counts [ Time Frame: From baseline to week 12 ]
    change in inflammatory lesion counts

  2. Absolute change in non-inflammatory lesion counts [ Time Frame: From baseline to week 12 ]
    change in non-inflammatory lesion counts

  3. 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


Secondary Outcome Measures :
  1. Per cent change in inflammatory lesion count [ Time Frame: Week 12 ]
    The per change from baseline in inflammatory lesion count

  2. Per cent change in non-inflammatory lesion count [ Time Frame: Week 12 ]
    The per change from baseline in non-inflammatory lesion count

  3. Time to reduction in inflammatory lesion count [ Time Frame: Week 12 ]
    Time to reduction in inflammatory lesion count

  4. Time to improvement in IGA [ Time Frame: Week 12 ]
    Time to improvement in IGA



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Ages Eligible for Study:   9 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672332


  Show 55 Study Locations
Sponsors and Collaborators
Novan, Inc.
Chiltern International Inc.
Investigators
Study Chair: Joyce Rico, MD Novan, Inc.

Additional Information:
Responsible Party: Novan, Inc.
ClinicalTrials.gov Identifier: NCT02672332     History of Changes
Other Study ID Numbers: NI-AC301
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases