Trial record 7 of 13 for:    nvn1000 acne

P3 Long Term Safety Study of Once Daily SB204 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. Identifier: NCT02798120
Recruitment Status : Completed
First Posted : June 14, 2016
Last Update Posted : September 7, 2018
Chiltern International Inc.
Information provided by (Responsible Party):
Novan, Inc.

Brief Summary:
This is a multi-center, open label long-term safety (LTS) study to be conducted in approximately 600 subjects with acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: SB204 4% Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 605 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris
Actual Study Start Date : May 12, 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: SB204 4%
SB204 4% once daily
Drug: SB204 4%
Open label, topical SB204 4%
Other Name: NVN1000

Primary Outcome Measures :
  1. safety assessments (Reported adverse events) [ Time Frame: Week 40/End of Treatment ]
    Reported adverse events

Secondary Outcome Measures :
  1. Tolerability assessment (Analysis of tolerability scores at each visit through end of treatment) [ Time Frame: Week 40/End of Treatment ]
    Analysis of tolerability scores at each visit through end of treatment

Information from the National Library of Medicine

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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

Inclusion Criteria:

  • Have completed 12 weeks of treatment in NI-AC301 or NI-AC302

Exclusion Criteria:

  • Terminated early from an SB204 Phase 3 pivotal study for any reason
  • Have an on-going adverse event at Week 12 visit for NI-AC301 or NI-AC302 that warrants stopping study drug application
  • Have used medications or vitamins during the 12 weeks immediately preceding this study which were reported to exacerbate 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 identifier (NCT number): NCT02798120

  Show 69 Study Locations
Sponsors and Collaborators
Novan, Inc.
Chiltern International Inc.
Study Chair: Joyce Rico Novan, Inc.

Responsible Party: Novan, Inc. Identifier: NCT02798120     History of Changes
Other Study ID Numbers: NI-AC303
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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