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Trial record 7 of 11 for:    nvn1000 acne

P3 Long Term Safety Study of Once Daily SB204 in Acne

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ClinicalTrials.gov Identifier: NCT02798120
Recruitment Status : Completed
First Posted : June 14, 2016
Last Update Posted : December 18, 2017
Sponsor:
Collaborator:
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



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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:

  • 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 ClinicalTrials.gov identifier (NCT number): NCT02798120


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

Responsible Party: Novan, Inc.
ClinicalTrials.gov Identifier: NCT02798120     History of Changes
Other Study ID Numbers: NI-AC303
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: August 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