P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne

July 12, 2023 updated by: Novan, Inc.

A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of Once Daily SB204 and Vehicle Gel in the Treatment of Acne Vulgaris

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • CIL #214
      • Mobile, Alabama, United States, 36608
        • CIL #218
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • CIL #189
    • California
      • Cerritos, California, United States, 90703
        • CIL #139
      • Chula Vista, California, United States, 91911
        • CIL #216
      • Encino, California, United States, 91436
        • CIL #181
      • Huntington Beach, California, United States, 92647
        • CIL #174
      • La Mesa, California, United States, 91942
        • CIL #213
      • Sacramento, California, United States, 95821
        • CIL #190
      • San Diego, California, United States, 92123
        • CIL #111
      • Santa Ana, California, United States, 92705
        • CIL #195
      • Santa Monica, California, United States, 90404
        • CIL #119
    • Florida
      • Bradenton, Florida, United States, 34201
        • CIL #158
      • Hialeah, Florida, United States, 33012
        • CIL #208
      • Miami, Florida, United States, 33157
        • CIL #142
      • Miami Lakes, Florida, United States, 33016
        • CIL #170
      • Miami Springs, Florida, United States, 33166
        • CIL #204
      • Ormond Beach, Florida, United States, 32174
        • CIL #185
      • Pinellas Park, Florida, United States, 33781
        • CIL #110
      • Saint Petersburg, Florida, United States, 33716
        • CIL #176
      • Sanford, Florida, United States, 32771
        • CIL #227
      • Tampa, Florida, United States, 33607
        • CIL #152
      • Tampa, Florida, United States, 33634
        • CIL #144
    • Georgia
      • Newnan, Georgia, United States, 30263
        • CIL #116
      • Savannah, Georgia, United States, 31406
        • CIL #143
    • Indiana
      • New Albany, Indiana, United States, 47150
        • CIL #175
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • CIL #191
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • CIL #228
      • Richmond, Kentucky, United States, 40475
        • CIL #194
    • Louisiana
      • Monroe, Louisiana, United States, 71203
        • CIL #219
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • CIL #145
    • Michigan
      • Bay City, Michigan, United States, 48706
        • CIL #155
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • CIL #220
    • Nebraska
      • Norfolk, Nebraska, United States, 68701
        • CIL #148
      • Omaha, Nebraska, United States, 68144
        • CIL #206
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • CIL #202
    • New York
      • New York, New York, United States, 10024
        • CIL #197
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • CIL #196
      • Raleigh, North Carolina, United States, 27612
        • CIL #192
      • Salisbury, North Carolina, United States, 28144
        • CIL #221
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • CIL #169
    • Oregon
      • Gresham, Oregon, United States, 97030
        • CIL #237
    • Pennsylvania
      • Broomall, Pennsylvania, United States, 19008
        • CIL #137
      • Hershey, Pennsylvania, United States, 17033
        • CIL #147
      • Philadelphia, Pennsylvania, United States, 19103
        • CIL #178
    • Texas
      • Austin, Texas, United States, 78735
        • CIL #160
      • Austin, Texas, United States, 78759
        • CIL #183
      • Bryan, Texas, United States, 77802
        • CIL #184
      • Channelview, Texas, United States, 77530
        • CIL #163
      • Dallas, Texas, United States, 75230
        • CIL #165
      • Houston, Texas, United States, 77030
        • CIL #167
      • Plano, Texas, United States, 75024
        • CIL #223
      • San Antonio, Texas, United States, 78229
        • CIL #159
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • CIL #105
      • Norfolk, Virginia, United States, 23507
        • CIL #231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SB204 4%
SB204 4% topically once daily
Drug: SB204 4%
Applied topically once daily
Other Names:
  • NVN1000
Placebo Comparator: Vehicle Gel
Vehicle Gel topically once daily
Drug: Vehicle Gel
Applied topically one daily
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Absolute Change From Baseline in Inflammatory Lesion Counts
Time Frame: Baseline and Week 12
The absolute change from Baseline in inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Inflammatory lesions included papules, pustules, nodules, and cysts.
Baseline and Week 12
Absolute Change From Baseline in Non-inflammatory Lesion Counts
Time Frame: Baseline and Week 12
The absolute change from Baseline in non-inflammatory lesion counts was to be assessed on the face only (forehead, right and left cheeks, chin, and nose). Non-inflammatory lesions included open comedones (blackheads) and closed comedones (whiteheads).
Baseline and Week 12
Proportion of Subjects With Investigator Global Assessment (IGA) Success at Week 12
Time Frame: Week 12

Proportion of subjects with Investigator Global Assessment (IGA) Success at Week 12 is defined as an IGA score of 0 or 1 (Clear/Almost Clear) and at least a 2 grade improvement from Baseline. The IGA scale is as follows:

Grade Description 0 Clear: Clear skin with no inflammatory or non-inflammatory lesions.

  1. Almost clear: Rare non-inflammatory lesions with rare papules (papules may be resolving and hyperpigmented, though not pink-red).
  2. Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions.
  3. Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one nodulocystic lesion.
  4. Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodulocystic lesions
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change in Inflammatory Lesion Count
Time Frame: Baseline and Week 12
The percent change from baseline in inflammatory lesion count
Baseline and Week 12
Percent Change in Non-inflammatory Lesion Count
Time Frame: Baseline and Week 12
The percent change from baseline in non-inflammatory lesion count
Baseline and Week 12
Time to Reduction in Inflammatory Lesion Count
Time Frame: Week 12
Median time to a 35% reduction (improvement) in inflammatory lesion count (Kaplan-Meier analysis)
Week 12
Time to Improvement in IGA
Time Frame: Week 12
Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis)
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novan, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chiltern International Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Joyce Rico, MD, Novan, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2016

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NI-AC302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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