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Completed

NCT Number: NCT02667444

P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

9 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CIL #214, Birmingham, Alabama, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SB204 4%

Drug

Applied topically once daily

Other names: NVN1000

Vehicle gel

Drug

Applied topically one daily

Other names: Placebo

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

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

Secondary outcomes

  1. Percent Change in Inflammatory Lesion Count

    Time frame: Baseline and Week 12

    The percent change from baseline in inflammatory lesion count

  2. Percent Change in Non-inflammatory Lesion Count

    Time frame: Baseline and Week 12

    The percent change from baseline in non-inflammatory lesion count

  3. 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)

  4. Time to Improvement in IGA

    Time frame: Week 12

    Median time to a 2 or more grade improvement in IGA (Kaplan-Meier analysis)

Sponsors and collaborators

Lead sponsor

Novan, Inc.

Industry

Collaborators

  • Chiltern International Inc.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 29, 2016
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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