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Completed

NCT Number: NCT02242760

P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris

This is a randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.

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Key information

Conditions

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

Age range

12 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Qst acne site #1, Hot Springs, Arkansas, United States

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About this study

A randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Moderate to severe acne
  • 25-70 non-inflammatory lesions at Baseline
  • 20-40 inflammatory lesions at Baseline

Exclusion criteria

  • Subjects with known allergy to any component of the test material or vehicle
  • Women who are pregnant or nursing

Treatment and study plan

SB204 2%

Drug

Applied topically twice daily

Other names: NVN1000

SB204 4%

Drug

Applied topically daily

Other names: NVN1000

Vehicle gel

Drug

Applied topically twice and once daily

Other names: Placeco

Primary outcomes

  1. Absolute Change in Inflammatory Lesion Counts

    Time frame: Baseline and Week 12

    Change in inflammatory lesion count from Baseline to Week 12

  2. Absolute Change in Non-inflammatory Lesion Counts

    Time frame: Baseline and Week 12

    Absolute Change in non-inflammatory lesion count from Baseline to Week 12

  3. Proportion of Success According to the Dichotomized Investigator Global Assessment [IGA] at End of Treatment

    Time frame: Baseline and Week 12

    Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline. The IGA was a static assessment. The assessment was made with the evaluator approximately 3 feet away from the subject; the IGA assessment was to be done prior to the lesion counts. A lower grade is considered to be a better outcome.

    Grade 0 = clear (clear skin with no inflammatory or non-inflammatory lesions) Grade 1 = almost clear (few non-inflammatory lesions with no more than rare papules (papules may be resolving and hyperpigmented, though not pink-red) Grade 2 = mild (some non-inflammatory lesions with no more than a few inflammatory lesions) Grade 3 = moderate (up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 nodular lesion) Grade 4= severe (up to many non-inflammatory and inflammatory lesions, including nodular lesions)

Secondary outcomes

  1. Percent Change in Inflammatory Lesion Count From Baseline to Week 12

    Time frame: Baseline and Week 12

    The percent change in inflammatory lesion count from Baseline to Week 12

  2. Percent Change in Non-inflammatory Lesion Count From Baseline to Week 12

    Time frame: Baseline and Week 12

    The percent change in non-inflammatory lesion count from Baseline to Week 12

  3. Median Time to Improvement

    Time frame: Baseline through Week 12

    Median time to a 35% improvement in inflammatory lesion counts (Kaplan-Meier estimate). The full range values presented below are estimates made from the Kaplan-Meier figure.

Sponsors and collaborators

Lead sponsor

Novan, Inc.

Industry

Registry information

Official study title

A Phase 2, Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled Study Comparing the Efficacy, Tolerability, and Safety of SB204 Gel and Vehicle Gel Once or Twice Daily in the Treatment of Acne Vulgaris

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 17, 2014
Registry last updated
May 31, 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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