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Completed

NCT Number: NCT02886715

A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris

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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 3

Primary location

Fougera Investigational Site, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
  • Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
  • Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Exclusion criteria

  • Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
  • Have a history of hypersensitivity or allergy to tazarotene, retinoids and/or any of the study medication ingredients.
  • Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.

Treatment and study plan

Tazarotene Cream 0.1%

Drug

Tazarotene Cream 0.1% applied to cover the affected areas of the face once daily for 84 +/- 4 days.

Other names: Tazarotene

Tazorac®

Drug

Tazorac® applied to cover the affected areas of the face once daily for 84 +/- 4 days.

Other names: Tazarotene

Placebo

Drug

Placebo (vehicle of the test product) applied to cover the affected areas of the face once daily for 84 +/- 4 days.

Other names: Vehicle

Primary outcomes

  1. Change in Inflammatory Lesion Counts

    Time frame: Week 12

    Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts

  2. Change in Non-inflammatory Lesion Counts

    Time frame: Week 12

    Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts

Secondary outcomes

  1. Clinical Response of Success

    Time frame: Week 12

    The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment

Sponsors and collaborators

Lead sponsor

Fougera Pharmaceuticals Inc.

Industry

Registry information

Official study title

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 1, 2016
Registry last updated
Aug 17, 2018

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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