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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

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

Key facts

Study ID

NCT02886715

Run by

Fougera Pharmaceuticals Inc.

People needed

1110

Starts

2016-09-21

Expected to finish

2017-05-31

Last updated by the study team

2018-08-17

Who can join

Age: 12 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Fougera Investigational Site — Tucson, Arizona, United States
• Fougera Investigational Site — Conway, Arkansas, United States
• Fougera Investigational Site — Hot Springs, Arkansas, United States
• Fougera Investigational Site — Anaheim, California, United States
• Fougera Investigational Site — La Mesa, California, United States
• Fougera Investigational Site — Long Beach, California, United States
• Fougera Investigational Site — Long Beach, California, United States
• Fougera Investigational Site — Los Angeles, California, United States
• Fougera Investigational Site — North Hollywood, California, United States
• Fougera Investigational Site — San Diego, California, United States
• Fougera Investigational Site — San Ramon, California, United States
• Fougera Investigational Site — Upland, California, United States
• Fougera Investigational Site — West Covina, California, United States
• Fougera Investigational Site — Coral Gables, Florida, United States
• Fougera Investigational Site — Miami, Florida, United States
• Fougera Investigational Site — Miami, Florida, United States
• Fougera Investigational Site — Miami Gardens, Florida, United States
• Fougera Investigational Site — Miramar, Florida, United States
• Fougera Investigational Site — Sweetwater, Florida, United States
• Fougera Investigational Site — Plainfield, Indiana, United States
• Fougera Investigational Site — High Point, North Carolina, United States
• Fougera Investigational Site — Hazleton, Pennsylvania, United States
• Fougera Investigational Site — Upper Saint Clair, Pennsylvania, United States
• Fougera Investigational Site — Chattanooga, Tennessee, United States
• Fougera Investigational Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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