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

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: Tazorac®; Drug: Placebo; Drug: Tazarotene Cream 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02411955

TAZC 1308

Details and patient eligibility

About

The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%).

Full description

The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%) in the treatment of acne vulgaris and to demonstrate the superiority of the test and reference products over the placebo control.

Enrollment: 1,077 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
• Subjects aged 18 years and older must have provided written consent. Subjects aged 12 to 17 years must have provided written assent accompanied by written consent from their legally acceptable representative. All subjects or their legally acceptable representatives must sign Health Insurance Portability and Accountability Act authorization.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,077 participants in 3 patient groups, including a placebo group

Tazarotene Cream 0.1%

Experimental group

Description:

Tazarotene Cream 0.1% (Taro Pharmaceuticals Inc.)

Treatment:

Drug: Tazarotene Cream 0.1%

Tazorac®

Active Comparator group

Description:

Tazorac® (tazarotene cream 0.1%) (Allergan LLC)

Treatment:

Drug: Tazorac®

Placebo

Placebo Comparator group

Description:

Placebo (Vehicle of the test product) (Taro Pharmaceuticals Inc.)

Treatment:

Drug: Placebo