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

F

Fougera Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Acne Vulgaris

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT02886715
0454 (Other Identifier)
0454-01-01

Details and patient eligibility

About

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

Enrollment

1,110 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.
  • 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

1,110 participants in 3 patient groups, including a placebo group

Test
Experimental group
Description:
Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
Treatment:
Drug: Tazarotene Cream 0.1%
Reference
Active Comparator group
Description:
TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
Treatment:
Drug: Tazorac®
Placebo
Placebo Comparator group
Description:
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

25

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Data sourced from clinicaltrials.gov

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