Trial intelligence / Profile preview

Generic Tazarotene Foam vs Fabior in Acne Vulgaris

NCT02267746Phase 3

Key facts

Status
Completed
Start
Jun 2014
Primary completion
Sep 2014
Countries
2
Sponsor
Allergan
Modality
Orthosteric Ligands
Conditions
acne vulgaris
01

Overview

Phase 3, randomised, double-blind trial of tazarotene in acne vulgaris (3 arms), sponsored by Allergan. Primary endpoints: Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts at 12 weeks and Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts at 12 weeks. Started Jun 2014; status: completed.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • Fabior™(tazarotene)

    Reference listed drug: Fabior™ 0.1% foam

  • Tazarotene (Actavis)

    Generic Tazarotene 0.1% foam

  • Vehicle foam

    Placebo foam vehicle

03

Who it enrols

Patients aged 12-40 with acne vulgaris, having >=30 non-inflammatory and >=25 inflammatory lesions, and an IGA score of 3 or 4.

04

Endpoints

Primary

  • Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts

  • Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts

Secondary

  • Proportion of Subjects With an IGA Score That is at Least 2 Grades Less Than the Baseline Assessment

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