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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up mean percent change from baseline to week 12
Awards & highlights
Summary
The purpose of this study is to compare the safety and therapeutic equivalence of a generic tazarotene foam 0.1% and the reference listed Fabior™ (tazarotene foam, 0.1%) in the treatment of acne vulgaris.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ mean percent change from baseline to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~mean percent change from baseline to week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts
Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts
Side effects data
From 2014 Phase 3 trial • 893 Patients • NCT022677464%
Headache
2%
Nasopharyngitis
2%
Dysmenorrhoea
1%
Skin exfoliation
1%
Diarrhoea
1%
Influenza
1%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Test
Vehicle
Reference
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: TazaroteneExperimental Treatment1 Intervention
Tazarotene 0/1% foam (Actavis)
Group II: Fabior™(tazarotene)Active Control1 Intervention
Reference listed drug: Fabior™ 0.1% foam (Stiefel)
Group III: Vehicle foamPlacebo Group1 Intervention
Foam vehicle of the test product (Actavis)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazarotene
FDA approved
Find a Location
Who is running the clinical trial?
Actavis Inc.Lead Sponsor
98 Previous Clinical Trials
24,354 Total Patients Enrolled
1 Trials studying Acne
1,001 Patients Enrolled for Acne
Keri WinklerStudy DirectorAkesis, LLC
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