Back to resultsA Study Comparing Tazarotene Cream 0.1% to Tazorac® and Both to a Placebo Control in the Treatment of Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tazarotene Cream 0.1%
Tazorac®
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Tazarotene Cream 0.1%
Tazorac®
Placebo
Arm Description
Tazarotene Cream 0.1% (Taro Pharmaceuticals Inc.)
Tazorac® (tazarotene cream 0.1%) (Allergan LLC)
Placebo (Vehicle of the test product) (Taro Pharmaceuticals Inc.)
Outcomes
Primary Outcome Measures
Change in inflammatory lesion counts
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Change in non-inflammatory lesion counts
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
Secondary Outcome Measures
Clinical response of success
The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02411955
Brief Title
A Study Comparing Tazarotene Cream 0.1% to Tazorac® and Both to a Placebo Control in the Treatment of Acne Vulgaris
Official Title
A Multiple-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to Tazorac® (Tazarotene Cream 0.1%) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1077 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tazarotene Cream 0.1%
Arm Type
Experimental
Arm Description
Tazarotene Cream 0.1% (Taro Pharmaceuticals Inc.)
Arm Title
Tazorac®
Arm Type
Active Comparator
Arm Description
Tazorac® (tazarotene cream 0.1%) (Allergan LLC)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (Vehicle of the test product) (Taro Pharmaceuticals Inc.)
Intervention Type
Drug
Intervention Name(s)
Tazarotene Cream 0.1%
Other Intervention Name(s)
Tazarotene
Intervention Description
Tazarotene Cream 0.1% applied to lightly cover the entire face once daily for 84 consecutive days.
Intervention Type
Drug
Intervention Name(s)
Tazorac®
Other Intervention Name(s)
Tazarotene
Intervention Description
Tazorac® applied to lightly cover the entire face once daily for 84 consecutive days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle
Intervention Description
Placebo (vehicle of the test product) applied to lightly cover the entire face once daily for 84 consecutive days.
Primary Outcome Measure Information:
Title
Change in inflammatory lesion counts
Description
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Time Frame
Week 12
Title
Change in non-inflammatory lesion counts
Description
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Clinical response of success
Description
The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catawba Research
Organizational Affiliation
http://catawbaresearch.com/contact/
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study Comparing Tazarotene Cream 0.1% to Tazorac® and Both to a Placebo Control in the Treatment of Acne Vulgaris
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