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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|ClinicalTrials.gov Identifier: NCT02411955|
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : May 4, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: Tazarotene Cream 0.1% Drug: Tazorac® Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1077 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||June 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||February 2015|
Experimental: Tazarotene Cream 0.1%
Tazarotene Cream 0.1% (Taro Pharmaceuticals Inc.)
Drug: Tazarotene Cream 0.1%
Tazarotene Cream 0.1% applied to lightly cover the entire face once daily for 84 consecutive days.
Other Name: Tazarotene
Active Comparator: Tazorac®
Tazorac® (tazarotene cream 0.1%) (Allergan LLC)
Tazorac® applied to lightly cover the entire face once daily for 84 consecutive days.
Other Name: Tazarotene
Placebo Comparator: Placebo
Placebo (Vehicle of the test product) (Taro Pharmaceuticals Inc.)
Placebo (vehicle of the test product) applied to lightly cover the entire face once daily for 84 consecutive days.
Other Name: Vehicle
- Change in inflammatory lesion counts [ Time Frame: Week 12 ]Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
- Change in non-inflammatory lesion counts [ Time Frame: Week 12 ]Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
- Clinical response of success [ Time Frame: Week 12 ]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
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|Ages Eligible for Study:||12 Years to 40 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411955
|Study Chair:||Catawba Research||http://catawbaresearch.com/contact/|
|Responsible Party:||Taro Pharmaceuticals USA|
|Other Study ID Numbers:||
|First Posted:||April 8, 2015 Key Record Dates|
|Last Update Posted:||May 4, 2017|
|Last Verified:||May 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
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