Acne Vulgaris
Conditions
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.
Interventions
Tazarotene Cream 0.1% applied to lightly cover the entire face once daily for 84 consecutive days.
DRUGTazorac®
Tazorac® applied to lightly cover the entire face once daily for 84 consecutive days.
DRUGPlacebo
Placebo (vehicle of the test product) applied to lightly cover the entire face once daily for 84 consecutive days.
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in inflammatory lesion counts | Week 12 | Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts |
| Change in non-inflammatory lesion counts | Week 12 | Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response of success | 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 |
Outcome results
None listed