A Study to Assess the Safety and Local Tolerability of DFD-03 (Tazarotene) Lotion, 0.1% Compared to Tazorac® Cream, 0.1% in the Topical Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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A study for Subjects with mild to moderate facial acne vulgaris. During the 12-week treatment period subjects randomized to DFD-03 Lotion or Vehicle Lotion will use the study drug twice daily. Subjects randomized to Tazorac Cream or Vehicle Cream will use the study drug once daily in the evening. Safety assessments will include the investigator's assessment of local cutaneous tolerance/application site reactions on the face, vital signs and adverse events.

Detailed Description
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A study for Subjects with mild to moderate facial acne vulgaris. Subjects will be randomized to treatment with either DFD-03 (tazarotene) Lotion 0.1%, Tazorac (tazarotene) Cream, 0.1%, Vehicle Lotion or Vehicle Cream. During the 12-week treatment period subjects randomized to DFD-03 Lotion or Vehicle Lotion will use the study drug twice daily. Subjects randomized to Tazorac Cream or Vehicle Cream will use the study drug once daily in the evening. Subjects will be instructed to treat the entire face. Safety assessments will include the investigator's assessment of local cutaneous tolerance/application site reactions on the face, vital signs and adverse events. Urine pregnancy tests will be performed for all female subjects. A physical examination will be performed.

Official Title
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A Randomized, Double-Blind, Active-Controlled Study to Assess the Safety and Local Tolerability of DFD-03 (Tazarotene) Lotion, 0.1% Compared to Tazorac® (Tazarotene) Cream, 0.1% in the Topical Treatment of Acne Vulgaris for 12 Weeks

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: DFD-03 Lotion, 0.1%
* Drug: Tazorac Cream, 0.1%
* Drug: DFD-03 Vehicle Lotion 0%
* Drug: Tazorac Vehicle Cream 0%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be at least 12 years of age. At selected site(s), a total of approximately eight subjects 9-11 years of age will be enrolled into the 2 arms of DFD-03 lotion group (active and vehicle). A clinical diagnosis of facial acne vulgaris with a facial Investigator's Global Assessment (IGA) score of 2 (mild) to 3 (moderate) at Baseline. At selected site(s), up to twelve subjects with acne lesions on the chest and/or back (including shoulders) in addition to those on the face will treat their chest and/or back (including shoulders) in addition to their face. Inflammatory lesion count (papules and pustules) of at least 20, non-inflammatory lesion count (closed and open comedones) of at least 25 on the face including the nose, and no more than 2 nodulocystic lesions. This criteria is not applicable to the 9-11 years age group as long as subjects have an IGA score of 2 (mild) to 3 (moderate) at Baseline. Females, regardless of childbearing potential: Must have a negative urine pregnancy test and if sexually active, must be on or use an acceptable method of birth control. Subjects agree not to use any product on the face during the entire course of study except for non-medicated, investigator-approved cleanser, sunscreen, face wash, and make-up as instructed by the investigator. Subjects must be willing to comply with sun avoidance measures for the face, including use of investigator-approved sunscreen and/or hats, have limited sun exposure time, and have no tanning bed use. Subject must be in good general health as determined by the investigator and supported by the medical history, physical examination and vital signs. Exclusion Criteria: Females who are pregnant or lactating or planning to become pregnant during the study period. Treatment with the following products: Topical acne treatments or other topical facial medication in the 14 days prior to Baseline Systemic corticosteroids and systemic acne treatments in the 30 days prior to Baseline Systemic retinoid use in the 180 days prior to Baseline Undertaken certain facial procedures such as chemical peel, laser treatment, photodynamic therapy, acne surgery, cryodestruction or chemodestruction, x-ray therapy, intralesional steroids, dermabrasion, or depilation (except eyebrow shaping) in 30 days prior to Baseline. Treatment with a medication or procedure that, in the opinion of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with evaluations in the study. Treatment with an investigational product or device in 30 days prior to Baseline. Known allergic reaction to retinoids or tazarotene or any of the product ingredients. Presence of any facial skin disease or condition that would interfere with the study or place the subject at unacceptable risk including sunburn, rosacea, seborrheic dermatitis, perioral dermatitis, lupus, dermatomyositis, psoriasis, eczema, squamous cell carcinoma, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, bacterial folliculitis or any other facial disease or condition. Subjects with a serious and or chronic medical condition such as chronic or active liver disease, renal impairment, heart disease, severe respiratory disease, rheumatoid arthritis, current malignancies, immunocompromised conditions, or any other disease that, in the opinion of the investigator, would interfere with the study or place the subject at unacceptable risk. Subjects who have been treated for alcohol dependence or alcohol or drug abuse in the year.

Ages Eligible for Study
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Minimum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DFD-03 Lotion, 0.1%<br>DFD-03 Lotion, 0.1% to be applied twice daily approximately 12 hours apart, for 1 minute and rinsed off | Drug: DFD-03 Lotion, 0.1%<br>* DFD-03 Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.<br>* Other names: Tazarotene Lotion, 0.1%;|
| Active Comparator: Tazorac Cream, 0.1%<br>Tazorac Cream, 0.1% to be applied once in the evening and left overnight for approximately 12 hours | Drug: Tazorac Cream, 0.1%<br>* Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.<br>* Other names: Tazarotene Cream, 0.1%;|
| Placebo Comparator: Vehicle Lotion<br>Vehicle Lotion to be applied twice daily for 1 minute and rinsed off | Drug: DFD-03 Vehicle Lotion 0%<br>* Vehicle Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.<br>* Other names: Vehicle Lotion 0%;|
| Placebo Comparator: Vehicle Cream<br>Vehicle Cream to be applied once in the evening and left overnight for approximately 12 hours | Drug: Tazorac Vehicle Cream 0%<br>* Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.<br>* Other names: Vehicle Cream 0%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event Occurences in DFD-03 Lotion Versus Tazorac Cream Groups | Frequency count of treatment emergent adverse events will be compared between DFD-03 Lotion and Tazorac Cream groups. | Baseline to Week 12 |