A Study of the Safety and Efficacy of DFD-03 for the Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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Enrollment of subjects with mild to moderate facial acne. Efficacy was assessed by using an Investigator's Global Assessment scale (IGA 5 point scale) and by counting the number of inflammatory and non-inflammatory lesions on the face at Baseline and Weeks 4, 8, and 12. Safety assessments included the investigator's assessment of local cutaneous tolerance of the treated skin (dryness, non-lesional erythema, peeling, stinging, burning, and itching, vital signs, and adverse events (AEs).

Detailed Description
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Enrollment of subjects with mild to moderate facial acne. Subjects with acne lesions of any severity on the chest and/or back (including shoulders) were enrolled provided they had mild to moderate acne on the face. During the 12-week treatment period subjects used the study product twice daily. Subjects were instructed to treat the entire face (and chest and/or back including shoulders, if applicable). Efficacy was assessed by using an Investigator's Global Assessment scale (IGA 5 point scale) and by counting the number of inflammatory and non-inflammatory lesions on the face at Baseline and Weeks 4, 8, and 12. Safety assessments included the investigator's assessment of local cutaneous tolerance of the treated skin (dryness, non-lesional erythema, peeling, stinging, burning, and itching; assessed separately on the chest and/or back including shoulders (if applicable), vital signs (blood pressure and pulse rate), and adverse events (AEs). Urine pregnancy tests were performed at Baseline and at every visit through Week 12 for all female subjects. A physical examination was performed.

Official Title
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A Multicenter, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: DFD-03
* Other: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Subject must be at least 9 years of age. A clinical diagnosis of mild to moderate facial acne vulgaris. Inflammatory lesion count (papules and pustules) of at least 20 on the face, Non-inflammatory lesion count (closed and open comedones) of at least 25 on the face and No more than 2 nodulocystic lesions on the face. Females, regardless of childbearing potential, if sexually active, must be on or use an acceptable method of birth control. Subject must be in good general health as determined by the investigator and supported by medical history, physical and Vital Signs exam. Main Exclusion Criteria: Females who are pregnant or lactating or planning to become pregnant. Treatment with the following products: Topical acne treatments or other topical facial medication on the treatment area. Systemic corticosteroids, systemic acne treatments including systemic antibiotics used for treatment of acne. Systemic retinoid use. 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). 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 the 30 days. Known allergic reaction to retinoids or tazarotene. 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 in another investigational trial within 30 days.

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: Active<br>DFD-03 (0.1% tazarotene) Lotion | Drug: DFD-03<br>* DFD-03 Lotion<br>* Other names: Tazarotene 0.1% Lotion;|
| Placebo Comparator: Vehicle<br>Vehicle (0% tazarotene) Lotion | Other: Placebo Comparator<br>* Vehicle (tazarotene 0%) Lotion<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change in the Inflammatory Lesion Counts on the Face | Change in inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using a two way analysis of covariance (ANCOVA) model | Baseline to Week 12 | 
| Absolute Change in the Non-inflammatory Lesion Counts on the Face | Change in non-inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using the same ANCOVA model | Baseline to Week 12 | 
| Proportion of Subjects With Treatment Success Based on IGA Score | IGA success at Week 12 (an IGA score of 0 (Clear) or 1 (almost clear) with at least a 2-grade reduction from baseline) - will be analyzed using the Cochran-Mantel-Haenszel (CMH) test for general association | Baseline to Week 12 |