A Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: DFD-03 (0.1% tazarotene) Lotion; DFD-03 (0% tazarotene) Lotion (Placebo)
Intervention description: DFD-03 Lotion (0.1% tazarotene) - twice daily application; DFD-03 Vehicle Lotion (0% tazarotene) - twice daily application
Intervention MeSH terms: Nicotinic Acids; Tazarotene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 547.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      Enrollment of subjects with mild to moderate facial acne vulgaris.

      Co-Primary efficacy endpoints included:

        -  Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face

        -  Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the
           face

        -  Proportion of subjects with a clinical response of "success" at Week 12 for lesions on
           the face. Success based on IGA is defined as an IGA score of 0 (Clear) or 1 (Almost
           clear) at Week 12 with at least a 2-grade reduction from Baseline.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject must be at least 9 years of age.

          2. Female subjects must be having their period at the Baseline Visit (as reported by the
             subject), except for subjects using hormonal contraceptives that preclude menstrual
             periods, if the subject is premenarcheal, is postmenopausal for at least 12 months
             prior to baseline, is surgically sterilized (i.e. tubal ligation) or if the subject is
             without a uterus and /or both ovaries.

          3. A clinical diagnosis of facial mild to moderate acne vulgaris. Subjects with acne
             lesions on the chest and/or back (including shoulders) in addition to those on the
             face have the option of treating their back and/or chest (including shoulders) in
             addition to their face.

          4. Inflammatory lesion count (papules and pustules) of at least 20 on the face, and
             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 on the face, including the
             nose.

          5. 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.

          6. Subjects must be willing to comply with sun avoidance measures for the face (as well
             as back/chest and shoulders, if applicable) including use of investigator-approved
             sunscreen and/or hats, have limited sun exposure time, and have no tanning bed use.

          7. Subject must be in good general health as determined by the investigator and supported
             by the medical history, physical examination, and normal or not clinically significant
             abnormal vital signs (blood pressure and pulse).

        Exclusion Criteria:

          1. Females who are pregnant or lactating or planning to become pregnant during the study
             period.

          2. Treatment with the following products:

               1. Topical acne treatments or other topical facial medication on the treatment area
                  in the 14 days prior to the Baseline Visit, including prescription and
                  non-prescription products.

               2. Systemic corticosteroids, systemic acne treatments including systemic antibiotics
                  used for treatment of acne, potential photosensitizing agents spironolactone,
                  flutamide, or immunosuppressant drugs in the 30 days prior to the Baseline Visit.

               3. Systemic retinoid use in the 180 days prior to the Baseline Visit.

               4. 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 the 30 days prior to the Baseline Visit. After the subject is
                  enrolled in the study, eyebrow shaping (except for tweezing) is prohibited.

               5. 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.

               6. Treatment with an investigational product or device in the 30 days prior to the
                  Baseline Visit.

          3. Known allergic reaction to retinoids or tazarotene or any of the other ingredients of
             these products.

          4. 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.

          5. 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.

        7. Subjects who have been treated for alcohol dependence or alcohol or drug abuse in the
        year.

        8. Subjects who have been in another investigational trial within 30 days.