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
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: DFD-03 Lotion, 0.1%; Tazorac Cream, 0.1%; DFD-03 Vehicle Lotion 0%; Tazorac Vehicle Cream 0%
Intervention description: 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.; Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.; 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.; Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.
Intervention MeSH terms: Nicotinic Acids; Tazarotene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 155.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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).

          2. 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.

          3. 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.

          4. 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.

          5. 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.

          6. 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.

          7. 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:

          1. Females who are pregnant or lactating or planning to become pregnant during the study
             period.

          2. 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.

          3. Known allergic reaction to retinoids or tazarotene or any of the product ingredients.

          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.

          6. Subjects who have been treated for alcohol dependence or alcohol or drug abuse in the
             year.