A Study of the Safety and Efficacy of DFD-03 for the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: DFD-03; Placebo Comparator
Intervention description: DFD-03 Lotion; Vehicle (tazarotene 0%) Lotion
Intervention MeSH terms: 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: 550.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility criteria:

        Main Inclusion Criteria:

          1. Subject must be at least 9 years of age.

          2. A clinical diagnosis of mild to moderate facial acne vulgaris.

          3. 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.

          4. Females, regardless of childbearing potential, if sexually active, must be on or use
             an acceptable method of birth control.

          5. 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:

          1. Females who are pregnant or lactating or planning to become pregnant.

          2. Treatment with the following products:

               1. Topical acne treatments or other topical facial medication on the treatment area.

               2. Systemic corticosteroids, systemic acne treatments including systemic antibiotics
                  used for treatment of acne.

               3. Systemic retinoid use.

               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).

               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.

          3. Known allergic reaction to retinoids or tazarotene.

          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 in another investigational trial within 30 days.