A Bioavailability Study of DFD-03 Compared to Tazorac® in Patients With Moderate Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Tazarotene Lotion, 0.1%; Tazarotene Cream, 0.1%
Intervention description: DFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off; Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours
Intervention MeSH terms: Nicotinic Acids; Tazarotene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: Tazarotene and tazarotenic acid plasma concentrations will be determined at a designated laboratory from the blinded samples using a validated bioanalytical method.
Enrollment: 58.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      This was a multicenter, randomized, multiple-dose, laboratory-blinded, open-label, 2-arm,
      parallel-arm study in subjects with moderate acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject understands the study procedures, is willing to comply with the study
             procedures and required visits, and agrees to participate by giving written informed
             consent. Subjects under the legal age of consent must provide written assent and must
             have the written informed consent of their legal guardian.

          2. Subject (or legal guardian) must be willing to authorize use and disclosure of
             protected health information collected for the study.

          3. Male or female at least 9 years of age for the DFD-03 (Test) group and at least 12
             years of age for the Tazorac Cream (Reference) group.

          4. Female subjects must be having their menstrual period at Baseline (Day 1, 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.

          5. A clinical diagnosis of facial acne vulgaris with a facial Investigator's Global
             Assessment (IGA) score of 3 (moderate) at Baseline (Day 1).

          6. Subjects should have acne lesions on at least 1 of the following regions at the
             Screening visit: neck, upper chest, upper back (including shoulders).

             • This criterion is not applicable to the 9-11 years and 11 months age group.

          7. Inflammatory lesion count (papules and pustules) of at least 20 on the face, including
             the nose, at Baseline (Day 1).

             • This criterion is not applicable to the 9-11 years and 11 months age group.

          8. Non-inflammatory lesion count (closed and open comedones) of at least 25 on the face,
             including the nose, at Baseline (Day 1).

             • This criterion is not applicable to the 9-11 years and 11 months age group.

          9. No more than 2 nodulocystic lesions on the face, including the nose, at Baseline (Day
             1).

         10. Females, regardless of childbearing potential:

               1. Must have a negative serum pregnancy test at Screening and a negative urine
                  pregnancy test at Baseline (Day 1). Urine pregnancy test must have a sensitivity
                  of at least 25 mIU/mL for βhCG.

               2. If sexually active, must be on or use an acceptable method of birth control.
                  Acceptable methods of birth control include hormonal methods* or intrauterine
                  device in use ≥ 90 days prior to Baseline (Day 1); or partner has had a vasectomy
                  at least 90 days prior to Baseline (Day 1); or barrier methods plus spermicide;
                  or Essure® that has been in place for at least 3 months before the screening
                  visit with radiograph confirmation of fallopian tube blockage.

                    -  Hormonal methods: If on hormonal contraceptives, must have been on the same
                       hormonal contraceptive product for 3 months (90 days) prior to Baseline (Day
                       1) and continued on same method and dose throughout the duration of the
                       study. If subject had used hormonal birth control and had stopped, this
                       should have occurred more than 6 months prior to Baseline.

             Exception: Sexually inactive female subjects are not required to practice a reliable
             method of contraception and may be enrolled at the investigator's discretion if they
             are counseled to remain sexually inactive for the duration of the study and understand
             the possible risks involved in getting pregnant during the study. An abstinent female
             must agree that if she becomes sexually active during the study she will use an
             acceptable form of contraception such as a barrier method with spermicide.

         11. 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. Subjects should continue to use these investigator-approved products for the
             duration of the study and should avoid any changes in these consumer products.

         12. 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 direct sunlight exposure time, and have no tanning
             bed use or use of other UV light sources during participation in the study.

         13. 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 (other retinoids, antibiotics, benzoyl peroxide, azelaic
                  acid, resorcinol, salicylates, α-hydroxy/glycolic acid), or other topical facial
                  medication (antifungals, steroids, anti-inflammatories) on the treatment area in
                  the 14 days prior to Baseline (Day 1), including prescription and
                  non-prescription products.

               2. Systemic corticosteroids, systemic acne treatments including systemic antibiotics
                  used for treatment of acne, potential photosensitizing agents (thiazides,
                  phenothiazines), spironolactone, flutamide, or immunosuppressant drugs in the 30
                  days prior to Baseline (Day 1).

               3. Systemic retinoid use (including high-dose vitamin A > 10,000 units per day) in
                  the 180 days prior to Baseline (Day 1).

               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 Baseline (Day 1). 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
                  Baseline (Day 1).

          3. Known allergic reaction to retinoids or tazarotene or any of the other ingredients of
             these products. The inactive ingredients are sodium lauryl sulphate, stearyl alcohol,
             cetyl alcohol, gluconolactone, Vitamin E polyethylene glycol succinate, glycerin,
             carbomer P 971, propylparaben, methylparaben, edetate disodium, butylated
             hydroxytoluene, medium-chain triglyceride, trolamine, and purified water.

          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. Excessive facial hair (i.e., heavy beard or mustache), facial tattoos, or facial
             disfigurement, excessive hair on the neck, upper chest, shoulders and upper back
             region that would interfere with study assessments.

          6. 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 prior to Baseline (Day 1).

          8. Subjects who have been in another investigational trial within 30 days of Baseline
             (Day 1).

          9. Subjects may not have a personal relationship with any member of the study staff or be
             part of the staff at the medical practice.

         10. HIV Ag/Ab Combo, Hepatitis B (HBsAg (B)) and Hepatitis C (anti-HCV (C)) positive
             subjects.