A Phase 4, Single-Blind, Randomized, Study to Compare the Tolerability and Efficacy of 0.1% Tazorac Cream When Used in Combination With Either Duac Gel or Acanya Gel for the Treatment of Facial Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene; clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene
Intervention description: Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene; clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene
Intervention MeSH terms: Nicotinic Acids; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide; Tazarotene
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      A single-blind (investigator-blinded), randomized, parallel group, single center study to
      evaluate the tolerability and efficacy of combination therapy with Duac Gel / 0.1% Tazorac
      Cream and Acanya Gel / 0.1% Tazorac Cream for the treatment of facial acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of acne vulgaris.

          -  Lesion count: 20 to 50 inflammatory (papules and pustules) and 30 to 100
             noninflammatory (open and closed - comedones) facial lesions excluding nose, and ≤ 1
             small nodular lesion. Cystic lesions are not allowed at baseline.

          -  Investigator Static Global Assessment of 3 or 4 at Baseline.

        Exclusion Criteria:

          -  Clinically relevant finding at baseline or medical history of severe systemic diseases
             or diseases of the facial skin, other than acne vulgaris.

          -  Subjects with cystic acne lesions.

          -  Facial hair that may obscure the accurate assessment of acne grade.

          -  History or presence of regional enteritis or inflammatory bowel disease (eg,
             ulcerative colitis, pseudomembranous colitis, chronic diarrhea, celiac disease or a
             history of antibiotic-associated colitis) or similar symptoms.

          -  Concurrent use of medications known to be photosensitizers (eg, thiazides,
             tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the
             possibility of increased phototoxicity.

          -  Concomitant use of neuromuscular blocking agents. Clindamycin has neuromuscular
             blocking activities, which may enhance the action of other neuromuscular blocking
             agents.

          -  Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids, azelaic acid,
             resorcinol, salicylates, sulfacetamide sodium and derivatives, and glycolic acid)
             within the past 2 weeks.

          -  Use of topical antibiotics on the face within the past 2 weeks or systemic antibiotics
             within the past 4 weeks.

          -  Use of topical corticosteroids on the face or systemic corticosteroids within the past
             2 to 4 weeks, respectively. Use of inhaled, intra-articular or intra lesional (other
             than for facial acne lesions) steroids is acceptable.

          -  Use of systemic retinoids, such as Isotretinoin, within the past 6 months.

          -  Concomitant use of the following types of facial products: astringents, toners,
             abradants, hair removal wax, facials, peels containing glycolic or other acids, masks,
             washes or soaps containing benzoyl peroxide, sulfacetamide sodium or salicylic acid,
             non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or α-
             or β hydroxy acids.

          -  Concomitant use of medications that are reported to exacerbate acne, (eg, vitamins
             such as vitamin D, vitamin A, vitamins B2, B6, B12; haloperidol, halogens such as
             iodide and bromide, lithium, cyclosporine, psoralen, sirolimus, imatinib,
             aripiprazole, isoniazid, valproate acid, hydantoin, and phenobarbital) as these may
             impact efficacy assessments. Iron supplements and folate are acceptable.

          -  Facial procedures (eg, chemical peel, lasers/lights, photodynamic therapy,
             microdermabrasion, artificial ultraviolet therapy) performed by an esthetician,
             beautician, physician, nurse, or other practitioner, within the past 4 weeks.

          -  Known hypersensitivity or previous allergic reaction to any component(s) or
             excipient(s) of the study products.

          -  Use of any investigational medications or treatments within the past 4 weeks.

          -  Treatment with estrogens, including oral, implanted and topical contraceptives,
             androgens, or anti-androgenic agents for 12 weeks or less immediately prior to
             starting study product and have not been prescribed for the treatment of Acne
             Vulgaris. Subjects that have been treated with estrogens, as described above,
             androgens, or anti androgenic agents for more than 12 consecutive weeks prior to start
             of study treatment are allowed to enroll as long as they do not expect to change dose,
             medication, or discontinue use during the study.

          -  Evidence of recent alcohol or drug abuse (in the opinion of the investigator).

          -  Live in the same household as currently enrolled subjects.

          -  Employee of the investigator, a clinical research organization, or Stiefel
             Laboratories who is involved in the study or an immediate family member (eg, partner,
             offspring, parents, siblings or sibling's offspring) of an employee involved in the
             study.