Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Clindamycin + BPO; Azelaic acid
Intervention description: Gel containing 1.2% clindamycin and 3% BPO for once daily application; Cream containing 20% azelaic acid for twice daily application
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Azelaic acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 222.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: azelaic acid; Clindamycin; Benzoyl peroxide; Acne vulgaris

Summary:

      This is a randomized, comparator-controlled, single-blind, parallel-group study. The current
      study proposes to compare a fixed-dose combination product containing 3% benzoyl peroxide
      (BPO) and 1% clindamycin against a cream containing 20% azelaic acid for the treatment of
      facial acne vulgaris. The results of the study will enable a better assessment of the safety
      and efficacy of the new dose regime (BPO 3% + clindamycin 1%) in comparison to a well
      established treatment. Based on the data more evidence based recommendations will be possible
      to improve the treatment of subjects with acne vulgaris. A total of 220 subjects will be
      enrolled and will have 5 study visits (Day 1, Weeks 2, 4, 8 and 12). The duration of the
      study will be over 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are males or females 12 to 45 years of age, inclusive.

          -  Subjects with acne vulgaris who have: a minimum of 17 to a maximum of 60 inflammatory
             facial lesions (papules and pustules), including the nose, and no more than 1 facial
             nodular cystic lesions and a minimum of 20 to a maximum of 125 non-inflammatory facial
             lesions (open and closed comedones) and an ISGA score of 2 or 3.

          -  Subjects agreeing not to use sun-beds or undergo any ultraviolet (UV) light treatment
             for 4 weeks prior to entering the study and to minimize the amount of exposure to
             direct sunlight for the duration of the study.

          -  Subjects who are capable of understanding and willing to provide signed and dated
             written voluntary informed consent before any protocol-specific procedures are
             performed. Subjects under the legal age of consent must provide assent and have the
             written, informed consent of both parents or legal guardians.

        Exclusion Criteria:

          -  Unable to comply with the requirement of the study.

          -  Female subjects who are pregnant, breast-feeding, or sexually active and not using
             reliable contraception and/or not prepared to do so for the duration of the trial (a
             negative pregnancy test must be confirmed at Visit 1, 3, 4 and 5, for all females if
             menarche has occurred).

          -  Subjects who have any clinically relevant finding at their baseline physical
             examination or medical history such as severe systemic diseases or diseases of the
             facial skin other than acne vulgaris.

          -  Subjects who have facial hair that may obscure the accurate assessment of acne grade.

          -  Subjects who have a history or presence of regional enteritis or inflammatory bowel
             disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a
             history of antibiotic-associated colitis) or similar symptoms.

          -  Prior Therapy: Have received treatment with the following therapies at the times
             specified prior to Baseline: systemic retinoids [6 months]; systemic antibiotics,
             investigational therapy, facial procedure (chemical or laser peel, microdermabrasion,
             artificial UV therapy), topical corticosteroids on the face or systemic
             corticosteroids [4 weeks]; topical antibiotics on the face, topical anti-acne
             medications (eg, BPO, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide
             sodium and derivatives, glycolic acid) [2 weeks]; medications that are reported to
             exacerbate acne (eg, mega-doses of certain vitamins such as vitamin D, vitamin A, and
             vitamins B2, B6, and B12; haloperidol; halogens such as iodide and bromide; lithium;
             hydantoin; and phenobarbital) as these may impact efficacy assessments, neuromuscular
             blocking agents (Clindamycin has neuromuscular blocking activities, which may enhance
             the action of other neuromuscular blocking agents), drugs known to be photosensitizers
             (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because
             of the possibility of increased phototoxicity [1 day].

          -  Subjects who are unwilling to stop using the following types of facial products during
             the study: astringents, toners, abradants, facials, peels containing glycolic or other
             acids, masks, washes or soaps containing BPO, sulfacetamide sodium or salicylic acid,
             non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or
             alpha- or beta-hydroxy acids.

          -  Subjects who have a known hypersensitivity or previous allergic reaction to any of the
             active components (azaleic acid, lincomycin, clindamycin, BPO), or excipients of the
             study medication.

          -  Use of estrogens, including oral, implanted, and topical contraceptives, androgens, or
             anti-androgenic agents of less than 12 consecutive weeks prior to start of study
             dosing (change of the dose or drug is not permitted between 12 weeks prior study
             dosing until end of the study).