DUAC® Early Onset Efficacy Study in Japanese Subjects
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Duac® fixed dose combination gel; ADA 0.1% gel; CLDM 1% gel
Intervention description: Duac® fixed dose combination gel containing clindamycin phosphate 1.2% and benzoyl peroxide 3%.; ADA 0.1% gel containing 0.1% of adapalene.; CLDM 1% gel containing clindamycin phosphate 1.2% (1% as clindamycin).
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 350.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Clindamycin; Gel; Benzoyl Peroxide; Acne Vulgaris

Summary:

      This is a multicentre, randomized, single-blind (investigator is blinded), active (the
      combination therapy of adapalene [ADA] and clindamycin [CLDM])-controlled and parallel-group
      study in Japanese subjects with facial acne vulgaris. The purpose of this study is to
      evaluate the efficacy, safety and tolerability of CLDM 1 percent (%)-benzoyl peroxide 3%
      (Duac®: trademark owned by GlaxoSmithKline) once daily fixed dose combination gel versus
      combination therapy of ADA 0.1% gel and CLDM 1% gel in the topical treatment of facial acne
      vulgaris for 12 weeks. A total of 400 subjects will be screened for enrolment. Subjects will
      use Duac® fixed dose combination gel with quantity sufficient to cover entire face (including
      the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) or combination
      therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including the
      forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice
      daily, once in the morning and once in the evening (at bedtime) for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects between 12 to 45 years of age, inclusive.

          -  Subjects must have had both: (a) A minimum of 17 but not more than 60 ILs (papules /
             pustules) on the face, including nasal lesions; (b) A minimum of 20 but not more than
             150 non-ILs (open / closed comedones) on the face, including nasal lesions.

          -  Subjects who have an ISGA score of 2 or greater at Baseline.

          -  Female subjects of childbearing potential and women who are less than 2 years from
             their last menses must agree to use contraception

          -  Subjects who are willing and able to follow all study procedures and to visit all
             scheduled evaluation points.

          -  Subjects who have ability to understand and give a written informed consent form
             (written informed consent must be obtained also from the parent or guardian if the
             participant is under 20 years of age).

        Exclusion Criteria:

          -  Subjects who have any nodulo-cystic lesions at Baseline.

          -  Female subjects who are pregnant or who are breast-feeding.

          -  Subjects who have a history or presence of regional enteritis, inflammatory bowel
             disease (e.g. ulcerative colitis, pseudomembranous colitis, chronic diarrhoea,
             antibiotic-associated colitis or bloody diarrhoea) or similar symptoms.

          -  Subjects who used any of the following agents within 2 weeks prior to Baseline:
             topical antibiotics on the face or systemic antibiotics; topical anti-acne medications
             (e.g. Benzoyl peroxide, azelaic acid, resorcinol, salicylates etc.); abradants,
             facials, peels, masks containing glycolic or other acids; washes, soaps, non mild
             facial cleansers containing benzoyl peroxide, salicylic acid or sulfacetamide sodium;
             moisturizers containing retinol, salicylic acid or alpha or beta-hydroxy acids (except
             additive agent); astringents and toner.

          -  Subjects who used any of the following agents on the face or performed the following
             procedure within 4 weeks prior to baseline: topical corticosteroids applied onto face
             (use of inhaled, intra-articular or intra-lesional steroids other than for facial acne
             is acceptable); facial procedure (such as chemical and laser peel, microdermabration,
             blue light treatment, etc.).

          -  Subjects who used systemic retinoids within the previous 6 months or topical retinoids
             within 6 weeks prior to Baseline.

          -  Subjects who received treatment with estrogens, androgens or anti-androgenic agents
             within the previous 12 weeks (subjects who have been treated with the above agents for
             more than 12 consecutive weeks prior to start of investigational product are allowed
             to enrol as long as they do not expect to change dose, drug or discontinue use during
             the study).

          -  Subjects who are using any medication that in the opinion of the investigator may
             affect this clinical study or evaluation of the study.

          -  Subjects who plan to use medications that are reported to exacerbate acne (such as
             vitamin D and vitamin B12, corticosteroids, androgens, haloperidol, halogens, lithium,
             hydantoin and Phenobarbital).

          -  Subjects who have a known hypersensitivity or have had previous allergic reaction to
             any of the components of the investigational product.

          -  Subjects who have used investigate therapy within the previous 12 weeks or plan to
             participate in another clinical study at the same time.

          -  Subjects who participated in another Japanese clinical study planned by
             GlaxoSmithKline K.K. in the development of investigational products for acne vulgaris.

          -  Subjects with a history of substance abuse (alcohol or drugs) or substance dependence
             within 12 months prior to screening.

          -  Subjects who have medical history suggestive of an immunocompromized status.

          -  Subjects who are employees of a GlaxoSmithKline, an investigator or clinical research
             organization involved in the study or any immediate family member of an employee
             involved in the study.

          -  Subjects who have any other condition that would put the subject at unacceptable risk
             for participation in the study.