Study STF115288, a Clinical Confirmation Study of GI148512 in the Treatment of Acne Vulgaris in Japanese Subjects
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: GI148512; vehicle gel
Intervention description: GI148512, Topical gel in 1 g containing benzoyl peroxide 30 mg; Matching vehicle gel of GI148512, not containing active ingredient (benzoyl peroxide)
Intervention MeSH terms: Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 360.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: inflammatory lesion; Benzoyl peroxide (BPO); once daily; acne vulgaris; vehicle gel; clindamycin (CLDM) 1%-BPO 3% gel; non-inflammatory lesion

Summary:

      This is a multicenter, randomized, double-blinded, vehicle-controlled, parallel-group study
      in Japanese subjects with acne vulgaris to demonstrate the efficacy of GI148512 (benzoyl
      peroxide [BPO] 3% gel) when applied once daily for 12 weeks. This study will also evaluate
      the safety of GI148512 when applied topically once daily for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects 12 to 45 years (inclusive) of age in good general health.

          -  Subjects must have both on the face:

        A) A minimum of 17 but not more than 60 inflammatory lesions (papules / pustules),
        including nasal lesions.

        And B) A minimum of 20 but not more than 150 non-inflammatory lesions (open / closed
        comedones), including nasal lesions.

          -  An ISGA (global assessment of severity by the investigator: refer to Section 6.2.1
             "Assessment") score of 2 or greater at baseline.

          -  Females of childbearing potential and women who are less than 2 years from their last
             menses must agree to use the contraception.

          -  The ability and willingness to follow all study procedures and attend all scheduled
             visits.

          -  The ability to understand and sign a written informed consent form (Written informed
             consent must be obtained also from the parent or guardian in case of subject under 20
             years of age at the time of given consent).

        Exclusion Criteria:

          -  Have any nodule-cystic lesions at baseline.

          -  Are pregnant or breast-feeding.

          -  Used any of the following agents on the face within the previous 2 weeks: Topical
             antibiotics (or systemic antibiotics); Topical anti-acne medications (e.g., BPO,
             azelaic acid, resorcinol, salicylates); Abradants, facials, or peels containing
             glycolic or other acids; Masks, washes or soaps containing BPO, sulfacetamide sodium,
             or salicylic acid; Non-mild facial cleansers (e.g., facial scrub, cleansers containing
             agents with anti-inflammatory action); Moisturizers that contain retinol, salicylic
             acid, or α- or β-hydroxy acids; Astringents and toner (Subjects are allowed to enroll
             in this study, if the subject has been on treatment for more than 2 consecutive weeks
             prior to start of investigational product use).

          -  Used the following agents on the face or performed the following procedure within the
             previous 4 weeks: Topical corticosteroids (Use of inhaled, intra-articular, or
             intra-lesional steroids other than for facial acne is acceptable); Facial procedure
             (such as chemical or laser peel, microdermabrasion, blue light treatment, etc.).

          -  Used systemic retinoids within the previous 6 months or topical retinoids on the face
             within the previous 6 weeks.

          -  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).

          -  Used any medication that in the opinion of the investigator may affect this clinical
             study or evaluation of the study.

          -  Plan to use medications that are reported to exacerbate acne (e.g., mega-doses of
             certain vitamins, such as vitamin D [>2000 IU/day] and vitamin B12 [>1 mg/day],
             corticosteroids*, androgens, haloperidol, halogens [e.g., iodide and bromide],
             lithium, hydantoin, and phenobarbital).

             *: except the using of topical corticosteroids (e.g., inhaled, intra-articular, or
             intralesional steroids) other than for facial acne.

          -  Have a known hypersensitivity or have had previous allergic reaction to any of the
             components of the investigational product.

          -  Used any investigational therapy within the previous 12 weeks, or plan to participate
             in another clinical study at the same time.

          -  Participated in Japanese clinical studies planned by GlaxoSmithKline K.K. in the
             development of investigational products for acne vulgaris.

          -  Are currently abusing drugs or alcohol.

          -  Have a significant medical history of being immunocompromised.

          -  People as follows and the family members; Employees of GlaxoSmithKline, contract
             research organization (CRO) or site management organization (SMO); Investigators.

          -  Have other conditions that would put the subject at unacceptable risk for
             participation in the study.