Study STF115288, a Clinical Confirmation Study of GI148512 in the Treatment of Acne Vulgaris in Japanese Subjects

Study STF115288, a Clinical Confirmation Study of GI148512 (Benzoyl Peroxide 3% Gel) in the Treatment of Acne Vulgaris in Japanese Subjects.- A Multicenter, Randomized, Double-blinded, Vehicle-controlled, Parallel-group Study -

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.

Main inclusion criteria will be 12 to 45 years of age, who have an Investigator Static Global Assessment (ISGA) score of 2 or greater at baseline visit, and have both 17 to 60 facial inflammatory lesions (papules plus pustules) and 20 to 150 facial non-inflammatory lesions (open and closed comedones), including nasal lesions. The primary objective is to demonstrate the superiority of GI148512 to vehicle gel in total lesion counts. The secondary objectives are to demonstrate the superiority of GI148512 to vehicle gel in inflammatory lesion counts, and to evaluate the efficacy of GI148512 compared with vehicle gel at each visit. A total of 360 subjects will be enrolled and randomly assigned to one of the groups.

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.