Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01445301
First received: September 15, 2011
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

This is a multicenter, randomized, single-blinded (investigator's blinded), active-controlled (clindamycin [CLDM] 1% gel), parallel-group study in Japanese subjects with acne vulgaris to demonstrate the efficacy of GSK2585823 (CLDM 1%-benzoyl peroxide [BPO] 3% gel) when applied once or twice daily for 12 weeks. This study will also evaluate the safety of GSK2585823 when applied topically either once or twice daily for 12 weeks.


Condition Intervention Phase
Acne Vulgaris
Drug: GSK2585823(CLDM 1%-BPO 3% gel)
Drug: CLDM 3% gel twice daily
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Study STF115287, a Clinical Confirmation Study of GSK2585823 (Clindamycin 1%-Benzoyl Peroxide 3% Gel) in the Treatment of Acne Vulgaris in Japanese Subjects. - A Multicenter, Randomized, Single-blind, Active-controlled, Parallel-group Study -

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The absolute change in total lesion counts [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The absolute change in total lesion counts [ Time Frame: from baseline to Weeks 1, 2, 4, and 8 ] [ Designated as safety issue: No ]
  • The absolute change in lesion counts (inflammatory and non-inflammatory) [ Time Frame: from baseline to Weeks 1, 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
  • The percent (%) change in lesion counts (total, inflammatory, and non-inflammatory) [ Time Frame: from baseline to Weeks 1, 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
  • The proportion of subjects who have a minimum 2-grade improvement in Investigator's Static Global Assessment (ISGA) score [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
  • The proportion of subjects who have an ISGA score of 0 or 1 [ Time Frame: Weeks 1, 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
  • The proportion of subjects who have a reduction in total lesions of at least 50% [ Time Frame: from baseline to Weeks 1, 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Minimum Inhibitory Concentration (MIC) of clinical isolates to antibiotics (CLDM and NDFX) [ Time Frame: Baseline and Week12 ] [ Designated as safety issue: No ]
  • Local tolerability (erythema, dryness, peeling, itching, and burning/stinging) [ Time Frame: Weeks 1, 2, 4, 8, and 12 ] [ Designated as safety issue: No ]

Enrollment: 800
Study Start Date: September 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK2585823(CLDM 1%-BPO 3% gel) once daily
Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be once daily in the evening/bedtime.
Drug: GSK2585823(CLDM 1%-BPO 3% gel)
Topical gel in 1 g containing clindamycin 10 mg and benzoyl peroxide 30 mg
Other Name: GSK2585823
Experimental: GSK2585823(CLDM 1%-BPO 3% gel) twice daily
Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be twice daily in the morning and evening/bedtime.
Drug: GSK2585823(CLDM 1%-BPO 3% gel)
Topical gel in 1 g containing clindamycin 10 mg and benzoyl peroxide 30 mg
Other Name: GSK2585823
Active Comparator: CLDM 3% gel twice daily
Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be twice daily in the morning and evening/bedtime.
Drug: CLDM 3% gel twice daily
Topical gel containing clindamycin 10 mg/1 g gel
Other Name: CLDM

Detailed Description:

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 objectives are to demonstrate the superiority of GSK2585823 twice daily to CLDM twice daily in total lesion counts, and to demonstrate the non-inferiority of GSK2585823 once daily to CLDM twice daily in total lesion counts. The secondary objectives are to demonstrate the non-inferiority of GSK2585823 once daily to CLDM twice daily in inflammatory lesion counts, and to evaluate the efficacy of GSK2585823 once or twice daily compared with CLDM twice daily at each visit. A total of 800 subjects will be enrolled and randomly assigned to one of the groups.

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  • Have a history or presence of regional enteritis, inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea or antibiotic-associated colitis) or similar symptoms.
  • 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 intra-lesional 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445301

Locations
Japan
GSK Investigational Site
Chiba, Japan, 273-0046
GSK Investigational Site
Hokkaido, Japan, 004-0876
GSK Investigational Site
Hokkaido, Japan, 069-0813
GSK Investigational Site
Hokkaido, Japan, 062-0042
GSK Investigational Site
Hokkaido, Japan, 004-0074
GSK Investigational Site
Hokkaido, Japan, 002-8022
GSK Investigational Site
Hokkaido, Japan, 093-0016
GSK Investigational Site
Hokkaido, Japan, 066-0021
GSK Investigational Site
Hokkaido, Japan, 066-0064
GSK Investigational Site
Hokkaido, Japan, 006-0022
GSK Investigational Site
Hokkaido, Japan, 090-0832
GSK Investigational Site
Hokkaido, Japan, 064-0915
GSK Investigational Site
Hokkaido, Japan, 003-0833
GSK Investigational Site
Hokkaido, Japan, 060-0063
GSK Investigational Site
Kanagawa, Japan, 221-0825
GSK Investigational Site
Kanagawa, Japan, 211-0063
GSK Investigational Site
Osaka, Japan, 532-0026
GSK Investigational Site
Osaka, Japan, 593-8324
GSK Investigational Site
Osaka, Japan, 572-0838
GSK Investigational Site
Osaka, Japan, 559-0017
GSK Investigational Site
Saitama, Japan, 350-1305
GSK Investigational Site
Tokyo, Japan, 111-0053
GSK Investigational Site
Tokyo, Japan, 150-0021
GSK Investigational Site
Tokyo, Japan, 141-0031
GSK Investigational Site
Tokyo, Japan, 194-0013
GSK Investigational Site
Tokyo, Japan, 169-0075
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01445301     History of Changes
Other Study ID Numbers: 115287
Study First Received: September 15, 2011
Last Updated: August 16, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by GlaxoSmithKline:
twice daily
once daily
CLDM 1%-BPO 3% gel
Clindamycin (CLDM)
benzoyl peroxide (BPO)
inflammatory lesion
non-inflammatory lesion
acne vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014