Back to resultsStudy STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
GSK2585823(CLDM 1%-BPO 3% gel)
CLDM 1% gel twice daily
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring twice daily, once daily, CLDM 1%-BPO 3% gel, Clindamycin (CLDM), benzoyl peroxide (BPO), inflammatory lesion, non-inflammatory lesion, acne vulgaris
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 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
GSK2585823(CLDM 1%-BPO 3% gel) once daily
GSK2585823(CLDM 1%-BPO 3% gel) twice daily
CLDM 1% gel twice daily
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Absolute Change From Baseline to Week 12 in Total Lesion Counts.
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from post-randomization value at Week 12.
Secondary Outcome Measures
Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.
Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.
Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.( Weeks 1, 2, 4, 8 and 12)
Percentage of Participants With a Minimum 2-grade Improvement From Baseline to Week 12 in Investigator's Static Global Assessment (ISGA) Score
Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5(very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face.
Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12
Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5 (very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face.
Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions
The percentage of participants who had reduction in total lesions (inflammatory and non-inflammatory) of at least 50 percent from Baseline at Weeks 1, 2, 4, 8, and 12 was measured.
Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX)
MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism). MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism) for the susceptibility of clinical isolates (Propionibacterium acnes before and after application of the CLDM and NDFX was reported. MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis.
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12).
Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12
Burning/stinging, itching were evaluated independently by the participant on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01445301
Brief Title
Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects
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 -
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 27, 2011 (Actual)
Primary Completion Date
August 2, 2012 (Actual)
Study Completion Date
August 2, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
twice daily, once daily, CLDM 1%-BPO 3% gel, Clindamycin (CLDM), benzoyl peroxide (BPO), inflammatory lesion, non-inflammatory lesion, acne vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSK2585823(CLDM 1%-BPO 3% gel) once daily
Arm Type
Experimental
Arm Description
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.
Arm Title
GSK2585823(CLDM 1%-BPO 3% gel) twice daily
Arm Type
Experimental
Arm Description
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.
Arm Title
CLDM 1% gel twice daily
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GSK2585823(CLDM 1%-BPO 3% gel)
Other Intervention Name(s)
GSK2585823
Intervention Description
Topical gel in 1 g containing clindamycin 10 mg and benzoyl peroxide 30 mg
Intervention Type
Drug
Intervention Name(s)
CLDM 1% gel twice daily
Other Intervention Name(s)
CLDM
Intervention Description
Topical gel containing clindamycin 10 mg/1 g gel
Primary Outcome Measure Information:
Title
Absolute Change From Baseline to Week 12 in Total Lesion Counts.
Description
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from post-randomization value at Week 12.
Time Frame
Baseline (Day 1) and Week 12
Secondary Outcome Measure Information:
Title
Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts
Description
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.
Time Frame
Baseline (Day 1) and Weeks 1, 2, 4, and 8
Title
Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts
Description
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.
Time Frame
Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12
Title
Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
Description
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.( Weeks 1, 2, 4, 8 and 12)
Time Frame
Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12
Title
Percentage of Participants With a Minimum 2-grade Improvement From Baseline to Week 12 in Investigator's Static Global Assessment (ISGA) Score
Description
Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5(very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face.
Time Frame
Baseline (Day 1) and Week 12
Title
Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12
Description
Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5 (very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face.
Time Frame
Week 1, 2, 4, 8, and 12
Title
Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions
Description
The percentage of participants who had reduction in total lesions (inflammatory and non-inflammatory) of at least 50 percent from Baseline at Weeks 1, 2, 4, 8, and 12 was measured.
Time Frame
Baseline (Day 1) and Week 1, 2, 4, 8, and 12
Title
Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX)
Description
MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism). MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism) for the susceptibility of clinical isolates (Propionibacterium acnes before and after application of the CLDM and NDFX was reported. MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis.
Time Frame
Baseline (Day 1) and Week12
Title
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Description
Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12).
Time Frame
Baseline (Day 1) and Week 1, 2, 4, 8, and 12
Title
Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12
Description
Burning/stinging, itching were evaluated independently by the participant on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12).
Time Frame
Baseline (Day 1) and Week 1, 2, 4, 8 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Chiba
ZIP/Postal Code
273-0046
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
002-8022
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
003-0833
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
004-0074
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
004-0876
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
006-0022
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
060-0063
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
062-0042
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
064-0915
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
066-0021
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
066-0064
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
069-0813
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
090-0832
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
093-0016
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
211-0063
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
221-0825
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
532-0026
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
559-0017
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
572-0838
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
350-1305
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
111-0053
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
141-0031
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
150-0021
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
169-0075
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
194-0013
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects
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