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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01400932
Recruitment Status : Completed
First Posted : July 25, 2011
Results First Posted : August 5, 2014
Last Update Posted : August 5, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: GI148512
Drug: vehicle gel
Enrollment 360
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GI148512 Vehicle Gel
Hide Arm/Group Description Participants applied 2 finger tip units (FTU) of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks. Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Period Title: Overall Study
Started 178 182
Completed 164 167
Not Completed 14 15
Reason Not Completed
Adverse Event             10             5
Lack of Efficacy             0             3
Withdrawal by Subject             2             6
Lost to Follow-up             1             0
Protocol Deviation             0             1
Met Protocol-defined Stopping Criteria             1             0
Arm/Group Title GI148512 Vehicle Gel Total
Hide Arm/Group Description Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks. Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 178 182 360
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 178 participants 182 participants 360 participants
21.3  (5.93) 22.4  (6.76) 21.9  (6.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants 182 participants 360 participants
Female
118
  66.3%
116
  63.7%
234
  65.0%
Male
60
  33.7%
66
  36.3%
126
  35.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian-Japanese Heritage Number Analyzed 178 participants 182 participants 360 participants
178 182 360
Total Lesion Counts at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Lesion counts
Number Analyzed 178 participants 182 participants 360 participants
72.1  (33.40) 70.3  (30.89) 71.2  (32.12)
[1]
Measure Description: The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face at each study visit.
Non-inflammatory Lesion (NIL) Counts at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Lesion counts
Number Analyzed 178 participants 182 participants 360 participants
44.2  (28.03) 42.7  (26.28) 43.4  (27.14)
[1]
Measure Description: The investigator/subinvestigator counted all non-inflammatory lesions (open and closed comedo) on the face at each study visit. An open comedo is 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 comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color.
Inflammatory Lesion (IL) Counts at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Lesion counts
Number Analyzed 178 participants 182 participants 360 participants
28.0  (10.76) 27.5  (10.09) 27.7  (10.41)
[1]
Measure Description: The investigator/subinvestigator counted all inflammatory lesions (papules, pustules, and nodular lesions [NL]) on the face at each study visit. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter.
Participants with the Indicated Investigational's Static Global Assessment (ISGA) Score at Baseline   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 178 participants 182 participants 360 participants
0: Clear 0 0 0
1: Almost Clear 0 0 0
2: Mild Severity 41 45 86
3: Moderate Severity 117 118 235
4: Severe 20 19 39
5: Very Severe 0 0 0
[1]
Measure Description: Investigators evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NILs with no more than rare papules; 2=mild acne: greater than Grade 1, some NILs with no more than a few ILs (papules/pustules only, no NLs); 3=moderate acne: greater than Grade 2, up to many NILs and had some ILs, but no more than one small NL; 4=severe acne: greater than Grade 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe acne: many NILs and ILs and more than a few NLs, had cystic lesions.
1.Primary Outcome
Title Absolute Change in Total Lesion Counts From Baseline to Week 12
Hide Description The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face at each study visit. An open comedo is 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 comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants who received at least one application of investigational product. Only those participants with data available at the specified time point were analyzed. Analysis was based on an analysis of covariance (ANCOVA) model with terms for Baseline value, treatment, and center.
Arm/Group Title GI148512 Vehicle Gel
Hide Arm/Group Description:
Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Overall Number of Participants Analyzed 177 182
Least Squares Mean (Standard Error)
Unit of Measure: Lesion counts
-42.9  (1.93) -22.0  (1.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -21.0
Confidence Interval (2-Sided) 95%
-26.2 to -15.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Absolute Change in Total Lesion Counts From Baseline to Weeks 1, 2, 4, and 8
Hide Description The investigator/subinvestigator counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedo) on the face at each study visit. An open comedo is 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 comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter.Data were analyzed using an ANCOVA model with terms for Baseline value, treatment, and center.
Time Frame Baseline; Weeks 1, 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title GI148512 Vehicle Gel
Hide Arm/Group Description:
Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Overall Number of Participants Analyzed 178 182
Least Squares Mean (Standard Error)
Unit of Measure: Lesion counts
Week 1, n=175, 179 -15.9  (1.38) -8.3  (1.35)
Week 2, n=177, 182 -24.4  (1.60) -13.3  (1.57)
Week 4, n=177, 182 -32.0  (1.68) -16.8  (1.65)
Week 8, n=177, 182 -39.6  (1.79) -20.1  (1.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 1
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 2
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 4
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 8
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12
Hide Description The investigator/subinvestigator counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedo) on the face at each study visit. An open comedo is 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 comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Data were analyzed using an ANCOVA model with terms for Baseline value, treatment, and center.
Time Frame Baseline; Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title GI148512 Vehicle Gel
Hide Arm/Group Description:
Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Overall Number of Participants Analyzed 178 182
Least Squares Mean (Standard Error)
Unit of Measure: Lesion counts
IL, Week 1, n=175, 179 -8.2  (0.68) -4.6  (0.67)
IL, Week 2, n=177, 182 -12.3  (0.81) -5.8  (0.79)
IL, Week 4, n=177, 182 -14.9  (0.83) -8.4  (0.82)
IL, Week 8, n=177, 182 -16.8  (0.90) -7.8  (0.88)
IL, Week 12, n=177, 182 -18.3  (0.90) -9.6  (0.88)
NIL, Week 1, n=175, 179 -7.7  (1.08) -3.7  (1.06)
NIL, Week 2, n=177, 182 -12.2  (1.27) -7.5  (1.25)
NIL, Week 4, n=177, 182 -17.1  (1.32) -8.4  (1.30)
NIL, Week 8, n=177, 182 -22.8  (1.38) -12.3  (1.35)
NIL, Week 12, n=177, 182 -24.6  (1.54) -12.3  (1.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 1; IL
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 2; IL
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 4; IL
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 8; IL
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 12; IL
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments Week 1; NIL
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments Week 2; NIL
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 4; NIL
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 8; NIL
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 12; NIL
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12
Hide Description The percent change from Baseline to Weeks 1, 2, 4, 8, and 12 in lesion counts (total [inflammatory and non-inflammatory], inflammatory [IL], and non-inflammatory [NIL]) was analyzed using an ANOVA model with terms for treatment and center. Percent change from Baseline was calculated as: (post-Baseline value minus Baseline value) * 100.
Time Frame Baseline; Weeks 1, 2, 4 and 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title GI148512 Vehicle Gel
Hide Arm/Group Description:
Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Overall Number of Participants Analyzed 178 182
Least Squares Mean (Standard Error)
Unit of Measure: Percent change in lesion counts
Total, Week 1, n=175, 179 -22.26  (1.705) -12.07  (1.676)
Total, Week 2, n=177, 182 -36.17  (2.052) -19.63  (2.014)
Total, Week 4, n=177, 182 -45.43  (2.177) -24.50  (2.137)
Total, Week 8, n=177, 182 -55.40  (2.378) -27.43  (2.334)
Total, Week 12, n=177,182 -59.79  (2.754) -30.15  (2.704)
IL, Week 1, n=175, 179 -30.85  (2.379) -16.78  (2.338)
IL, Week 2, n=177, 182 -46.40  (2.720) -20.74  (2.670)
IL, Week 4, n=177, 182 -54.38  (2.696) -30.54  (2.647)
IL, Week 8, n=177, 182 -60.33  (2.810) -28.02  (2.759)
IL, Week 12, n=177,182 -64.68  (2.859) -36.16  (2.807)
NIL, Week 1, n=175, 179 -16.99  (2.127) -7.92  (2.091)
NIL, Week 2, n=177, 182 -29.78  (2.570) -17.93  (2.523)
NIL, Week 4, n=177, 182 -39.88  (2.584) -19.72  (2.536)
NIL, Week 8, n=177, 182 -51.64  (2.923) -25.86  (2.869)
NIL, Week 12, n=177,182 -55.17  (3.533) -26.36  (3.468)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 1; Total
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 2; Total
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 4; Total
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 8; Total
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 12; Total
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 1; IL
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 2; IL
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 4; IL
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 8; IL
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 12; IL
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Week 1; NIL
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 2; NIL
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 4; NIL
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 8; NIL
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 12; NIL
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants Who Had a Minimum 2-grade Improvement in the Investigator’s Static Global Assessment (ISGA) Score From Baseline to Week 12
Hide Description Investigators evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no inflammatory lesions (ILs) or non-inflammatory lesions (NILs); 1=almost clear: rare NILs with no more than rare papules; 2=mild acne: greater than Grade 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate acne: greater than Grade 2, up to many NILs and had some ILs, but no more than one small NL; 4=severe acne: greater than Grade 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe acne: many NILs and ILs and more than a few NLs, had cystic lesions.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at the specified time point were analyzed.
Arm/Group Title GI148512 Vehicle Gel
Hide Arm/Group Description:
Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Overall Number of Participants Analyzed 164 166
Measure Type: Number
Unit of Measure: Participants
31 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants Who Had an ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8, and 12
Hide Description Investigators evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no inflammatory lesions (ILs) or non-inflammatory lesions (NILs); 1=almost clear: rare NILs with no more than rare papules; 2=mild acne: greater than Grade 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate acne: greater than Grade 2, up to many NILs and had some ILs, but no more than one small NL; 4=severe acne: greater than Grade 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe acne: many NILs and ILs and more than a few NLs, had cystic lesions.
Time Frame Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title GI148512 Vehicle Gel
Hide Arm/Group Description:
Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Overall Number of Participants Analyzed 178 182
Measure Type: Number
Unit of Measure: Participants
Week 1, n=175, 179 4 1
Week 2, n=177, 179 6 0
Week 4, n=176, 178 12 1
Week 8, n= 168, 173 16 3
Week 12, n=164, 166 35 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.174
Comments Week 1
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments Week 2
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Week 4
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Week 8
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 12
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants Who Had a Reduction in Total Lesions of at Least 50% From Baseline to Weeks 1, 2, 4, 8, and 12
Hide Description The proportion of participants who have a reduction in total lesions (inflammatory and non-inflammatory) of at least 50% from Baseline at Weeks 1, 2, 4, 8, and 12 was measured.
Time Frame Baseline; Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title GI148512 Vehicle Gel
Hide Arm/Group Description:
Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Overall Number of Participants Analyzed 178 182
Measure Type: Number
Unit of Measure: Participants
Week 1, n=175, 179 25 7
Week 2, n=177, 182 60 32
Week 4, n=177, 182 86 38
Week 8, n= 177, 182 115 54
Week 12, n=177, 182 116 73
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 1
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 2
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 4
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 8
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GI148512, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Week 12
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal
Hide Description Erythema (redness), dryness, and peeling were evaluated independently by the investigator as: 0 (absent)=no erythema, dryness, or peeling; 1 (slight)=faint red/pink coloration, barely perceptible dryness with no flakes or fissure, mild localized peeling; 2 (mild)=light red/pink coloration, perceptible dryness with no flakes/fissure, mild and diffuse peeling; 3 (moderate)=medium red coloration, easily noted dryness and flakes but no fissure, moderate and diffuse peeling; 4 (severe)=beet red coloration, dryness with flakes and fissure, prominent dense peeling. Change from Baseline was calculated as the post-Baseline/Withdrawal value minus the Baseline value.
Time Frame Baseline; Weeks 1, 2, 4, 8, 12 or Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title GI148512 Vehicle Gel
Hide Arm/Group Description:
Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Overall Number of Participants Analyzed 178 182
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Erythema, Week 1, n=177, 181 -0.03  (0.53) -0.13  (0.53)
Erythema, Week 2, n=177, 176 -0.07  (0.62) -0.19  (0.61)
Erythema, Week 4, n=173, 174 -0.13  (0.68) -0.20  (0.66)
Erythema, Week 8, n= 164, 168 -0.19  (0.61) -0.23  (0.70)
Erythema, Week 12, n=164, 167 -0.19  (0.74) -0.26  (0.70)
Erythema, Withdrawal, n=12, 15 1.17  (1.80) 0.47  (0.99)
Dryness, Week 1, n=177, 181 0.16  (0.62) -0.08  (0.36)
Dryness, Week 2, n=177, 176 0.14  (0.56) -0.06  (0.38)
Dryness, Week 4, n=173, 174 0.06  (0.52) -0.06  (0.39)
Dryness, Week 8, n=164, 168 0.00  (0.46) -0.08  (0.46)
Dryness, Week 12, n=164, 167 -0.04  (0.53) -0.11  (0.44)
Dryness, Withdrawal, n=12, 15 0.58  (1.24) 0.33  (1.11)
Peeling, Week 1, n=177, 181 0.01  (0.43) -0.03  (0.29)
Peeling, Week 2, n=177, 176 0.02  (0.50) -0.03  (0.31)
Peeling, Week 4, n=173, 174 -0.01  (0.41) 0.00  (0.32)
Peeling, Week 8, n=164, 168 -0.01  (0.48) -0.01  (0.35)
Peeling, Week 12, n=164, 167 -0.02  (0.51) -0.05  (0.27)
Peeling, Withdrawal, n=12, 15 0.42  (0.90) 0.13  (0.92)
9.Secondary Outcome
Title Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal
Hide Description Itching and burning/stinging were evaluated by the participant as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (mild)=noticeable discomfort that caused continuous awareness; 3 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 4 (severe)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the post-Baseline/Withdrawal value minus the Baseline value.
Time Frame Baseline; Weeks 1, 2, 4, 8, 12 or withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title GI148512 Vehicle Gel
Hide Arm/Group Description:
Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Overall Number of Participants Analyzed 178 182
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Itching, Week 1, n=177, 181 -0.01  (0.45) -0.12  (0.48)
Itching, Week 2, n=177, 176 0.01  (0.48) -0.13  (0.53)
Itching, Week 4, n=173, 174 0.01  (0.60) -0.14  (0.54)
Itching, Week 8, n=164, 168 -0.04  (0.51) -0.11  (0.52)
Itching, Week 12, n=164, 167 -0.07  (0.44) -0.12  (0.52)
Itching, Withdrawal, n=12, 15 1.33  (1.44) 0.20  (1.21)
Burning/Stinging, Week 1, n=177, 181 0.15  (0.49) -0.04  (0.29)
Burning/Stinging, Week 2, n=177, 176 0.15  (0.58) -0.03  (0.34)
Burning/Stinging, Week 4, n=173, 174 0.05  (0.42) -0.02  (0.40)
Burning/Stinging, Week 8, n=164, 168 0.04  (0.37) -0.02  (0.44)
Burning/Stinging, Week 12, n=164, 167 0.05  (0.49) -0.04  (0.38)
Burning/Stinging,Withdrawal, n=12, 15 1.00  (1.21) 0.73  (1.39)
Time Frame Serious adverse events (SAEs) and non-serious AEs collected from the start of study treatment until Week 12 or premature withdrawal are reported.
Adverse Event Reporting Description SAEs and non-serious AEs are reported for members of the ITT Population,comprised of all randomized participants who received at least one application of investigational product.
 
Arm/Group Title GI148512 Vehicle Gel
Hide Arm/Group Description Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks. Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
All-Cause Mortality
GI148512 Vehicle Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GI148512 Vehicle Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   0/178 (0.00%)   0/182 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GI148512 Vehicle Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   78/178 (43.82%)   61/182 (33.52%) 
General disorders     
Facial pain † 1  19/178 (10.67%)  2/182 (1.10%) 
Infections and infestations     
Nasopharyngitis † 1  40/178 (22.47%)  53/182 (29.12%) 
Skin and subcutaneous tissue disorders     
Dry skin † 1  16/178 (8.99%)  6/182 (3.30%) 
Dermatitis contact † 1  16/178 (8.99%)  2/182 (1.10%) 
Pruritus † 1  13/178 (7.30%)  4/182 (2.20%) 
Erythema † 1  10/178 (5.62%)  2/182 (1.10%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01400932     History of Changes
Other Study ID Numbers: 115288
First Submitted: July 21, 2011
First Posted: July 25, 2011
Results First Submitted: July 10, 2014
Results First Posted: August 5, 2014
Last Update Posted: August 5, 2014