Trial Outcomes & Findings for Study STF115288, a Clinical Confirmation Study of GI148512 in the Treatment of Acne Vulgaris in Japanese Subjects (NCT NCT01400932)

Last Updated: 2014-08-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

360 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2014-08-05

Participant Flow

Participant milestones

Participant milestones
Measure	GI148512 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.	Vehicle Gel 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 Study STARTED	178	182
Overall Study COMPLETED	164	167
Overall Study NOT COMPLETED	14	15

Reasons for withdrawal

Reasons for withdrawal
Measure	GI148512 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.	Vehicle Gel 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 Study Adverse Event	10	5
Overall Study Lack of Efficacy	0	3
Overall Study Withdrawal by Subject	2	6
Overall Study Lost to Follow-up	1	0
Overall Study Protocol Deviation	0	1
Overall Study Met Protocol-defined Stopping Criteria	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GI148512 n=178 Participants 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.	Vehicle Gel n=182 Participants 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 n=360 Participants Total of all reporting groups
Age, Continuous	21.3 Years STANDARD_DEVIATION 5.93 • n=93 Participants	22.4 Years STANDARD_DEVIATION 6.76 • n=4 Participants	21.9 Years STANDARD_DEVIATION 6.38 • n=27 Participants
Sex: Female, Male Female	118 Participants n=93 Participants	116 Participants n=4 Participants	234 Participants n=27 Participants
Sex: Female, Male Male	60 Participants n=93 Participants	66 Participants n=4 Participants	126 Participants n=27 Participants
Race/Ethnicity, Customized Asian-Japanese Heritage	178 Participants n=93 Participants	182 Participants n=4 Participants	360 Participants n=27 Participants
Total Lesion Counts at Baseline	72.1 lesion counts STANDARD_DEVIATION 33.40 • n=93 Participants	70.3 lesion counts STANDARD_DEVIATION 30.89 • n=4 Participants	71.2 lesion counts STANDARD_DEVIATION 32.12 • n=27 Participants
Non-inflammatory Lesion (NIL) Counts at Baseline	44.2 lesion counts STANDARD_DEVIATION 28.03 • n=93 Participants	42.7 lesion counts STANDARD_DEVIATION 26.28 • n=4 Participants	43.4 lesion counts STANDARD_DEVIATION 27.14 • n=27 Participants
Inflammatory Lesion (IL) Counts at Baseline	28.0 lesion counts STANDARD_DEVIATION 10.76 • n=93 Participants	27.5 lesion counts STANDARD_DEVIATION 10.09 • n=4 Participants	27.7 lesion counts STANDARD_DEVIATION 10.41 • n=27 Participants
Participants with the Indicated Investigational's Static Global Assessment (ISGA) Score at Baseline 0: Clear	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Participants with the Indicated Investigational's Static Global Assessment (ISGA) Score at Baseline 1: Almost Clear	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Participants with the Indicated Investigational's Static Global Assessment (ISGA) Score at Baseline 2: Mild Severity	41 participants n=93 Participants	45 participants n=4 Participants	86 participants n=27 Participants
Participants with the Indicated Investigational's Static Global Assessment (ISGA) Score at Baseline 3: Moderate Severity	117 participants n=93 Participants	118 participants n=4 Participants	235 participants n=27 Participants
Participants with the Indicated Investigational's Static Global Assessment (ISGA) Score at Baseline 4: Severe	20 participants n=93 Participants	19 participants n=4 Participants	39 participants n=27 Participants
Participants with the Indicated Investigational's Static Global Assessment (ISGA) Score at Baseline 5: Very Severe	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: 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.

Outcome measures

Outcome measures
Measure	GI148512 n=177 Participants 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.	Vehicle Gel n=182 Participants 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.
Absolute Change in Total Lesion Counts From Baseline to Week 12	-42.9 Lesion counts Standard Error 1.93	-22.0 Lesion counts Standard Error 1.89

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, and 8

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GI148512 n=178 Participants 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.	Vehicle Gel n=182 Participants 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.
Absolute Change in Total Lesion Counts From Baseline to Weeks 1, 2, 4, and 8 Week 4, n=177, 182	-32.0 Lesion counts Standard Error 1.68	-16.8 Lesion counts Standard Error 1.65
Absolute Change in Total Lesion Counts From Baseline to Weeks 1, 2, 4, and 8 Week 1, n=175, 179	-15.9 Lesion counts Standard Error 1.38	-8.3 Lesion counts Standard Error 1.35
Absolute Change in Total Lesion Counts From Baseline to Weeks 1, 2, 4, and 8 Week 2, n=177, 182	-24.4 Lesion counts Standard Error 1.60	-13.3 Lesion counts Standard Error 1.57
Absolute Change in Total Lesion Counts From Baseline to Weeks 1, 2, 4, and 8 Week 8, n=177, 182	-39.6 Lesion counts Standard Error 1.79	-20.1 Lesion counts Standard Error 1.75

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12

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.

Outcome measures

Outcome measures
Measure	GI148512 n=178 Participants 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.	Vehicle Gel n=182 Participants 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.
Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12 IL, Week 4, n=177, 182	-14.9 Lesion counts Standard Error 0.83	-8.4 Lesion counts Standard Error 0.82
Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12 IL, Week 8, n=177, 182	-16.8 Lesion counts Standard Error 0.90	-7.8 Lesion counts Standard Error 0.88
Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12 IL, Week 12, n=177, 182	-18.3 Lesion counts Standard Error 0.90	-9.6 Lesion counts Standard Error 0.88
Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12 NIL, Week 2, n=177, 182	-12.2 Lesion counts Standard Error 1.27	-7.5 Lesion counts Standard Error 1.25
Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12 IL, Week 1, n=175, 179	-8.2 Lesion counts Standard Error 0.68	-4.6 Lesion counts Standard Error 0.67
Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12 IL, Week 2, n=177, 182	-12.3 Lesion counts Standard Error 0.81	-5.8 Lesion counts Standard Error 0.79
Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12 NIL, Week 1, n=175, 179	-7.7 Lesion counts Standard Error 1.08	-3.7 Lesion counts Standard Error 1.06
Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12 NIL, Week 4, n=177, 182	-17.1 Lesion counts Standard Error 1.32	-8.4 Lesion counts Standard Error 1.30
Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12 NIL, Week 8, n=177, 182	-22.8 Lesion counts Standard Error 1.38	-12.3 Lesion counts Standard Error 1.35
Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12 NIL, Week 12, n=177, 182	-24.6 Lesion counts Standard Error 1.54	-12.3 Lesion counts Standard Error 1.51

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4 and 8 and 12

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.

Outcome measures

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: ITT Population. Only those participants with data available at the specified time point were analyzed.

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.

Outcome measures

Outcome measures
Measure	GI148512 n=164 Participants 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.	Vehicle Gel n=166 Participants 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.
Number of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12	31 Participants	2 Participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, and 12

Outcome measures

Outcome measures
Measure	GI148512 n=178 Participants 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.	Vehicle Gel n=182 Participants 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.
Number of Participants Who Had an ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8, and 12 Week 1, n=175, 179	4 Participants	1 Participants
Number of Participants Who Had an ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8, and 12 Week 2, n=177, 179	6 Participants	0 Participants
Number of Participants Who Had an ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8, and 12 Week 4, n=176, 178	12 Participants	1 Participants
Number of Participants Who Had an ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8, and 12 Week 8, n= 168, 173	16 Participants	3 Participants
Number of Participants Who Had an ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8, and 12 Week 12, n=164, 166	35 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12

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.

Outcome measures

Outcome measures
Measure	GI148512 n=178 Participants 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.	Vehicle Gel n=182 Participants 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.
Number of Participants Who Had a Reduction in Total Lesions of at Least 50% From Baseline to Weeks 1, 2, 4, 8, and 12 Week 12, n=177, 182	116 Participants	73 Participants
Number of Participants Who Had a Reduction in Total Lesions of at Least 50% From Baseline to Weeks 1, 2, 4, 8, and 12 Week 1, n=175, 179	25 Participants	7 Participants
Number of Participants Who Had a Reduction in Total Lesions of at Least 50% From Baseline to Weeks 1, 2, 4, 8, and 12 Week 2, n=177, 182	60 Participants	32 Participants
Number of Participants Who Had a Reduction in Total Lesions of at Least 50% From Baseline to Weeks 1, 2, 4, 8, and 12 Week 4, n=177, 182	86 Participants	38 Participants
Number of Participants Who Had a Reduction in Total Lesions of at Least 50% From Baseline to Weeks 1, 2, 4, 8, and 12 Week 8, n= 177, 182	115 Participants	54 Participants

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, 8, 12 or Withdrawal

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GI148512 n=178 Participants 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.	Vehicle Gel n=182 Participants 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.
Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Erythema, Week 4, n=173, 174	-0.13 Scores on a scale Standard Deviation 0.68	-0.20 Scores on a scale Standard Deviation 0.66
Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Erythema, Week 12, n=164, 167	-0.19 Scores on a scale Standard Deviation 0.74	-0.26 Scores on a scale Standard Deviation 0.70
Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Erythema, Withdrawal, n=12, 15	1.17 Scores on a scale Standard Deviation 1.80	0.47 Scores on a scale Standard Deviation 0.99
Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Peeling, Week 2, n=177, 176	0.02 Scores on a scale Standard Deviation 0.50	-0.03 Scores on a scale Standard Deviation 0.31
Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Peeling, Week 4, n=173, 174	-0.01 Scores on a scale Standard Deviation 0.41	0.00 Scores on a scale Standard Deviation 0.32
Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Dryness, Week 1, n=177, 181	0.16 Scores on a scale Standard Deviation 0.62	-0.08 Scores on a scale Standard Deviation 0.36
Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Dryness, Week 2, n=177, 176	0.14 Scores on a scale Standard Deviation 0.56	-0.06 Scores on a scale Standard Deviation 0.38
Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Dryness, Week 4, n=173, 174	0.06 Scores on a scale Standard Deviation 0.52	-0.06 Scores on a scale Standard Deviation 0.39
Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Dryness, Week 8, n=164, 168	0.00 Scores on a scale Standard Deviation 0.46	-0.08 Scores on a scale Standard Deviation 0.46
Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Dryness, Week 12, n=164, 167	-0.04 Scores on a scale Standard Deviation 0.53	-0.11 Scores on a scale Standard Deviation 0.44
Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Dryness, Withdrawal, n=12, 15	0.58 Scores on a scale Standard Deviation 1.24	0.33 Scores on a scale Standard Deviation 1.11
Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Peeling, Week 1, n=177, 181	0.01 Scores on a scale Standard Deviation 0.43	-0.03 Scores on a scale Standard Deviation 0.29
Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Peeling, Week 8, n=164, 168	-0.01 Scores on a scale Standard Deviation 0.48	-0.01 Scores on a scale Standard Deviation 0.35
Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Peeling, Week 12, n=164, 167	-0.02 Scores on a scale Standard Deviation 0.51	-0.05 Scores on a scale Standard Deviation 0.27
Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Peeling, Withdrawal, n=12, 15	0.42 Scores on a scale Standard Deviation 0.90	0.13 Scores on a scale Standard Deviation 0.92
Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Erythema, Week 1, n=177, 181	-0.03 Scores on a scale Standard Deviation 0.53	-0.13 Scores on a scale Standard Deviation 0.53
Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Erythema, Week 2, n=177, 176	-0.07 Scores on a scale Standard Deviation 0.62	-0.19 Scores on a scale Standard Deviation 0.61
Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Erythema, Week 8, n= 164, 168	-0.19 Scores on a scale Standard Deviation 0.61	-0.23 Scores on a scale Standard Deviation 0.70

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 2, 4, 8, 12 or withdrawal

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GI148512 n=178 Participants 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.	Vehicle Gel n=182 Participants 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.
Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Itching, Week 4, n=173, 174	0.01 Scores on a scale Standard Deviation 0.60	-0.14 Scores on a scale Standard Deviation 0.54
Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Itching, Week 8, n=164, 168	-0.04 Scores on a scale Standard Deviation 0.51	-0.11 Scores on a scale Standard Deviation 0.52
Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Itching, Week 1, n=177, 181	-0.01 Scores on a scale Standard Deviation 0.45	-0.12 Scores on a scale Standard Deviation 0.48
Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Burning/Stinging, Week 2, n=177, 176	0.15 Scores on a scale Standard Deviation 0.58	-0.03 Scores on a scale Standard Deviation 0.34
Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Itching, Week 2, n=177, 176	0.01 Scores on a scale Standard Deviation 0.48	-0.13 Scores on a scale Standard Deviation 0.53
Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Itching, Week 12, n=164, 167	-0.07 Scores on a scale Standard Deviation 0.44	-0.12 Scores on a scale Standard Deviation 0.52
Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Itching, Withdrawal, n=12, 15	1.33 Scores on a scale Standard Deviation 1.44	0.20 Scores on a scale Standard Deviation 1.21
Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Burning/Stinging, Week 1, n=177, 181	0.15 Scores on a scale Standard Deviation 0.49	-0.04 Scores on a scale Standard Deviation 0.29
Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Burning/Stinging, Week 4, n=173, 174	0.05 Scores on a scale Standard Deviation 0.42	-0.02 Scores on a scale Standard Deviation 0.40
Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Burning/Stinging, Week 8, n=164, 168	0.04 Scores on a scale Standard Deviation 0.37	-0.02 Scores on a scale Standard Deviation 0.44
Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Burning/Stinging, Week 12, n=164, 167	0.05 Scores on a scale Standard Deviation 0.49	-0.04 Scores on a scale Standard Deviation 0.38
Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal Burning/Stinging,Withdrawal, n=12, 15	1.00 Scores on a scale Standard Deviation 1.21	0.73 Scores on a scale Standard Deviation 1.39

Adverse Events

GI148512

Serious events: 0 serious events

Other events: 78 other events

Deaths: 0 deaths

Vehicle Gel

Serious events: 0 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	GI148512 n=178 participants at risk 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.	Vehicle Gel n=182 participants at risk 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.
Infections and infestations Nasopharyngitis	22.5% 40/178 • Serious adverse events (SAEs) and non-serious AEs collected from the start of study treatment until Week 12 or premature withdrawal are reported. 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.	29.1% 53/182 • Serious adverse events (SAEs) and non-serious AEs collected from the start of study treatment until Week 12 or premature withdrawal are reported. 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.
Skin and subcutaneous tissue disorders Dry skin	9.0% 16/178 • Serious adverse events (SAEs) and non-serious AEs collected from the start of study treatment until Week 12 or premature withdrawal are reported. 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.	3.3% 6/182 • Serious adverse events (SAEs) and non-serious AEs collected from the start of study treatment until Week 12 or premature withdrawal are reported. 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.
Skin and subcutaneous tissue disorders Dermatitis contact	9.0% 16/178 • Serious adverse events (SAEs) and non-serious AEs collected from the start of study treatment until Week 12 or premature withdrawal are reported. 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.	1.1% 2/182 • Serious adverse events (SAEs) and non-serious AEs collected from the start of study treatment until Week 12 or premature withdrawal are reported. 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.
Skin and subcutaneous tissue disorders Pruritus	7.3% 13/178 • Serious adverse events (SAEs) and non-serious AEs collected from the start of study treatment until Week 12 or premature withdrawal are reported. 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.	2.2% 4/182 • Serious adverse events (SAEs) and non-serious AEs collected from the start of study treatment until Week 12 or premature withdrawal are reported. 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.
Skin and subcutaneous tissue disorders Erythema	5.6% 10/178 • Serious adverse events (SAEs) and non-serious AEs collected from the start of study treatment until Week 12 or premature withdrawal are reported. 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.	1.1% 2/182 • Serious adverse events (SAEs) and non-serious AEs collected from the start of study treatment until Week 12 or premature withdrawal are reported. 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.
General disorders Facial pain	10.7% 19/178 • Serious adverse events (SAEs) and non-serious AEs collected from the start of study treatment until Week 12 or premature withdrawal are reported. 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.	1.1% 2/182 • Serious adverse events (SAEs) and non-serious AEs collected from the start of study treatment until Week 12 or premature withdrawal are reported. 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.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	GI148512 n=178 Participants 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.	Vehicle Gel n=182 Participants 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.
Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12 Total, Week 1, n=175, 179	-22.26 Percent change in lesion counts Standard Error 1.705	-12.07 Percent change in lesion counts Standard Error 1.676
Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12 Total, Week 2, n=177, 182	-36.17 Percent change in lesion counts Standard Error 2.052	-19.63 Percent change in lesion counts Standard Error 2.014
Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12 Total, Week 12, n=177,182	-59.79 Percent change in lesion counts Standard Error 2.754	-30.15 Percent change in lesion counts Standard Error 2.704
Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12 IL, Week 4, n=177, 182	-54.38 Percent change in lesion counts Standard Error 2.696	-30.54 Percent change in lesion counts Standard Error 2.647
Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12 NIL, Week 2, n=177, 182	-29.78 Percent change in lesion counts Standard Error 2.570	-17.93 Percent change in lesion counts Standard Error 2.523
Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12 NIL, Week 4, n=177, 182	-39.88 Percent change in lesion counts Standard Error 2.584	-19.72 Percent change in lesion counts Standard Error 2.536
Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12 NIL, Week 8, n=177, 182	-51.64 Percent change in lesion counts Standard Error 2.923	-25.86 Percent change in lesion counts Standard Error 2.869
Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12 Total, Week 4, n=177, 182	-45.43 Percent change in lesion counts Standard Error 2.177	-24.50 Percent change in lesion counts Standard Error 2.137
Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12 Total, Week 8, n=177, 182	-55.40 Percent change in lesion counts Standard Error 2.378	-27.43 Percent change in lesion counts Standard Error 2.334
Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12 IL, Week 1, n=175, 179	-30.85 Percent change in lesion counts Standard Error 2.379	-16.78 Percent change in lesion counts Standard Error 2.338
Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12 IL, Week 2, n=177, 182	-46.40 Percent change in lesion counts Standard Error 2.720	-20.74 Percent change in lesion counts Standard Error 2.670
Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12 IL, Week 8, n=177, 182	-60.33 Percent change in lesion counts Standard Error 2.810	-28.02 Percent change in lesion counts Standard Error 2.759
Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12 IL, Week 12, n=177,182	-64.68 Percent change in lesion counts Standard Error 2.859	-36.16 Percent change in lesion counts Standard Error 2.807
Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12 NIL, Week 1, n=175, 179	-16.99 Percent change in lesion counts Standard Error 2.127	-7.92 Percent change in lesion counts Standard Error 2.091
Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12 NIL, Week 12, n=177,182	-55.17 Percent change in lesion counts Standard Error 3.533	-26.36 Percent change in lesion counts Standard Error 3.468