Trial Outcomes & Findings for A Efficacy and Safety of Duac™Compared With Clindamycin Phosphate Gel in the Treatment of Mild to Moderate Acne Vulgaris (NCT NCT01915732)

NCT ID: NCT01915732

Last Updated: 2017-02-28

Results Overview

The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1018 participants
• Primary outcome timeframe: Baseline (Week 0) and Week 12
• Results posted on: 2017-02-28

Participant Flow

Participant milestones

Measure	Duac Once Daily Gel Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.	Dalin Gel Participants topically applied Dalin Gel (clindamycin phosphate \[equivalent to 1% clindamycin\]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Overall Study STARTED	500	516
Overall Study COMPLETED	430	445
Overall Study NOT COMPLETED	70	71

Reasons for withdrawal

Measure	Duac Once Daily Gel Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.	Dalin Gel Participants topically applied Dalin Gel (clindamycin phosphate \[equivalent to 1% clindamycin\]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Overall Study Withdrawal by Subject	18	18
Overall Study Failure to Meet Randomization Criteria	1	0
Overall Study Adverse Event	12	4
Overall Study Protocol Violation	5	5
Overall Study Lack of Efficacy	6	11
Overall Study Lost to Follow-up	22	26
Overall Study Par. Improved, Voluntary (Vol) exit	1	0
Overall Study Par. Conscious Ineffective Vol Exit	1	0
Overall Study Drug Release Error	1	0
Overall Study Recovered	1	0
Overall Study Pregnancy	1	0
Overall Study Poor Perceived Efficacy	1	0
Overall Study Par. Unable to Come to the Hospital	0	1
Overall Study Got Well	0	1
Overall Study Par. not Willing to Continue Treatment	0	1
Overall Study Par. Refused to Hospital Visits	0	1
Overall Study Job Transfer	0	1
Overall Study Improper Facial Procedure	0	1
Overall Study Poor Conscious Effect	0	1

Baseline Characteristics

A Efficacy and Safety of Duac™Compared With Clindamycin Phosphate Gel in the Treatment of Mild to Moderate Acne Vulgaris

Baseline characteristics by cohort

Measure	Duac Once Daily Gel n=500 Participants Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.	Dalin Gel n=516 Participants Participants topically applied Dalin Gel (clindamycin phosphate \[equivalent to 1% clindamycin\]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.	Total n=1016 Participants Total of all reporting groups
Age, Continuous	23.4 Years STANDARD_DEVIATION 4.64 • n=5 Participants	23.3 Years STANDARD_DEVIATION 4.29 • n=7 Participants	23.4 Years STANDARD_DEVIATION 4.46 • n=5 Participants
Gender Female	382 Participants n=5 Participants	383 Participants n=7 Participants	765 Participants n=5 Participants
Gender Male	118 Participants n=5 Participants	133 Participants n=7 Participants	251 Participants n=5 Participants
Race/Ethnicity, Customized Asian	500 Participants n=5 Participants	515 Participants n=7 Participants	1015 Participants n=5 Participants
Race/Ethnicity, Customized White	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) and Week 12

Population: Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication.

The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data.

Outcome measures

Measure	Duac Once Daily Gel n=484 Participants Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.	Dalin Gel n=499 Participants Participants topically applied Dalin Gel (clindamycin phosphate \[equivalent to 1% clindamycin\]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Absolute Change in Total Lesion Count From Baseline to Week 12	-55.7 Change in lesion count Standard Error 1.05	-51.2 Change in lesion count Standard Error 1.03

PRIMARY outcome

Timeframe: Baseline (Week 0) and Week 12

Population: Per-Protocol (PP) Population: all participants included in the ITT Population who did not have a noteworthy protocol deviation that influenced effect.

The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data.

Outcome measures

Measure	Duac Once Daily Gel n=433 Participants Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.	Dalin Gel n=449 Participants Participants topically applied Dalin Gel (clindamycin phosphate \[equivalent to 1% clindamycin\]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Absolute Change in Total Lesion Count From Baseline to Week 12	-56.7 Change in lesion count Standard Error 0.97	-52.1 Change in lesion count Standard Error 0.96

PRIMARY outcome

Timeframe: Baseline (Week 0) and Week 12

Population: ITT Population

ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.

Outcome measures

Measure	Duac Once Daily Gel n=500 Participants Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.	Dalin Gel n=516 Participants Participants topically applied Dalin Gel (clindamycin phosphate \[equivalent to 1% clindamycin\]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12	151 Participants	117 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) and Week 12

Population: PP Population

ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data .

Outcome measures

Measure	Duac Once Daily Gel n=442 Participants Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.	Dalin Gel n=461 Participants Participants topically applied Dalin Gel (clindamycin phosphate \[equivalent to 1% clindamycin\]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12	142 Participants	110 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 12

Population: ITT Population

The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.

Outcome measures

Measure	Duac Once Daily Gel n=484 Participants Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.	Dalin Gel n=499 Participants Participants topically applied Dalin Gel (clindamycin phosphate \[equivalent to 1% clindamycin\]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12 IL	-20.6 Lesions Standard Error 0.36	-19.7 Lesions Standard Error 0.35
Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12 NIL	-35.0 Lesions Standard Error 0.83	-31.6 Lesions Standard Error 0.82

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 12

Population: PP Population

The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.

Outcome measures

Measure	Duac Once Daily Gel n=433 Participants Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.	Dalin Gel n=449 Participants Participants topically applied Dalin Gel (clindamycin phosphate \[equivalent to 1% clindamycin\]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12 IL	-20.9 Lesions Standard Error 0.34	-19.9 Lesions Standard Error 0.34
Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12 NIL	-35.7 Lesions Standard Error 0.78	-32.3 Lesions Standard Error 0.77

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 12

Population: ITT Population

The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones) and total lesions (the sum of ILs and NILs)at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.

Outcome measures

Measure	Duac Once Daily Gel n=484 Participants Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.	Dalin Gel n=499 Participants Participants topically applied Dalin Gel (clindamycin phosphate \[equivalent to 1% clindamycin\]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12 IL	-0.78 Percent change in lesions Standard Error 0.013	-0.75 Percent change in lesions Standard Error 0.013
Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12 NIL	-0.67 Percent change in lesions Standard Error 0.018	-0.60 Percent change in lesions Standard Error 0.018
Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12 Total	-0.72 Percent change in lesions Standard Error 0.013	-0.67 Percent change in lesions Standard Error 0.013

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 12

Population: PP Population

The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones) and total lesions (the sum of ILs and NILs)at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.

Outcome measures

Measure	Duac Once Daily Gel n=433 Participants Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.	Dalin Gel n=449 Participants Participants topically applied Dalin Gel (clindamycin phosphate \[equivalent to 1% clindamycin\]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12 IL	-0.80 Percent change in lesions Standard Error 0.012	-0.76 Percent change in lesions Standard Error 0.012
Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12 NIL	-0.70 Percent change in lesions Standard Error 0.018	-0.61 Percent change in lesions Standard Error 0.017
Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12 Total	-0.74 Percent change in lesions Standard Error 0.012	-0.68 Percent change in lesions Standard Error 0.012

SECONDARY outcome

Timeframe: Week 12

Population: ITT Population

The assessor evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.

Outcome measures

Measure	Duac Once Daily Gel n=500 Participants Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.	Dalin Gel n=516 Participants Participants topically applied Dalin Gel (clindamycin phosphate \[equivalent to 1% clindamycin\]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12	209 Participants	151 Participants

SECONDARY outcome

Timeframe: Week 12

Population: PP Population

The assessor evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.

Outcome measures

Measure	Duac Once Daily Gel n=442 Participants Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.	Dalin Gel n=461 Participants Participants topically applied Dalin Gel (clindamycin phosphate \[equivalent to 1% clindamycin\]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12	196 Participants	144 Participants

Adverse Events

Duac Once Daily Gel

Serious events: 1 serious events

Other events: 71 other events

Deaths: 0 deaths

Dalin Gel

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Measure	Duac Once Daily Gel n=500 participants at risk Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.	Dalin Gel n=516 participants at risk Participants topically applied Dalin Gel (clindamycin phosphate \[equivalent to 1% clindamycin\]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
Injury, poisoning and procedural complications Thermal burn	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.

Other adverse events

Measure	Duac Once Daily Gel n=500 participants at risk Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.	Dalin Gel n=516 participants at risk Participants topically applied Dalin Gel (clindamycin phosphate \[equivalent to 1% clindamycin\]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
General disorders Application site erythema	5.2% 26/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.78% 4/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
General disorders Application site pruritus	3.2% 16/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 3/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
General disorders Application site swelling	2.6% 13/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.58% 3/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
General disorders Application site erosion	1.2% 6/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
General disorders Application site pain	1.2% 6/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.39% 2/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
General disorders Application site dryness	0.80% 4/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
General disorders Application site warmth	0.80% 4/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
General disorders Application site dermatitis	0.60% 3/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
General disorders Application site reaction	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
General disorders Hyperhidrosis	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
General disorders Hyperpyrexia	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
General disorders Pyrexia	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.39% 2/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Nasopharyngitis	2.6% 13/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	2.5% 13/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Gastroenteritis	0.40% 2/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.39% 2/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Herpes simplex	0.40% 2/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Bronchitis	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Nasal abscess	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Onychomycosis	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Upper respiratory tract infection	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.78% 4/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Pharyngitis	0.00% 0/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Rash pustular	0.00% 0/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Rhinitis	0.00% 0/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Abdominal discomfort	0.60% 3/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Dry mouth	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain	0.00% 0/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Cheilitis	0.00% 0/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Constipation	0.00% 0/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	0.00% 0/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.97% 5/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Gingival bleeding	0.00% 0/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Haemorrhoids	0.00% 0/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Nausea	0.00% 0/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Retching	0.00% 0/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	0.40% 2/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.40% 2/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.39% 2/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Skin and subcutaneous tissue disorders Dermatitis contact	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Skin and subcutaneous tissue disorders Rash vesicular	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Skin and subcutaneous tissue disorders Urticaria	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Skin and subcutaneous tissue disorders Papule	0.00% 0/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Injury, poisoning and procedural complications Injury	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Nervous system disorders Headache	0.40% 2/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Nervous system disorders Dizziness	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Eye disorders Eyelid oedema	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Pain in jaw	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Reproductive system and breast disorders Dysmenorrhoea	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Surgical and medical procedures Eyelid operation	0.20% 1/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
Psychiatric disorders Insomnia	0.00% 0/500 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.	0.19% 1/516 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12). SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.

Additional Information

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• 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.
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