Dose Range Study of CD5789 in Acne Vulgaris | NCT01616654

NCT01616654

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CD5789 25 mcg/g Cream	Experimental	Participants randomized in stratum 1, 2 and 3 were applied with 25 mcg/g CD5789 cream, once daily for 12 weeks.	Drug: CD5789 25 µg/g cream
CD5789 50 mcg/g Cream	Experimental	Participants randomized in stratum 1, 2 and 3 were applied with 50 mcg/g CD5789 50 once daily for 12 weeks.	Drug: CD5789 50 µg/g cream
CD5789 100 mcg/g Cream	Active Comparator	Participants randomized in stratum 1, 2 and 3 were applied with 100 mcg/g CD5789 cream, once daily for 12 weeks.	Drug: CD5789 100 µg/g cream
Tazarotene 0.1% Gel	Placebo Comparator	Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.	Drug: Tazarotene 0.1% gel
Vehicle Cream	Experimental	Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.	Drug: Vehicle cream

Name	Type	Description	Arm Group Labels	Other Names
CD5789 25 µg/g cream	Drug	CD5789 25 µg/g cream applied once daily	CD5789 25 mcg/g Cream

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Success Rate 1 (SR1)	Success Rate 1 was defined as percentage of participants who achieved at least a two-point reduction in the Investigator Global Assessment (IGA) scale from baseline at week 12. Evaluation of acne was performed by the investigator based on the following 5 point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).	From Baseline at Week 12
Absolute Change From Baseline in Total Lesion Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)	The lesion counts were performed by the Investigator. Total lesion counts was the sum of inflammatory, non-inflammatory lesions and nodules. All missing values were imputed by LOCF.	Baseline, Week 12
Percentage Change From Baseline in Total Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)	The lesion counts were performed by the Investigator. Total lesion counts was the sum of inflammatory, non-inflammatory lesions and nodules. All missing values were imputed by LOCF.	Baseline, Week 12

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Success Rate 2 (SR2)	Success Rate 2 (SR2) was defined as the percentage of participants rated "Clear" (Grade 0) or "Almost clear" (Grade 1) with at least a two-point reduction on the IGA scale from Baseline to Week 12. Evaluation of acne was performed by the investigator based on the following 5 point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, higher score indicated higher severity. All missing values were imputed by LOCF.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Michael Graeber, M.D.	Galderma R&D, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Total Skin and Beauty Dermatology Center, PC		Birmingham	Alabama	35205	United States
Parexel Early Phase

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	CD5789 25 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
FG001	CD5789 50 mcg/g Cream

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.

Analysis was performed on Intent to treat (ITT) population that included all participants who were randomized and to whom study drug was dispensed.

Arm/Group Information

ID	Title	Description
BG000	CD5789 25 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
BG001	CD5789 50 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
BG002	CD5789 100 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
BG003	Tazarotene 0.1% Gel	Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
BG004	Vehicle Cream	Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00018.1± 5.26 BG00118.2± 4.76 BG00218.3± 5.59 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00015 BG0018 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Success Rate 1 (SR1)

Success Rate 1 was defined as percentage of participants who achieved at least a two-point reduction in the Investigator Global Assessment (IGA) scale from baseline at week 12. Evaluation of acne was performed by the investigator based on the following 5 point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).

Analysis was performed on Intent to treat (ITT) population that included all subjects who were randomized and to whom study drug was dispensed.

Posted

Number

percentage of participants

From Baseline at Week 12

ID	Title	Description
OG000	CD5789 25 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
OG001	CD5789 50 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
OG002	CD5789 100 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
OG003	Tazarotene 0.1% Gel	Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
OG004	CD5789 Vehicle Cream	Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.

Units	Counts
Participants	OG00061 OG00161 OG00260 OG003

Title

Denominators

Categories

Title	Measurements
	OG00029.51 OG00132.79 OG00226.67 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG004	The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.	Cochran-Mantel-Haenszel		0.096		Percentage difference	13.115			2-Sided	95	-3.266	29.495					Superiority
OG001 OG004

Primary

Absolute Change From Baseline in Total Lesion Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)

The lesion counts were performed by the Investigator. Total lesion counts was the sum of inflammatory, non-inflammatory lesions and nodules. All missing values were imputed by LOCF.

Analysis was performed on ITT population.

Posted

Least Squares Mean

Standard Error

lesion count

Baseline, Week 12

ID	Title	Description
OG000	CD5789 25 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
OG001	CD5789 50 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
OG002	CD5789 100 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
OG003	Tazarotene 0.1% Gel

Primary

Percentage Change From Baseline in Total Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)

The lesion counts were performed by the Investigator. Total lesion counts was the sum of inflammatory, non-inflammatory lesions and nodules. All missing values were imputed by LOCF.

Analysis was performed on ITT population.

Posted

Mean

Standard Deviation

percentage change

Baseline, Week 12

ID	Title	Description
OG000	CD5789 25 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
OG001	CD5789 50 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
OG002	CD5789 100 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
OG003	Tazarotene 0.1% Gel

Secondary

Percentage of Participants With Success Rate 2 (SR2)

Success Rate 2 (SR2) was defined as the percentage of participants rated "Clear" (Grade 0) or "Almost clear" (Grade 1) with at least a two-point reduction on the IGA scale from Baseline to Week 12. Evaluation of acne was performed by the investigator based on the following 5 point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, higher score indicated higher severity. All missing values were imputed by LOCF.

Analysis was performed on ITT population.

Posted

Number

percentage of participants

From Baseline to Week 12

ID	Title	Description
OG000	CD5789 25 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
OG001	CD5789 50 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
OG002	CD5789 100 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.

Secondary

Absolute Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)

The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 1 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). All missing values were imputed by LOCF.

Analysis was performed on ITT population.

Posted

Mean

Standard Deviation

lesion count

Baseline, Week 12

ID	Title	Description
OG000	CD5789 25 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
OG001	CD5789 50 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
OG002	CD5789 100 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.

Secondary

Percentage Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)

Analysis was performed on ITT population.

Posted

Mean

Standard Deviation

percentage change

Baseline, Week 12

ID	Title	Description
OG000	CD5789 25 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.
OG001	CD5789 50 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.
OG002	CD5789 100 mcg/g Cream

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CD5789 25 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.	61	1	61	15	61
EG001	CD5789 50 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.	61	1	61	17	61
EG002	CD5789 100 mcg/g Cream	Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.	60	0	60	23	60
EG003	Tazarotene 0.1% Gel	Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.	61	0	61	24	61
EG004	CD5789 Vehicle Cream	Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.	61	1	61	18	61

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 13.0	Systematic Assessment		EG0001 events1 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG0030 events0 affected61 at risk EG004
Depression	Psychiatric disorders	MedDRA 13.0	Systematic Assessment		EG0000 events0 affected61 at risk EG0011 events1 affected61 at risk EG0020 events0 affected60 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0004 events4 affected61 at risk EG0011 events1 affected61 at risk EG0025 events5 affected60 at risk EG0035 events5 affected61 at risk EG0041 events1 affected61 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected61 at risk EG0013 events3 affected61 at risk EG0024 events4 affected60 at risk EG003
Influenza	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected61 at risk EG0010 events0 affected61 at risk EG0022 events2 affected60 at risk EG003
Infectious mononucleosis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0011 events1 affected61 at risk EG0021 events1 affected60 at risk EG003
Folliculitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Furuncle	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Rhinitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0011 events1 affected61 at risk EG0020 events0 affected60 at risk EG003
Sinusitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Streptococcal infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0011 events1 affected61 at risk EG0020 events0 affected60 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0011 events1 affected61 at risk EG0020 events0 affected60 at risk EG003
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0027 events6 affected60 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0022 events2 affected60 at risk EG003
Skin burning sensation	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0011 events1 affected61 at risk EG0020 events0 affected60 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0021 events1 affected60 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0021 events1 affected60 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0021 events1 affected60 at risk EG003
Pityriasis alba	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected61 at risk EG0011 events1 affected61 at risk EG0020 events0 affected60 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0021 events1 affected60 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Dyshidrosis	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0011 events1 affected61 at risk EG0020 events0 affected60 at risk EG003
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0021 events1 affected60 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0021 events1 affected60 at risk EG003
Urticaria papular	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Headache	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0003 events2 affected61 at risk EG0012 events2 affected61 at risk EG0021 events1 affected60 at risk EG003
Tension headache	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0011 events1 affected61 at risk EG0021 events1 affected60 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Joint sprain	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0021 events1 affected60 at risk EG003
Muscle injury	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0021 events1 affected60 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0011 events1 affected61 at risk EG0020 events0 affected60 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Tooth impacted	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Electrocardiogram abnormal	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Alanine aminotransferase decreased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Bilirubin conjugated increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Blood glucose increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Blood uric acid decreased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Electrocardiogram ST segment elevation	Investigations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Electrocardiogram T wave inversion	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Red blood cell count decreased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Atrioventricular block first degree	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0011 events1 affected61 at risk EG0020 events0 affected60 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0011 events1 affected61 at risk EG0020 events0 affected60 at risk EG003
Right ventricular hypertrophy	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0011 events1 affected61 at risk EG0020 events0 affected60 at risk EG003
Sinus arrhythmia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected61 at risk EG0010 events0 affected61 at risk EG0021 events1 affected60 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Allergy to arthropod bite	Immune system disorders	MedDRA 13.0	Systematic Assessment	EG0002 events1 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Conjunctivitis	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Eye haemorrhage	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Pyrexia	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0011 events1 affected61 at risk EG0020 events0 affected60 at risk EG003
Depression	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0011 events1 affected61 at risk EG0020 events0 affected60 at risk EG003
Oppositional defiant disorder	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0011 events1 affected61 at risk EG0020 events0 affected60 at risk EG003
Hypertension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0012 events1 affected61 at risk EG0020 events0 affected60 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected61 at risk EG0010 events0 affected61 at risk EG0020 events0 affected60 at risk EG003

ID	Term
D000152	Acne Vulgaris

ID	Term
C000629420	trifarotene
C086827	tazarotene
D005782	Gels

The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction

Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.

Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.