Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopu... | NCT01025635

ID	Type	Description	Link
1403120	Other Identifier	Company internal

Status Module

Name	Class
Bayer	INDUSTRY

Label	Type	Description	Intervention Names
Azelaic acid foam, 15% (BAY39-6251)	Experimental	Participants received azelaic acid foam, 15% topically twice daily for 12 weeks	Drug: Azelaic acid foam 15%
Vehicle foam	Placebo Comparator	Participants received vehicle foam topically twice daily for 12 weeks	Drug: Vehicle foam

Name	Type	Description	Arm Group Labels	Other Names
Azelaic acid foam 15%	Drug	Applied topically twice daily for 12 weeks	Azelaic acid foam, 15% (BAY39-6251)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)	The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal.	At End of treatment (up to 12 weeks) (LOCF)
Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)		Baseline and End of treatment (up to 12 weeks) (LOCF)

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)		At End of treatment (up to 12 weeks) (LOCF)
Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF)

Eligibility Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35209	United States

PubMed Identifier	Type	Citation	Retractions
24416747	Background	Draelos ZD, Elewski B, Staedtler G, Havlickova B. Azelaic acid foam 15% in the treatment of papulopustular rosacea: a randomized, double-blind, vehicle-controlled study. Cutis. 2013 Dec;92(6):306-17.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Azelaic Acid Foam, 15% (BAY39-6251)	Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
FG001	Vehicle Foam	Participants received vehicle foam topically twice daily for 12 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Subjects achieving a clear, minimal, or mild IGA at the end of treatment were considered as 'responder'. Subjects with an IGA of moderate or severe at the end of treatment were considered as 'non-responder'. Subjects who prematurely withdraw from study treatment because of lack of efficacy were coded as 'non-responders'.

ID	Title	Description
BG000	Azelaic Acid Foam, 15% (BAY39-6251)	Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
BG001	Vehicle Foam	Participants received vehicle foam topically twice daily for 12 weeks
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000198 BG001203 BG002401

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
	BG00048.1± 12.23 BG00148.9± 11.65 BG00248.5± 11.93

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000155 BG001143 BG002

Previous duration of rosacea

Mean

Standard Deviation

Months

Title

Denominators

Categories

Title	Measurements
	BG000121.4± 113.38 BG001126.3± 103.81 BG002

Investigator's Global Assessment (IGA) score at Baseline

IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 4 - Moderate; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).

Mean

Standard Deviation

Scores on a scale

Title

Denominators

Categories

Title	Measurements
	BG0004.3± 0.68 BG001

Number of inflammatory lesions per participant at Baseline

Mean

Standard Deviation

Inflammatory lesions

Title

Denominators

Categories

Title	Measurements
	BG00021.6± 9.91 BG00120.4± 8.83 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 Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)

The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal.

Posted

Number

Percentage of participants

At End of treatment (up to 12 weeks) (LOCF)

ID	Title	Description
OG000	Azelaic Acid Foam, 15% (BAY39-6251)	Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
OG001	Vehicle Foam	Participants received vehicle foam topically twice daily for 12 weeks

Units	Counts
Participants	OG000198 OG001203

Title

Denominators

Categories

Title	Measurements
	OG00043.4 OG00132.5

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 OG001		Cochran-Mantel-Haenszel	study center adjusted	0.017														Superiority or Other (legacy)

Primary

Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)

Posted

Mean

Standard Deviation

Inflammatory lesions

Baseline and End of treatment (up to 12 weeks) (LOCF)

ID	Title	Description
OG000	Azelaic Acid Foam, 15% (BAY39-6251)	Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
OG001	Vehicle Foam	Participants received vehicle foam topically twice daily for 12 weeks

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)

Posted

Mean

Standard Deviation

Percentage of Inflammatory lesions

At End of treatment (up to 12 weeks) (LOCF)

ID	Title	Description
OG000	Azelaic Acid Foam, 15% (BAY39-6251)	Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
OG001	Vehicle Foam	Participants received vehicle foam topically twice daily for 12 weeks

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF)

Posted

Number

Percentage of participants

At End of treatment (up to 12 weeks) (LOCF)

ID	Title	Description
OG000	Azelaic Acid Foam, 15% (BAY39-6251)	Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
OG001	Vehicle Foam	Participants received vehicle foam topically twice daily for 12 weeks

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vertigo	Ear and labyrinth disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Hypothyroidism	Endocrine disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Constipation	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected198 at risk EG0010 events0 affected203 at risk
Food poisoning	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Gastritis	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Nausea	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0003 events3 affected198 at risk EG0011 events1 affected203 at risk
Toothache	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0011 events1 affected203 at risk
Vomiting	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Application site erythema	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Application site pain	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0009 events9 affected198 at risk EG0014 events3 affected203 at risk
Application site pruritus	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0003 events3 affected198 at risk EG0010 events0 affected203 at risk
Chest pain	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0012 events2 affected203 at risk
Cyst	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Feeling hot	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Oedema peripheral	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Pain	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0007 events7 affected198 at risk EG0011 events1 affected203 at risk
Pyrexia	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Swelling	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Tenderness	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0002 events1 affected198 at risk EG0010 events0 affected203 at risk
Application site dryness	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Application site paraesthesia	General disorders	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected198 at risk EG0011 events1 affected203 at risk
Bronchitis	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0003 events3 affected198 at risk EG0010 events0 affected203 at risk
Fungal infection	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Influenza	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Nasopharyngitis	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0007 events7 affected198 at risk EG0016 events6 affected203 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0012 events2 affected203 at risk
Rhinitis	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Sinusitis	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected198 at risk EG0012 events2 affected203 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected198 at risk EG0014 events3 affected203 at risk
Urinary tract infection	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected198 at risk EG0010 events0 affected203 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected198 at risk EG0010 events0 affected203 at risk
Lymph gland infection	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Staphylococcal infection	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Oral herpes	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Sunburn	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected198 at risk EG0010 events0 affected203 at risk
Whiplash injury	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0002 events1 affected198 at risk EG0010 events0 affected203 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0002 events1 affected198 at risk EG0011 events1 affected203 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Blood pressure increased	Investigations	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0011 events1 affected203 at risk
Heart rate irregular	Investigations	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Gout	Metabolism and nutrition disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0013 events3 affected203 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0012 events1 affected203 at risk
Burning sensation	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0003 events3 affected198 at risk EG0010 events0 affected203 at risk
Headache	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG00021 events9 affected198 at risk EG0013 events2 affected203 at risk
Nerve compression	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Paraesthesia	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Sciatica	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Tension headache	Nervous system disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Insomnia	Psychiatric disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected198 at risk EG0011 events1 affected203 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0003 events3 affected198 at risk EG0012 events2 affected203 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0011 events1 affected203 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Nasal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Non-systematic Assessment	EG0002 events2 affected198 at risk EG0011 events1 affected203 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0012 events1 affected203 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Eczema asteatotic	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0011 events1 affected203 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0004 events4 affected198 at risk EG0010 events0 affected203 at risk
Rash morbilliform	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Telangiectasia	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0002 events1 affected198 at risk EG0010 events0 affected203 at risk
Dental care	Surgical and medical procedures	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Mammoplasty	Surgical and medical procedures	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Flushing	Vascular disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Azelaic Acid Foam, 15% (BAY39-6251)	Participants received azelaic acid foam, 15% topically twice daily for 12 weeks			1	198	68	198
EG001	Vehicle Foam	Participants received vehicle foam topically twice daily for 12 weeks			3	203	48	203

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cellulitis	Infections and infestations	MedDRA (12.1)	Non-systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected203 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Non-systematic Assessment	EG0000 events0 affected198 at risk EG0011 events1 affected203 at risk