Trial Outcomes & Findings for Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea (NCT NCT01025635)
NCT ID: NCT01025635
Last Updated: 2020-03-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
401 participants
Primary outcome timeframe
At End of treatment (up to 12 weeks) (LOCF)
Results posted on
2020-03-31
Participant Flow
Participant milestones
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
198
|
203
|
|
Overall Study
COMPLETED
|
175
|
178
|
|
Overall Study
NOT COMPLETED
|
23
|
25
|
Reasons for withdrawal
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
7
|
|
Overall Study
Protocol Violation
|
4
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
9
|
13
|
|
Overall Study
Reason not known
|
4
|
2
|
Baseline Characteristics
Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea
Baseline characteristics by cohort
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=198 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=203 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
Total
n=401 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.1 Years
STANDARD_DEVIATION 12.23 • n=93 Participants
|
48.9 Years
STANDARD_DEVIATION 11.65 • n=4 Participants
|
48.5 Years
STANDARD_DEVIATION 11.93 • n=27 Participants
|
|
Sex: Female, Male
Female
|
155 Participants
n=93 Participants
|
143 Participants
n=4 Participants
|
298 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
103 Participants
n=27 Participants
|
|
Previous duration of rosacea
|
121.4 Months
STANDARD_DEVIATION 113.38 • n=93 Participants
|
126.3 Months
STANDARD_DEVIATION 103.81 • n=4 Participants
|
123.8 Months
STANDARD_DEVIATION 108.53 • n=27 Participants
|
|
Investigator's Global Assessment (IGA) score at Baseline
|
4.3 Scores on a scale
STANDARD_DEVIATION 0.68 • n=93 Participants
|
4.1 Scores on a scale
STANDARD_DEVIATION 0.51 • n=4 Participants
|
4.2 Scores on a scale
STANDARD_DEVIATION 0.60 • n=27 Participants
|
|
Number of inflammatory lesions per participant at Baseline
|
21.6 Inflammatory lesions
STANDARD_DEVIATION 9.91 • n=93 Participants
|
20.4 Inflammatory lesions
STANDARD_DEVIATION 8.83 • n=4 Participants
|
21.0 Inflammatory lesions
STANDARD_DEVIATION 9.38 • n=27 Participants
|
PRIMARY outcome
Timeframe: At End of treatment (up to 12 weeks) (LOCF)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.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=198 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=203 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)
|
43.4 Percentage of participants
|
32.5 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline and End of treatment (up to 12 weeks) (LOCF)Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=198 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=203 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)
|
-13.4 Inflammatory lesions
Standard Deviation 10.39
|
-9.5 Inflammatory lesions
Standard Deviation 9.73
|
SECONDARY outcome
Timeframe: At End of treatment (up to 12 weeks) (LOCF)Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=198 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=203 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)
|
-62.5 Percentage of Inflammatory lesions
Standard Deviation 35.66
|
-47.8 Percentage of Inflammatory lesions
Standard Deviation 41.28
|
SECONDARY outcome
Timeframe: At End of treatment (up to 12 weeks) (LOCF)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'.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=198 Participants
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=203 Participants
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF)
|
69.2 Percentage of participants
|
57.6 Percentage of participants
|
Adverse Events
Azelaic Acid Foam, 15% (BAY39-6251)
Serious events: 1 serious events
Other events: 68 other events
Deaths: 0 deaths
Vehicle Foam
Serious events: 3 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=198 participants at risk
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=203 participants at risk
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
Other adverse events
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=198 participants at risk
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
|
Vehicle Foam
n=203 participants at risk
Participants received vehicle foam topically twice daily for 12 weeks
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Gastrointestinal disorders
Constipation
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
2/198 • Number of events 2
|
0.00%
0/203
|
|
Gastrointestinal disorders
Food poisoning
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Gastrointestinal disorders
Gastritis
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Gastrointestinal disorders
Nausea
|
1.5%
3/198 • Number of events 3
|
0.49%
1/203 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.51%
1/198 • Number of events 1
|
0.49%
1/203 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
General disorders
Application site erythema
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
General disorders
Application site pain
|
4.5%
9/198 • Number of events 9
|
1.5%
3/203 • Number of events 4
|
|
General disorders
Application site pruritus
|
1.5%
3/198 • Number of events 3
|
0.00%
0/203
|
|
General disorders
Chest pain
|
0.00%
0/198
|
0.99%
2/203 • Number of events 2
|
|
General disorders
Cyst
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
General disorders
Feeling hot
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
General disorders
Pain
|
3.5%
7/198 • Number of events 7
|
0.49%
1/203 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
General disorders
Swelling
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
General disorders
Tenderness
|
0.51%
1/198 • Number of events 2
|
0.00%
0/203
|
|
General disorders
Application site dryness
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
General disorders
Application site paraesthesia
|
1.0%
2/198 • Number of events 2
|
0.49%
1/203 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
1.5%
3/198 • Number of events 3
|
0.00%
0/203
|
|
Infections and infestations
Fungal infection
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
3.5%
7/198 • Number of events 7
|
3.0%
6/203 • Number of events 6
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/198
|
0.99%
2/203 • Number of events 2
|
|
Infections and infestations
Rhinitis
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
1.0%
2/198 • Number of events 2
|
0.99%
2/203 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
1.0%
2/198 • Number of events 2
|
1.5%
3/203 • Number of events 4
|
|
Infections and infestations
Urinary tract infection
|
1.0%
2/198 • Number of events 2
|
0.00%
0/203
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.0%
2/198 • Number of events 2
|
0.00%
0/203
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Infections and infestations
Oral herpes
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Injury, poisoning and procedural complications
Sunburn
|
1.0%
2/198 • Number of events 2
|
0.00%
0/203
|
|
Injury, poisoning and procedural complications
Whiplash injury
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.51%
1/198 • Number of events 2
|
0.00%
0/203
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.51%
1/198 • Number of events 2
|
0.49%
1/203 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Investigations
Blood pressure increased
|
0.51%
1/198 • Number of events 1
|
0.49%
1/203 • Number of events 1
|
|
Investigations
Heart rate irregular
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/198
|
1.5%
3/203 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/198
|
0.49%
1/203 • Number of events 2
|
|
Nervous system disorders
Burning sensation
|
1.5%
3/198 • Number of events 3
|
0.00%
0/203
|
|
Nervous system disorders
Headache
|
4.5%
9/198 • Number of events 21
|
0.99%
2/203 • Number of events 3
|
|
Nervous system disorders
Nerve compression
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Nervous system disorders
Paraesthesia
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Nervous system disorders
Sciatica
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Nervous system disorders
Tension headache
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.0%
2/198 • Number of events 2
|
0.49%
1/203 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.5%
3/198 • Number of events 3
|
0.99%
2/203 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.51%
1/198 • Number of events 1
|
0.49%
1/203 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal disorder
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.0%
2/198 • Number of events 2
|
0.49%
1/203 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/198
|
0.49%
1/203 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.51%
1/198 • Number of events 1
|
0.49%
1/203 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
4/198 • Number of events 4
|
0.00%
0/203
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.51%
1/198 • Number of events 2
|
0.00%
0/203
|
|
Surgical and medical procedures
Dental care
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Surgical and medical procedures
Mammoplasty
|
0.51%
1/198 • Number of events 1
|
0.00%
0/203
|
|
Vascular disorders
Flushing
|
0.00%
0/198
|
0.49%
1/203 • Number of events 1
|
Additional Information
Therapeutic Area Head
Bayer HealthCare Pharmaceuticals, Inc. (formerly Intendis GmbH)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator may publish the results of Study only after review, comment and approval by Intendis. At least sixty (60) days prior to submitting a manuscript to a publisher or other outside persons (i.e., reviewer(s)) or prior to any public presentation), a copy of the manuscript or presentation will be provided to Intendis by the Investigator for review and comment. No publication of confidential information shall be made without Intendis' prior written consent.
- Publication restrictions are in place
Restriction type: OTHER