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Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea

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ClinicalTrials.gov Identifier: NCT01025635
Recruitment Status : Completed
First Posted : December 3, 2009
Results First Posted : July 1, 2013
Last Update Posted : May 5, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Papulopustular Rosacea
Interventions Drug: Azelaic acid foam 15%
Drug: Vehicle foam
Enrollment 401
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Azelaic Acid Foam, 15% (BAY39-6251) Vehicle Foam
Hide Arm/Group Description Participants received azelaic acid foam, 15% topically twice daily for 12 weeks Participants received vehicle foam topically twice daily for 12 weeks
Period Title: Overall Study
Started 198 203
Completed 175 178
Not Completed 23 25
Reason Not Completed
Withdrawal by Subject             6             7
Protocol Violation             4             2
Lack of Efficacy             0             1
Lost to Follow-up             9             13
Reason not known             4             2
Arm/Group Title Azelaic Acid Foam, 15% (BAY39-6251) Vehicle Foam Total
Hide Arm/Group Description Participants received azelaic acid foam, 15% topically twice daily for 12 weeks Participants received vehicle foam topically twice daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 198 203 401
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 198 participants 203 participants 401 participants
48.1  (12.23) 48.9  (11.65) 48.5  (11.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 203 participants 401 participants
Female
155
  78.3%
143
  70.4%
298
  74.3%
Male
43
  21.7%
60
  29.6%
103
  25.7%
Previous duration of rosacea  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 198 participants 203 participants 401 participants
121.4  (113.38) 126.3  (103.81) 123.8  (108.53)
Investigator’s Global Assessment (IGA) score at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 198 participants 203 participants 401 participants
4.3  (0.68) 4.1  (0.51) 4.2  (0.60)
[1]
Measure Description: 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).
Number of inflammatory lesions per participant at Baseline  
Mean (Standard Deviation)
Unit of measure:  Inflammatory lesions
Number Analyzed 198 participants 203 participants 401 participants
21.6  (9.91) 20.4  (8.83) 21.0  (9.38)
1.Primary Outcome
Title Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)
Hide Description 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.
Time Frame At End of treatment (up to 12 weeks) (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azelaic Acid Foam, 15% (BAY39-6251) Vehicle Foam
Hide Arm/Group Description:
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
Participants received vehicle foam topically twice daily for 12 weeks
Overall Number of Participants Analyzed 198 203
Measure Type: Number
Unit of Measure: Percentage of participants
43.4 32.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azelaic Acid Foam, 15% (BAY39-6251), Vehicle Foam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments study center adjusted
2.Primary Outcome
Title Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)
Hide Description [Not Specified]
Time Frame Baseline and End of treatment (up to 12 weeks) (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azelaic Acid Foam, 15% (BAY39-6251) Vehicle Foam
Hide Arm/Group Description:
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
Participants received vehicle foam topically twice daily for 12 weeks
Overall Number of Participants Analyzed 198 203
Mean (Standard Deviation)
Unit of Measure: Inflammatory lesions
-13.4  (10.39) -9.5  (9.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azelaic Acid Foam, 15% (BAY39-6251), Vehicle Foam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments with factors treatment group, study center, and baseline lesion count as covariate
3.Secondary Outcome
Title Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)
Hide Description [Not Specified]
Time Frame At End of treatment (up to 12 weeks) (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azelaic Acid Foam, 15% (BAY39-6251) Vehicle Foam
Hide Arm/Group Description:
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
Participants received vehicle foam topically twice daily for 12 weeks
Overall Number of Participants Analyzed 198 203
Mean (Standard Deviation)
Unit of Measure: Percentage of Inflammatory lesions
-62.5  (35.66) -47.8  (41.28)
4.Secondary Outcome
Title Percentage of Participants With Investigator’s Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF)
Hide Description 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’.
Time Frame At End of treatment (up to 12 weeks) (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azelaic Acid Foam, 15% (BAY39-6251) Vehicle Foam
Hide Arm/Group Description:
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
Participants received vehicle foam topically twice daily for 12 weeks
Overall Number of Participants Analyzed 198 203
Measure Type: Number
Unit of Measure: Percentage of participants
69.2 57.6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Azelaic Acid Foam, 15% (BAY39-6251) Vehicle Foam
Hide Arm/Group Description Participants received azelaic acid foam, 15% topically twice daily for 12 weeks Participants received vehicle foam topically twice daily for 12 weeks
All-Cause Mortality
Azelaic Acid Foam, 15% (BAY39-6251) Vehicle Foam
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Azelaic Acid Foam, 15% (BAY39-6251) Vehicle Foam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/198 (0.51%)      3/203 (1.48%)    
Infections and infestations     
Cellulitis * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Injury, poisoning and procedural complications     
Concussion * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Musculoskeletal and connective tissue disorders     
Intervertebral disc degeneration * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Thyroid cancer * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Azelaic Acid Foam, 15% (BAY39-6251) Vehicle Foam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   68/198 (34.34%)      48/203 (23.65%)    
Ear and labyrinth disorders     
Vertigo * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Endocrine disorders     
Hypothyroidism * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Gastrointestinal disorders     
Abdominal discomfort * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Constipation * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Diarrhoea * 1  2/198 (1.01%)  2 0/203 (0.00%)  0
Food poisoning * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Gastritis * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Nausea * 1  3/198 (1.52%)  3 1/203 (0.49%)  1
Toothache * 1  1/198 (0.51%)  1 1/203 (0.49%)  1
Vomiting * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Abdominal hernia * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
General disorders     
Application site erythema * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Application site pain * 1  9/198 (4.55%)  9 3/203 (1.48%)  4
Application site pruritus * 1  3/198 (1.52%)  3 0/203 (0.00%)  0
Chest pain * 1  0/198 (0.00%)  0 2/203 (0.99%)  2
Cyst * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Feeling hot * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Oedema peripheral * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Pain * 1  7/198 (3.54%)  7 1/203 (0.49%)  1
Pyrexia * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Swelling * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Tenderness * 1  1/198 (0.51%)  2 0/203 (0.00%)  0
Application site dryness * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Application site paraesthesia * 1  2/198 (1.01%)  2 1/203 (0.49%)  1
Infections and infestations     
Bronchitis * 1  3/198 (1.52%)  3 0/203 (0.00%)  0
Fungal infection * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Gastroenteritis viral * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Influenza * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Lower respiratory tract infection * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Nasopharyngitis * 1  7/198 (3.54%)  7 6/203 (2.96%)  6
Pharyngitis streptococcal * 1  0/198 (0.00%)  0 2/203 (0.99%)  2
Rhinitis * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Sinusitis * 1  2/198 (1.01%)  2 2/203 (0.99%)  2
Upper respiratory tract infection * 1  2/198 (1.01%)  2 3/203 (1.48%)  4
Urinary tract infection * 1  2/198 (1.01%)  2 0/203 (0.00%)  0
Viral upper respiratory tract infection * 1  2/198 (1.01%)  2 0/203 (0.00%)  0
Lymph gland infection * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Staphylococcal infection * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Vulvovaginal mycotic infection * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Oral herpes * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Gastrointestinal viral infection * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Injury, poisoning and procedural complications     
Sternal fracture * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Sunburn * 1  2/198 (1.01%)  2 0/203 (0.00%)  0
Whiplash injury * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Excoriation * 1  1/198 (0.51%)  2 0/203 (0.00%)  0
Muscle strain * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Contusion * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Skin laceration * 1  1/198 (0.51%)  2 1/203 (0.49%)  1
Procedural pain * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Ligament rupture * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Investigations     
Blood pressure increased * 1  1/198 (0.51%)  1 1/203 (0.49%)  1
Heart rate irregular * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Metabolism and nutrition disorders     
Gout * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Hypercholesterolaemia * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Hypoglycaemia * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Vitamin D deficiency * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Back pain * 1  0/198 (0.00%)  0 3/203 (1.48%)  3
Exostosis * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Myalgia * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Osteoarthritis * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Muscle tightness * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous cell carcinoma * 1  0/198 (0.00%)  0 1/203 (0.49%)  2
Nervous system disorders     
Burning sensation * 1  3/198 (1.52%)  3 0/203 (0.00%)  0
Headache * 1  9/198 (4.55%)  21 2/203 (0.99%)  3
Nerve compression * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Paraesthesia * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Sciatica * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Tension headache * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Psychiatric disorders     
Insomnia * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Reproductive system and breast disorders     
Ovarian cyst * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough * 1  2/198 (1.01%)  2 1/203 (0.49%)  1
Nasal congestion * 1  3/198 (1.52%)  3 2/203 (0.99%)  2
Sinus congestion * 1  1/198 (0.51%)  1 1/203 (0.49%)  1
Wheezing * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Nasal disorder * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Oropharyngeal pain * 1  2/198 (1.01%)  2 1/203 (0.49%)  1
Skin and subcutaneous tissue disorders     
Actinic keratosis * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Dermal cyst * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Dermatitis contact * 1  0/198 (0.00%)  0 1/203 (0.49%)  2
Dry skin * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Eczema asteatotic * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Erythema * 1  1/198 (0.51%)  1 1/203 (0.49%)  1
Pruritus * 1  4/198 (2.02%)  4 0/203 (0.00%)  0
Rash morbilliform * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Rosacea * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Skin lesion * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Telangiectasia * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
Urticaria * 1  1/198 (0.51%)  2 0/203 (0.00%)  0
Surgical and medical procedures     
Dental care * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Mammoplasty * 1  1/198 (0.51%)  1 0/203 (0.00%)  0
Vascular disorders     
Flushing * 1  0/198 (0.00%)  0 1/203 (0.49%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: Bayer HealthCare Pharmaceuticals, Inc. (formerly Intendis GmbH)
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01025635     History of Changes
Other Study ID Numbers: 14955
1403120 ( Other Identifier: Company internal )
First Submitted: November 26, 2009
First Posted: December 3, 2009
Results First Submitted: May 7, 2013
Results First Posted: July 1, 2013
Last Update Posted: May 5, 2014