Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea

Sponsor

LEO Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00617903

Collaborator

Bayer (Industry)

Enrollment

Locations

Arms

Duration (Months)

11.9

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.

Condition or Disease	Intervention/Treatment	Phase
Papulopustular Rosacea	Drug: Azelaic acid Drug: Vehicle foam	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

83 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A 12-week Exploratory, Multicenter, Double-blind, Vehicle-controlled Study to Investigate the Efficacy and Safety of Topical Azelaic Acid 15% Foam Twice Daily in Patients With Papulopustular Rosacea

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Azelaic acid foam, 15% (BAY39-6251) Participants received azelaic acid foam, 15% topically twice daily for 12 weeks	Drug: Azelaic acid 15% foam to be applied topically twice daily
Placebo Comparator: Vehicle foam Participants received vehicle foam topically twice daily for 12 weeks	Drug: Vehicle foam Active-ingredient-free vehicle to be applied topically twice daily

Arm

Intervention/Treatment

Experimental: Azelaic acid foam, 15% (BAY39-6251)

Participants received azelaic acid foam, 15% topically twice daily for 12 weeks

Drug: Azelaic acid

15% foam to be applied topically twice daily

Placebo Comparator: Vehicle foam

Participants received vehicle foam topically twice daily for 12 weeks

Drug: Vehicle foam

Active-ingredient-free vehicle to be applied topically twice daily

Outcome Measures

Primary Outcome Measures

Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward) [Baseline and End of Study (Week 12)]
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF) [At End of Study (Week 12)]
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).
Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) [Baseline and End of Study (Week 12)]
Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe

Secondary Outcome Measures

Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) [At Weeks 4, 8, 12 and End of Study (LOCF)]
Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12 [Baseline and Weeks 4, 8 and 12]
Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) [Baseline and Weeks 4, 8, 12 and End of Study (LOCF)]
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) [At Weeks 4, 8, 12 and End of Study (LOCF)]
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).
Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) [Baseline and Weeks 4, 8, 12 and End of Study (LOCF)]
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) [At Weeks 4, 8, 12 and End of Study (LOCF)]
Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) [Baseline and Weeks 4, 8, 12 and End of Study (LOCF)]
Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 [Baseline and Weeks 4, 8 and 12]
Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) [At Weeks 4, 8, 12 and End of Study (LOCF)]
Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) [Baseline and Weeks 4, 8, 12 and End of Study (LOCF)]
Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) [Baseline and Weeks 4, 8, 12 and End of Study (LOCF)]
Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Investigator's Rating of Overall Improvement at End of Study [At End of Study (Week 12)]
Investigator's rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 - deterioration
Patients' Rating of Overall Improvement at End of Study [At End of Study (Week 12)]
Patient's rating of overall improvement: 1 - excellent; 2 - good; 3 - fair; 4 - no improvement; 5 - worse
Patients' Opinion on Cosmetic Acceptability at End of Study [At End of Study (Week 12)]
Patient's opinion on cosmetic acceptability: 1 - very good; 2 - good; 3 - satisfactory; 4 - poor; 5 - no opinion
Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12 [At Weeks 4, 8 and 12]
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success was defined as an IGA score of clear or minimal (0 to 1).").
Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF) [At Weeks 4, 8, 12 and End of Study (LOCF)]
IGA based Patient response was defined as an IGA score of clear, minimal or mild (0, 1, 2).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

male and female patient at least 18 years of age
signed informed consent
Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules and/or pustules, persistent erythema, and telangiectasia
Ability and willingness to accept and comply with treatment and required medical examinations

Exclusion Criteria:

Known non-responders to azelaic acid
Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea
Presence of dermatoses that could interfere with the rosacea diagnosis
Treatment with isotretinoin in the six months prior to randomization
Treatment of the face with topical retinoids during the two weeks prior to randomization
Treatment with oral antibiotics during the four weeks prior to randomization
Treatment with topical antibiotics
Treatment with systemic corticosteroids during 4 weeks prior to randomization
Treatment of the face with topical corticosteroids during 2 weeks prior to randomization
Treatment of the face with topical imidazole antimycotics during 2 weeks prior to randomization
Treatment of the face with topical azelaic acid formulations during 2 weeks prior to randomization
Use of a sauna during 2 weeks prior to randomization and during the study
Facial laser surgery for telangiectasia during 6 weeks prior to randomization
Planned concurrent use of any treatment other than study medication that affects rosacea
History of hypersensitivity to propylene glycol or any other ingredient of the study drugs
Participation in another clinical trial during the last 4 weeks

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Denver	Colorado	United States	80209
2	Olathe	Kansas	United States	66062
3	Henderson	Nevada	United States	89052
4	Albuquerque	New Mexico	United States	87106
5	Mason	Ohio	United States	45040
6	Austin	Texas	United States	78759
7	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

LEO Pharma
Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

LEO Pharma

ClinicalTrials.gov Identifier:

NCT00617903

Other Study ID Numbers:

1402140

First Posted:

Feb 18, 2008

Last Update Posted:

Apr 7, 2020

Last Verified:

Dec 1, 2013

Keywords provided by LEO Pharma

Additional relevant MeSH terms:

Rosacea

Azelaic acid

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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	41	42
COMPLETED	38	35
NOT COMPLETED	3	7

Baseline Characteristics

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam	Total
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 Participants	41	42	83
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	49.4 (11.9)	51.5 (12.5)	50.5 (12.2)
Sex: Female, Male (Count of Participants)
Female	25 61%	23 54.8%	48 57.8%
Male	16 39%	19 45.2%	35 42.2%
Previous duration of rosacea (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	88.5 (63.8)	91.9 (77.0)	90.2 (70.4)
Investigator's Global Assessment (IGA) score at Baseline (Scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Scores on a scale]	4.0 (0.9)	3.9 (0.9)	3.9 (0.9)
Number of inflammatory lesions per participant at Baseline (Inflammatory lesions) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Inflammatory lesions]	18.0 (10.61)	17.6 (8.36)	17.8 (9.48)
Erythema intensity score at baseline (Scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Scores on a scale]	3.1 (0.5)	3.0 (0.5)	3.0 (0.5)

Outcome Measures

1. Primary Outcome

Title	Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward)
Description
Time Frame	Baseline and End of Study (Week 12)

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	41	42
Mean (Standard Deviation) [Inflammatory lesions]	-11.7 (8.53)	-10.8 (7.80)

2. Primary Outcome

Title	Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF)
Description	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).
Time Frame	At End of Study (Week 12)

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	41	42
Number [Percentage of participants]	46.3 112.9%	47.6 113.3%

3. Primary Outcome

Title	Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)
Description	Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Time Frame	Baseline and End of Study (Week 12)

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	41	42
Improved	61.0 148.8%	47.6 113.3%
No change	36.6 89.3%	45.2 107.6%
Worse	2.4 5.9%	7.1 16.9%

4. Secondary Outcome

Title	Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
Description
Time Frame	At Weeks 4, 8, 12 and End of Study (LOCF)

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	41	42
Week 4	9.1 (7.93)	11.7 (9.23)
Week 8	6.8 (7.59)	6.6 (5.57)
Week 12	4.3 (5.86)	4.6 (5.47)
End of Study	6.3 (10.64)	6.8 (8.46)

5. Secondary Outcome

Title	Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12
Description
Time Frame	Baseline and Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	41	42
Week 4	-7.5 (4.68)	-5.8 (4.95)
Week 8	-9.9 (5.88)	-10.3 (6.62)
Week 12	-12.4 (8.38)	-12.4 (7.26)

6. Secondary Outcome

Title	Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
Description
Time Frame	Baseline and Weeks 4, 8, 12 and End of Study (LOCF)

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	41	42
Week 4	-49.5 (23.68)	-37.7 (36.70)
Week 8	-62.7 (29.82)	-62.8 (27.71)
Week 12	-75.1 (33.80)	-74.8 (32.40)
End of Study	-71.2 (36.42)	-65.3 (40.11)

7. Secondary Outcome

Title	Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Description	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).
Time Frame	At Weeks 4, 8, 12 and End of Study (LOCF)

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	41	42
Week 4-clear	0 0%	2.6 6.2%
Week 4-minimal	20.5 50%	10.5 25%
Week 4-mild	17.9 43.7%	21.1 50.2%
Week 4-mild to moderate	23.1 56.3%	21.1 50.2%
Week 4-moderate	30.8 75.1%	26.3 62.6%
Week 4-moderate to severe	7.7 18.8%	13.2 31.4%
Week 4-severe	0 0%	5.3 12.6%
Week 8-clear	7.9 19.3%	8.1 19.3%
Week 8-minimal	28.9 70.5%	27.0 64.3%
Week 8-mild	18.4 44.9%	16.2 38.6%
Week 8-mild to moderate	21.1 51.5%	16.2 38.6%
Week 8-moderate	15.8 38.5%	21.6 51.4%
Week 8-moderate to severe	7.9 19.3%	8.1 19.3%
Week 8-severe	0 0%	2.7 6.4%
Week 12-clear	10.5 25.6%	17.1 40.7%
Week 12-minimal	36.8 89.8%	37.1 88.3%
Week 12-mild	26.3 64.1%	8.6 20.5%
Week 12-mild to moderate	21.1 51.5%	20.0 47.6%
Week 12-moderate	0 0%	8.6 20.5%
Week 12-moderate to severe	5.3 12.9%	8.6 20.5%
Week 12-severe	0 0%	0 0%
End of Study-clear	9.8 23.9%	16.7 39.8%
End of Study-minimal	36.6 89.3%	31.0 73.8%
End of Study-mild	24.4 59.5%	7.1 16.9%
End of Study-mild to moderate	19.5 47.6%	19.0 45.2%
End of Study-moderate	0 0%	11.9 28.3%
End of Study-moderate to severe	7.3 17.8%	14.3 34%
End of Study-severe	2.4 5.9%	0 0%

8. Secondary Outcome

Title	Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Description	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).
Time Frame	Baseline and Weeks 4, 8, 12 and End of Study (LOCF)

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	41	42
Week 4	-1.0 (1.2)	-0.7 (1.1)
Week 8	-1.6 (1.3)	-1.3 (1.4)
Week 12	-2.1 (1.2)	-1.9 (1.3)
End of Study	-2.0 (1.3)	-1.7 (1.4)

9. Secondary Outcome

Title	Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Description	Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Time Frame	At Weeks 4, 8, 12 and End of Study (LOCF)

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	41	42
Week 4-clear or almost clear	5.1 12.4%	0 0%
Week 4-mild	30.8 75.1%	42.1 100.2%
Week 4-moderate	51.3 125.1%	50.0 119%
Week 4-severe	12.8 31.2%	7.9 18.8%
Week 8-clear or almost clear	13.2 32.2%	10.8 25.7%
Week 8-mild	36.8 89.8%	32.4 77.1%
Week 8-moderate	42.1 102.7%	45.9 109.3%
Week 8-severe	7.9 19.3%	10.8 25.7%
Week 12-clear or almost clear	18.4 44.9%	25.7 61.2%
Week 12-mild	42.1 102.7%	22.9 54.5%
Week 12-moderate	34.2 83.4%	45.7 108.8%
Week 12-severe	5.3 12.9%	5.7 13.6%
End of Study-clear or almost clear	17.1 41.7%	21.4 51%
End of Study-mild	41.5 101.2%	21.4 51%
End of Study-moderate	34.1 83.2%	52.4 124.8%
End of Study-severe	7.3 17.8%	4.8 11.4%

10. Secondary Outcome

Title	Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Description	Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Time Frame	Baseline and Weeks 4, 8, 12 and End of Study (LOCF)

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	41	42
Week 4	-0.3 (0.6)	-0.4 (0.6)
Week 8	-0.6 (0.7)	-0.5 (0.8)
Week 12	-0.8 (0.8)	-0.7 (1.0)
End of Study	-0.8 (0.8)	-0.6 (0.9)

11. Secondary Outcome

Title	Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12
Description	Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Time Frame	Baseline and Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	41	42
Week 4-Improved	35.9 87.6%	42.1 100.2%
Week 4-No change	59.0 143.9%	52.6 125.2%
Week 4-Worse	5.1 12.4%	5.3 12.6%
Week 8-Improved	50.0 122%	48.6 115.7%
Week 8-No change	50.0 122%	40.5 96.4%
Week 8-Worse	0 0%	10.8 25.7%
Week 12-Improved	63.2 154.1%	54.3 129.3%
Week 12-No change	34.2 83.4%	37.1 88.3%
Week 12-Worse	2.6 6.3%	8.6 20.5%

12. Secondary Outcome

Title	Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Description	Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Time Frame	At Weeks 4, 8, 12 and End of Study (LOCF)

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	41	42
Week 4-none	0 0%	2.6 6.2%
Week 4-mild	35.9 87.6%	42.1 100.2%
Week 4-moderate	64.1 156.3%	55.3 131.7%
Week 4-severe	0 0%	0 0%
Week 8-none	0 0%	5.4 12.9%
Week 8-mild	42.1 102.7%	56.8 135.2%
Week 8-moderate	57.9 141.2%	37.8 90%
Week 8-severe	0 0%	0 0%
Week 12-none	2.6 6.3%	2.9 6.9%
Week 12-mild	42.1 102.7%	62.9 149.8%
Week 12-moderate	55.3 134.9%	34.3 81.7%
Week 12-severe	0 0%	0 0%
End of Study-none	2.4 5.9%	2.4 5.7%
End of Study-mild	41.5 101.2%	59.5 141.7%
End of Study-moderate	56.1 136.8%	38.1 90.7%
End of Study-severe	0 0%	0 0%

13. Secondary Outcome

Title	Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Description	Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Time Frame	Baseline and Weeks 4, 8, 12 and End of Study (LOCF)

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	41	42
Week 4	0.0 (0.3)	-0.1 (0.4)
Week 8	-0.1 (0.3)	-0.3 (0.5)
Week 12	-0.2 (0.4)	-0.3 (0.5)
End of Study	-0.1 (0.4)	-0.2 (0.4)

14. Secondary Outcome

Title	Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Description	Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Time Frame	Baseline and Weeks 4, 8, 12 and End of Study (LOCF)

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	41	42
Week 4-Improved	5.1 12.4%	10.5 25%
Week 4-No change	92.3 225.1%	86.8 206.7%
Week 4-Worse	2.6 6.3%	2.6 6.2%
Week 8-Improved	10.5 25.6%	27.0 64.3%
Week 8-No change	89.5 218.3%	73.0 173.8%
Week 8-Worse	0 0%	0 0%
Week 12-Improved	15.8 38.5%	28.6 68.1%
Week 12-No change	84.2 205.4%	71.4 170%
Week 12-Worse	0 0%	0 0%
End of Study-Improved	14.6 35.6%	23.8 56.7%
End of Study-No change	85.4 208.3%	76.2 181.4%
End of Study-Worse	0 0%	0 0%

15. Secondary Outcome

Title	Investigator's Rating of Overall Improvement at End of Study
Description	Investigator's rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 - deterioration
Time Frame	At End of Study (Week 12)

Outcome Measure Data

Analysis Population Description
All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases)

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	38	40
Excellent Improvement	34.2 83.4%	40.0 95.2%
Marked Improvement	23.7 57.8%	17.5 41.7%
Moderate Improvement	31.6 77.1%	27.5 65.5%
No Improvement	7.9 19.3%	12.5 29.8%
Deterioration	2.6 6.3%	2.5 6%

16. Secondary Outcome

Title	Patients' Rating of Overall Improvement at End of Study
Description	Patient's rating of overall improvement: 1 - excellent; 2 - good; 3 - fair; 4 - no improvement; 5 - worse
Time Frame	At End of Study (Week 12)

Outcome Measure Data

Analysis Population Description
All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	38	40
Excellent Improvement	36.8 89.8%	27.5 65.5%
Good Improvement	28.9 70.5%	22.5 53.6%
Fair Improvement	21.1 51.5%	22.5 53.6%
No Improvement	5.3 12.9%	20.0 47.6%
Worse	7.9 19.3%	7.5 17.9%

17. Secondary Outcome

Title	Patients' Opinion on Cosmetic Acceptability at End of Study
Description	Patient's opinion on cosmetic acceptability: 1 - very good; 2 - good; 3 - satisfactory; 4 - poor; 5 - no opinion
Time Frame	At End of Study (Week 12)

Outcome Measure Data

Analysis Population Description
All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	38	40
Very Good	42.1 102.7%	35.0 83.3%
Good	36.8 89.8%	37.5 89.3%
Satisfactory	10.5 25.6%	5.0 11.9%
Poor	5.3 12.9%	10.0 23.8%
No Opinion	5.3 12.9%	12.5 29.8%

18. Secondary Outcome

Title	Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12
Description	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success was defined as an IGA score of clear or minimal (0 to 1).").
Time Frame	At Weeks 4, 8 and 12

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	41	42
Week 4	20.5 50%	13.2 31.4%
Week 8	36.8 89.8%	35.1 83.6%
Week 12	47.4 115.6%	54.3 129.3%

19. Secondary Outcome

Title	Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)
Description	IGA based Patient response was defined as an IGA score of clear, minimal or mild (0, 1, 2).
Time Frame	At Weeks 4, 8, 12 and End of Study (LOCF)

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)	Vehicle Foam
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
Measure Participants	41	42
Week 4	38.5 93.9%	34.2 81.4%
Week 8	55.3 134.9%	51.4 122.4%
Week 12	73.7 179.8%	62.9 149.8%
End of Study	70.7 172.4%	54.8 130.5%

Adverse Events

	Azelaic Acid Foam, 15% (BAY39-6251)		Vehicle Foam
Time Frame
Adverse Event Reporting Description

Arm/Group Title	Azelaic Acid Foam, 15% (BAY39-6251)		Vehicle Foam
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
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Azelaic Acid Foam, 15% (BAY39-6251)		Vehicle Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	Azelaic Acid Foam, 15% (BAY39-6251)		Vehicle Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/41 (34.1%)		10/42 (23.8%)
Eye disorders
Conjunctivitis	1/41 (2.4%)	1	0/42 (0%)	0
Gastrointestinal disorders
Diarrhoea	0/41 (0%)	0	1/42 (2.4%)	1
General disorders
Administration site reaction	2/41 (4.9%)	2	0/42 (0%)	0
Application site irritation	4/41 (9.8%)	4	1/42 (2.4%)	1
Infections and infestations
Infection	1/41 (2.4%)	1	0/42 (0%)	0
Nasopharyngitis	2/41 (4.9%)	3	1/42 (2.4%)	1
Sinusitis	0/41 (0%)	0	1/42 (2.4%)	1
Upper respiratory tract infection	1/41 (2.4%)	1	0/42 (0%)	0
Urinary tract infection	2/41 (4.9%)	2	0/42 (0%)	0
Vaginitis bacterial	1/41 (2.4%)	1	0/42 (0%)	0
Injury, poisoning and procedural complications
Sunburn	1/41 (2.4%)	1	0/42 (0%)	0
Musculoskeletal and connective tissue disorders
Musculoskeletal pain	1/41 (2.4%)	1	0/42 (0%)	0
Nervous system disorders
Headache	0/41 (0%)	0	2/42 (4.8%)	4
Respiratory, thoracic and mediastinal disorders
Cough	1/41 (2.4%)	1	0/42 (0%)	0
Pharyngolaryngeal pain	1/41 (2.4%)	1	0/42 (0%)	0
Skin and subcutaneous tissue disorders
Acne	0/41 (0%)	0	1/42 (2.4%)	1
Dermatitis contact	0/41 (0%)	0	1/42 (2.4%)	1
Dry skin	0/41 (0%)	0	2/42 (4.8%)	2
Erythema	0/41 (0%)	0	1/42 (2.4%)	1
Pruritus	2/41 (4.9%)	2	1/42 (2.4%)	1
Rosacea	1/41 (2.4%)	1	1/42 (2.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A) Investigator shall provide Sponsor with intended publication 60 days upfront publication date, Sponsor has 30 d to comment, recommended changes shall not be unreasonably refused B) Sponsor has the right to ask Investigator to delay publication for a maximum of 90 days C) Investigative data will be pooled and published by Sponsor - no other publication without the consent of all parties prior to publication of the pooled data, or within 12 months after LPLV, whatever comes first

Results Point of Contact

Name/Title	Therapeutic Area Head
Organization	Bayer
Phone
Email	clinical-trials-contact@bayer.com

Responsible Party:

LEO Pharma

ClinicalTrials.gov Identifier:

NCT00617903

Other Study ID Numbers:

1402140

First Posted:

Feb 18, 2008

Last Update Posted:

Apr 7, 2020

Last Verified:

Dec 1, 2013

Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

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Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact