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

Primary Purpose

Papulopustular Rosacea

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Azelaic acid foam 15%
Vehicle foam
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Papulopustular Rosacea focused on measuring rosacea, papulopustular, azelaic acid, foam

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed written informed consent
  • Diagnosis of papulopustular rosacea (IGA score of moderate or severe) with a minimum of 12 and maximum of 50 inflammatory lesions (papules and/or pustules) and persistent erythema with or without telangiectasia
  • Free of any clinically significant disease which could interfere with the study
  • Willingness to follow all study procedures
  • Male or female patient at least 18 years of age

Exclusion Criteria:

  • Subjects known to be non-responders to azelaic acid
  • Presence of dermatoses that might interfere with the rosacea diagnosis or the evaluation of treatment results
  • Ocular rosacea, phymatous rosacea
  • Any condition or therapy that in the opinion of the investigator may pose a risk to the patient of interfere with any evaluation in the study
  • Facial laser surgery in the 6 weeks prior to the study
  • Topical or systemic use of prescription or non-prescription medications to treat rosacea
  • Use of any agent other than the investigational drugs to treat rosacea during the study
  • Expected use or change in dose in the 90 days prior to the study of beta-blockers, vasodilators, NSAIDs, hormonal treatment or drugs causing acneiform eruptions
  • Known hypersensitivity to any ingredients of the investigational product formulation
  • Alcohol or drug abuse
  • Incapability of giving fully informed consent
  • Subject is dependent person, i.e., a relative/family member of the investigator and/or is a member of the investigator's staff
  • Participation in another clinical research study within the last 4 weeks before randomization in this study

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Azelaic acid foam, 15% (BAY39-6251)

Vehicle foam

Arm Description

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

Participants received vehicle foam topically twice daily for 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)
Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (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'.

Full Information

First Posted
November 26, 2009
Last Updated
March 30, 2020
Sponsor
LEO Pharma
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01025635
Brief Title
Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea
Official Title
Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-group Study to Investigate Safety and Efficacy of Azelaic Acid Foam, 15% Topically Applied Twice Daily in Subjects With Papulopustular Rosacea
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papulopustular Rosacea
Keywords
rosacea, papulopustular, azelaic acid, foam

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
401 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azelaic acid foam, 15% (BAY39-6251)
Arm Type
Experimental
Arm Description
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
Arm Title
Vehicle foam
Arm Type
Placebo Comparator
Arm Description
Participants received vehicle foam topically twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Azelaic acid foam 15%
Intervention Description
Applied topically twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle foam
Intervention Description
Applied topically twice daily for 12 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)
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)
Title
Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)
Time Frame
Baseline and End of treatment (up to 12 weeks) (LOCF)
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)
Time Frame
At End of treatment (up to 12 weeks) (LOCF)
Title
Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed written informed consent Diagnosis of papulopustular rosacea (IGA score of moderate or severe) with a minimum of 12 and maximum of 50 inflammatory lesions (papules and/or pustules) and persistent erythema with or without telangiectasia Free of any clinically significant disease which could interfere with the study Willingness to follow all study procedures Male or female patient at least 18 years of age Exclusion Criteria: Subjects known to be non-responders to azelaic acid Presence of dermatoses that might interfere with the rosacea diagnosis or the evaluation of treatment results Ocular rosacea, phymatous rosacea Any condition or therapy that in the opinion of the investigator may pose a risk to the patient of interfere with any evaluation in the study Facial laser surgery in the 6 weeks prior to the study Topical or systemic use of prescription or non-prescription medications to treat rosacea Use of any agent other than the investigational drugs to treat rosacea during the study Expected use or change in dose in the 90 days prior to the study of beta-blockers, vasodilators, NSAIDs, hormonal treatment or drugs causing acneiform eruptions Known hypersensitivity to any ingredients of the investigational product formulation Alcohol or drug abuse Incapability of giving fully informed consent Subject is dependent person, i.e., a relative/family member of the investigator and/or is a member of the investigator's staff Participation in another clinical research study within the last 4 weeks before randomization in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24416747
Citation
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 Reference
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Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea

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