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

Primary Purpose

Papulopustular Rosacea

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Azelaic acid foam, 15% (BAY39-6251)
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

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of papulopustular rosacea
  • Free of any clinically significant disease, which could interfere with the study
  • Male or female subject aged ≥ 18 years
  • Willingness of subject to follow all study procedures
  • Signed written informed consent before any study-related activities are carried out

Exclusion Criteria:

  • Subjects who are known to be non-responders to azelaic acid
  • Presence of dermatoses that might interfere with rosacea diagnosis
  • Ocular rosacea; phymatous rosacea; subjects with plaque-type rosacea lesions, papulopustular rosacea that requires systemic treatment
  • Topical use of any prescription or non-prescription medication to treat rosacea within 6 weeks prior to randomization and throughout the study
  • Systemic use of any prescription or non-prescription medication to treat rosacea (Retinoids within 6 months, Tetracycline within 2 months, Corticosteroids, erythromycin, azithromycin, and/or metronidazole within 4 weeks) prior to randomization and throughout the study
  • Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to randomization
  • Known hypersensitivity to any ingredients of the investigational product formulation
  • Participation in another clinical research in parallel or within the last 4 weeks before randomization in this study
  • Any condition or therapy that in the investigator's opinion may pose a risk to the subject or that could interfere with any evaluation in the 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

0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.

0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin 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)
Static evaluation of overall severity of papulopustular rosacea at a given time: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous 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 at End of Treatment (LOCF)
The mean (standard deviation) change from baseline in the inflammatory lesion count at the end of treatment is provided.

Secondary Outcome Measures

Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF)
The mean (standard deviation) percentage change in inflammatory lesion count from baseline to end of study is provided.
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF)
Participants achieving a clear, minimal, or mild IGA at the end of treatment were considered as 'responder'. Participants with an IGA of moderate or severe at the end of treatment were considered as 'non-responder'. Participants who prematurely withdraw from study treatment because of lack of efficacy were coded as 'non-responders'. The percentage of responders is presented.
Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF)
Erythema was rated as: clear or almost clear; mild; moderate; or severe. For the assessment of the grouped change in erythema ratings, the baseline examination was used to group into 'improved', 'no change', or 'worsened'. A participant was considered to have an 'improved' erythema rating if the erythema rating was lower compared to the baseline rating, 'no change' if the rating was identical, and 'worsened' if the rating was higher. The percentage of participants in each of these categories is presented.
Percentage of Participants With Investigator's Global Assessment (IGA) Scores at End of Treatment (LOCF)
The IGA consists of 5 scores: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. The percentage of participants with each score at the end of treatment is provided.
Nominal Value of Inflammatory Lesion Count at End of Treatment (LOCF)
The mean (standard deviation) lesion count at the end of treatment is provided.
Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF)
The percentage of participants in each rating category of erythema (clear or almost clear; mild; moderate; severe) at the end of treatment is provided.
Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF)
Telangiectasia was rated as: no; mild; moderate; or severe. At the end of study, a participant was considered to have an 'improved' telangiectasia rating if the telangiectasia rating was lower compared to the baseline rating, 'no change' if the rating was identical, and 'worsened' if the rating was higher. The percentage of participants in each category is presented.
Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF)
Facial skin color (as compared with skin outside the treatment area) was rated as: normal; barely visible skin lightening; mild skin lightening; moderate skin lightening; severe skin lightening. The percentage of participants in each category of facial skin color at the end of study is presented.
Participants' Global Assessment of Treatment Response at End of Treatment
At the end of treatment, participants assessed the change of papulopustular rosacea from baseline (how it looked, felt, appeared to others) as excellent improvement, good improvement, fair improvement, no improvement, or worse. The number of participants in each category of this assessment is presented.
Participants' Global Assessment of Tolerability at End of Treatment
At the end of treatment, participants provided their opinion on local tolerability of the investigational product as excellent, good, acceptable despite minor irritation, less acceptable due to continuous irritation, non-acceptable, or no opinion. The number of participants in each category of this assessment is presented.
Participants' Opinion on Cosmetic Acceptability at End of Treatment
At the end of treatment, participants provided their opinion on cosmetic acceptability of the investigational product as very good, good, satisfactory, poor, or no opinion. The number of participants in each category of this assessment is presented.
Participants' Opinion on Practicability of Product Use in Facial Areas Next to the Hairline at End of Treatment
At the end of treatment, participants provided their opinion on the practicability of the use of the investigational product in facial areas next to the hairline as very good, good, satisfactory, poor, or no opinion. The number of participants in each category of this assessment is presented.
Change From Baseline in Rosacea Quality of Life (RosaQoL) Questionnaire at End of Treatment - Overall Quality of Life Score
The Rosacea Quality of Life (RosaQoL) is a questionnaire to evaluate the effect of rosacea on a participant's quality of life. Each of the 21 items in this questionnaire asks about the frequency with which a particular aspect of living with rosacea affects the participant: possible responses for each item are "never" (score=1), "rarely" (score=2), "sometimes" (score=3), "often" (score=4), or "all the time" (score=5). The overall score is the sum of the results from all 21 questions, with possible scores ranging from 21 (best) to 105 (worst); the higher the score, the more quality of life is impaired. The mean (standard deviation) of the change, defined as end of treatment overall score minus baseline overall score, is presented.
Number of Participants With Change From Baseline in Dermatology Life Quality Index (DLQI) Questionnaire at End of Treatment - Overall Score
The Dermatology Life Quality Index (DLQI) is a questionnaire consisting of a set of 10 questions that evaluate the degree to which the participant's skin has affected certain behaviors and quality of life over the past week. Possible responses to each question are: "very much" (question 7: "yes") (score=3), "a lot" (score=2), "a little" (score=1), or "not at all"/"not relevant" (score=0). The DLQI overall score is the sum of the results from all 10 questions, with possible scores ranging from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The number of participants with score changes (end of treatment - baseline) in DLQI overall score from baseline to end of treatment <=-5 and >-5 are presented.
Change From Baseline in EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) at End of Treatment
The EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) is a standardized instrument for use as a measure of health outcome. The EQ-VAS asks for a judgment of the overall health status assessed by the participant her/himself. The 20-cm visual analog scale (VAS) has endpoints labeled "best imaginable health state" and "worst imaginable health state" that are anchored at 100 and 0, respectively. Respondents are asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS, which best represents their own health on that day; higher scores indicate a better health state. The median (range) of the change, defined as EQ-VAS at end of treatment minus EQ-VAS at baseline, is presented.
Change From Baseline in Index Value at End of Treatment
The EuroQol Group Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L) is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. It is used to assess the level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension is evaluated using 5 levels: "no problems" (level 1), "slight problems" (level 2), "moderate problems" (level 3), "severe problems" (level 4), and "extreme problems" (level 5). A scoring formula developed by EuroQol Group calculates a single index value from the results from all 5 domains along a continuum of 0 (death) to 1 (full health). The median (range) change, defined as the index value at end of treatment minus the index value at baseline, is presented.

Full Information

First Posted
March 13, 2012
Last Updated
June 8, 2023
Sponsor
LEO Pharma
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01555463
Brief Title
Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea
Official Title
A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-group Clinical Trial to Assess the Safety and Efficacy of Azelaic Acid Foam, 15% Topically Applied Twice Daily for 12 Weeks in Subjects With Papulopustular Rosacea
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and efficacy of azelaic acid (AzA) foam, 15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea compared to its vehicle.
Detailed Description
To determine the efficacy of AzA foam, 15% compared to vehicle topically applied twice daily in papulopustular rosacea evaluated by therapeutic success rate according to Investigators Global Assessment (IGA) and change in inflammatory lesion count from baseline to end of treatment. Evaluation of all adverse events will be covered in Adverse Events section.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papulopustular Rosacea
Keywords
Rosacea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
961 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azelaic acid foam, 15% (BAY39-6251)
Arm Type
Experimental
Arm Description
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
Arm Title
Vehicle foam
Arm Type
Placebo Comparator
Arm Description
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Azelaic acid foam, 15% (BAY39-6251)
Intervention Description
Azelaic acid twice daily topical application
Intervention Type
Drug
Intervention Name(s)
Vehicle foam
Intervention Description
twice daily topical application
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
Static evaluation of overall severity of papulopustular rosacea at a given time: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous 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 (LOCF), up to 12 weeks
Title
Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF)
Description
The mean (standard deviation) change from baseline in the inflammatory lesion count at the end of treatment is provided.
Time Frame
Baseline and end of treatment (LOCF), up to 12 weeks
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF)
Description
The mean (standard deviation) percentage change in inflammatory lesion count from baseline to end of study is provided.
Time Frame
Baseline and end of treatment (LOCF), up to 12 weeks
Title
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF)
Description
Participants achieving a clear, minimal, or mild IGA at the end of treatment were considered as 'responder'. Participants with an IGA of moderate or severe at the end of treatment were considered as 'non-responder'. Participants who prematurely withdraw from study treatment because of lack of efficacy were coded as 'non-responders'. The percentage of responders is presented.
Time Frame
At end of treatment (LOCF), up to 12 weeks
Title
Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF)
Description
Erythema was rated as: clear or almost clear; mild; moderate; or severe. For the assessment of the grouped change in erythema ratings, the baseline examination was used to group into 'improved', 'no change', or 'worsened'. A participant was considered to have an 'improved' erythema rating if the erythema rating was lower compared to the baseline rating, 'no change' if the rating was identical, and 'worsened' if the rating was higher. The percentage of participants in each of these categories is presented.
Time Frame
Baseline and end of treatment (LOCF), up to 12 weeks
Title
Percentage of Participants With Investigator's Global Assessment (IGA) Scores at End of Treatment (LOCF)
Description
The IGA consists of 5 scores: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. The percentage of participants with each score at the end of treatment is provided.
Time Frame
At end of treatment (LOCF), up to 12 weeks
Title
Nominal Value of Inflammatory Lesion Count at End of Treatment (LOCF)
Description
The mean (standard deviation) lesion count at the end of treatment is provided.
Time Frame
At end of treatment (LOCF), up to 12 weeks
Title
Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF)
Description
The percentage of participants in each rating category of erythema (clear or almost clear; mild; moderate; severe) at the end of treatment is provided.
Time Frame
At end of treatment (LOCF), up to 12 weeks
Title
Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF)
Description
Telangiectasia was rated as: no; mild; moderate; or severe. At the end of study, a participant was considered to have an 'improved' telangiectasia rating if the telangiectasia rating was lower compared to the baseline rating, 'no change' if the rating was identical, and 'worsened' if the rating was higher. The percentage of participants in each category is presented.
Time Frame
Baseline and end of treatment (LOCF), up to 12 weeks
Title
Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF)
Description
Facial skin color (as compared with skin outside the treatment area) was rated as: normal; barely visible skin lightening; mild skin lightening; moderate skin lightening; severe skin lightening. The percentage of participants in each category of facial skin color at the end of study is presented.
Time Frame
At end of treatment (LOCF), up to 12 weeks
Title
Participants' Global Assessment of Treatment Response at End of Treatment
Description
At the end of treatment, participants assessed the change of papulopustular rosacea from baseline (how it looked, felt, appeared to others) as excellent improvement, good improvement, fair improvement, no improvement, or worse. The number of participants in each category of this assessment is presented.
Time Frame
At end of treatment, up to 12 weeks
Title
Participants' Global Assessment of Tolerability at End of Treatment
Description
At the end of treatment, participants provided their opinion on local tolerability of the investigational product as excellent, good, acceptable despite minor irritation, less acceptable due to continuous irritation, non-acceptable, or no opinion. The number of participants in each category of this assessment is presented.
Time Frame
At end of treatment, up to 12 weeks
Title
Participants' Opinion on Cosmetic Acceptability at End of Treatment
Description
At the end of treatment, participants provided their opinion on cosmetic acceptability of the investigational product as very good, good, satisfactory, poor, or no opinion. The number of participants in each category of this assessment is presented.
Time Frame
At end of treatment, up to 12 weeks
Title
Participants' Opinion on Practicability of Product Use in Facial Areas Next to the Hairline at End of Treatment
Description
At the end of treatment, participants provided their opinion on the practicability of the use of the investigational product in facial areas next to the hairline as very good, good, satisfactory, poor, or no opinion. The number of participants in each category of this assessment is presented.
Time Frame
At end of treatment, up to 12 weeks
Title
Change From Baseline in Rosacea Quality of Life (RosaQoL) Questionnaire at End of Treatment - Overall Quality of Life Score
Description
The Rosacea Quality of Life (RosaQoL) is a questionnaire to evaluate the effect of rosacea on a participant's quality of life. Each of the 21 items in this questionnaire asks about the frequency with which a particular aspect of living with rosacea affects the participant: possible responses for each item are "never" (score=1), "rarely" (score=2), "sometimes" (score=3), "often" (score=4), or "all the time" (score=5). The overall score is the sum of the results from all 21 questions, with possible scores ranging from 21 (best) to 105 (worst); the higher the score, the more quality of life is impaired. The mean (standard deviation) of the change, defined as end of treatment overall score minus baseline overall score, is presented.
Time Frame
Baseline and end of treatment, up to 12 weeks
Title
Number of Participants With Change From Baseline in Dermatology Life Quality Index (DLQI) Questionnaire at End of Treatment - Overall Score
Description
The Dermatology Life Quality Index (DLQI) is a questionnaire consisting of a set of 10 questions that evaluate the degree to which the participant's skin has affected certain behaviors and quality of life over the past week. Possible responses to each question are: "very much" (question 7: "yes") (score=3), "a lot" (score=2), "a little" (score=1), or "not at all"/"not relevant" (score=0). The DLQI overall score is the sum of the results from all 10 questions, with possible scores ranging from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The number of participants with score changes (end of treatment - baseline) in DLQI overall score from baseline to end of treatment <=-5 and >-5 are presented.
Time Frame
Baseline and end of treatment, up to 12 weeks
Title
Change From Baseline in EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) at End of Treatment
Description
The EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) is a standardized instrument for use as a measure of health outcome. The EQ-VAS asks for a judgment of the overall health status assessed by the participant her/himself. The 20-cm visual analog scale (VAS) has endpoints labeled "best imaginable health state" and "worst imaginable health state" that are anchored at 100 and 0, respectively. Respondents are asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS, which best represents their own health on that day; higher scores indicate a better health state. The median (range) of the change, defined as EQ-VAS at end of treatment minus EQ-VAS at baseline, is presented.
Time Frame
Baseline and end of treatment, up to 12 weeks
Title
Change From Baseline in Index Value at End of Treatment
Description
The EuroQol Group Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L) is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. It is used to assess the level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension is evaluated using 5 levels: "no problems" (level 1), "slight problems" (level 2), "moderate problems" (level 3), "severe problems" (level 4), and "extreme problems" (level 5). A scoring formula developed by EuroQol Group calculates a single index value from the results from all 5 domains along a continuum of 0 (death) to 1 (full health). The median (range) change, defined as the index value at end of treatment minus the index value at baseline, is presented.
Time Frame
Baseline and end of treatment, up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of papulopustular rosacea Free of any clinically significant disease, which could interfere with the study Male or female subject aged ≥ 18 years Willingness of subject to follow all study procedures Signed written informed consent before any study-related activities are carried out Exclusion Criteria: Subjects who are known to be non-responders to azelaic acid Presence of dermatoses that might interfere with rosacea diagnosis Ocular rosacea; phymatous rosacea; subjects with plaque-type rosacea lesions, papulopustular rosacea that requires systemic treatment Topical use of any prescription or non-prescription medication to treat rosacea within 6 weeks prior to randomization and throughout the study Systemic use of any prescription or non-prescription medication to treat rosacea (Retinoids within 6 months, Tetracycline within 2 months, Corticosteroids, erythromycin, azithromycin, and/or metronidazole within 4 weeks) prior to randomization and throughout the study Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to randomization Known hypersensitivity to any ingredients of the investigational product formulation Participation in another clinical research in parallel or within the last 4 weeks before randomization in this study Any condition or therapy that in the investigator's opinion may pose a risk to the subject or that could interfere with any evaluation in the 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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0660
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80915
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472-2952
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
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
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
City
Buffalo Grove
State/Province
Illinois
ZIP/Postal Code
60089
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60625
Country
United States
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
Richmond
State/Province
Kentucky
ZIP/Postal Code
40475
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
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
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26244354
Citation
Draelos ZD, Elewski BE, Harper JC, Sand M, Staedtler G, Nkulikiyinka R, Shakery K. A phase 3 randomized, double-blind, vehicle-controlled trial of azelaic acid foam 15% in the treatment of papulopustular rosacea. Cutis. 2015 Jul;96(1):54-61.
Results Reference
result

Learn more about this trial

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

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