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

March 30, 2020 updated by: LEO Pharma

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80209
    • Kansas
      • Olathe, Kansas, United States, 66062
    • Nevada
      • Henderson, Nevada, United States, 89052
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • Ohio
      • Mason, Ohio, United States, 45040
    • Texas
      • Austin, Texas, United States, 78759
    • Virginia
      • Norfolk, Virginia, United States, 23507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Baseline and End of Study (Week 12)
Baseline and End of Study (Week 12)
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF)
Time Frame: 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).
At End of Study (Week 12)
Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)
Time Frame: Baseline and End of Study (Week 12)
Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Baseline and End of Study (Week 12)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
Time Frame: 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
Time Frame: Baseline and 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)
Time Frame: Baseline and 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)
Time Frame: 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).
At Weeks 4, 8, 12 and End of Study (LOCF)
Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Time Frame: 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).
Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Time Frame: At Weeks 4, 8, 12 and End of Study (LOCF)
Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
At Weeks 4, 8, 12 and End of Study (LOCF)
Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Time Frame: 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
Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12
Time Frame: Baseline and Weeks 4, 8 and 12
Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Baseline and Weeks 4, 8 and 12
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Time Frame: At Weeks 4, 8, 12 and End of Study (LOCF)
Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
At Weeks 4, 8, 12 and End of Study (LOCF)
Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Time Frame: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Time Frame: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
Investigator's Rating of Overall Improvement at End of Study
Time Frame: 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
At End of Study (Week 12)
Patients' Rating of Overall Improvement at End of Study
Time Frame: At End of Study (Week 12)
Patient's rating of overall improvement: 1 - excellent; 2 - good; 3 - fair; 4 - no improvement; 5 - worse
At End of Study (Week 12)
Patients' Opinion on Cosmetic Acceptability at End of Study
Time Frame: At End of Study (Week 12)
Patient's opinion on cosmetic acceptability: 1 - very good; 2 - good; 3 - satisfactory; 4 - poor; 5 - no opinion
At End of Study (Week 12)
Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12
Time Frame: 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).").
At Weeks 4, 8 and 12
Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)
Time Frame: 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).
At Weeks 4, 8, 12 and End of Study (LOCF)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LEO Pharma

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1402140

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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