Papulopustular RosaceaPhase 2NCT01025635
Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea
A Phase 2 study testing Azelaic acid foam 15% in people with Papulopustular Rosacea, run by LEO Pharma at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papulopustular Rosacea
- What is being tested?
- Azelaic acid foam 15%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 401 participants
- Where
- 20 sitesUnited States
- Study dates
- Dec 2009to Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Study site
Albuquerque, New Mexico, 87106
Study site
Austin, Texas, 78759
Study site
Birmingham, Alabama, 35209
Study site
Birmingham, Alabama, 35233
Study site
Fremont, California, 94538
Study site
High Point, North Carolina, 27262
Study site
Johnston, Rhode Island, 02919
Study site
Knoxville, Tennessee, 37922
Study site
Madison, Wisconsin, 53719
Study site
Miami, Florida, 33175
Study site
Miramar, Florida, 33027
Study site
Nashville, Tennessee, 37215
Study site
Omaha, Nebraska, 68144
Study site
Plano, Texas, 75093
Study site
Portland, Oregon, 97210
Study site
Salt Lake City, Utah, 84124
Study site
Santa Monica, California, 90404
Study site
Simpsonville, South Carolina, 29681
Study site
Wilmington, North Carolina, 28401
Study site
Winston-Salem, North Carolina, 27103
About this study
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
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.
- Conditions
- Papulopustular Rosacea
- Being tested
- Azelaic acid foam 15%, Vehicle foam
- Keywords
- rosacea, papulopustular, azelaic acid, foam
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azelaic acid foam 15%Drug
Applied topically twice daily for 12 weeks
Vehicle foamDrug
Applied topically twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Azelaic acid foam, 15% (BAY39-6251) | Experimental | Participants received azelaic acid foam, 15% topically twice daily for 12 weeks Receives: Drug: Azelaic acid foam 15% |
| Vehicle foam | Placebo comparator | Participants received vehicle foam topically twice daily for 12 weeks Receives: Drug: Vehicle foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At End of treatment (up to 12 weeks) (LOCF)
Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)
Measured: Baseline and End of treatment (up to 12 weeks) (LOCF)
Secondary outcomes (2)
Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)
Measured: At End of treatment (up to 12 weeks) (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'.
Measured: At End of treatment (up to 12 weeks) (LOCF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Papulopustular RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025635
- Sponsor's protocol ID
- 14955
- Other IDs
- 1403120
- Status last verified
- Apr 2014
- First submitted
- 26 Nov 2009
- Last updated
- 31 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24416747
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01025635
- Acronym / sponsor ID
- 14955
- Conditions
- Papulopustular Rosacea
- Keywords
- rosacea, papulopustular, azelaic acid, foam
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- Dec 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 3 Dec 2009 (estimated)
- Results
- Posted 1 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azelaic acid foam, 15% (BAY39-6251) | Experimental | Drug: Azelaic acid foam 15%Participants received azelaic acid foam, 15% topically twice daily for 12 weeks |
| Vehicle foam | Placebo comparator | Drug: Vehicle foamParticipants received vehicle foam topically twice daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azelaic acid foam 15%Applied topically twice daily for 12 weeks | Drug | Azelaic acid foam, 15% (BAY39-6251) |
| Vehicle foamApplied topically twice daily for 12 weeks | Drug | Vehicle foam |
Primary outcome
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)
Time frame: At End of treatment (up to 12 weeks) (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. 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)
Time frame: Baseline and End of treatment (up to 12 weeks) (LOCF)
2 secondary outcomes
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)
Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF)
Time frame: At End of treatment (up to 12 weeks) (LOCF)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24416747Draelos 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.
Related trials for Papulopustular Rosacea
RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Recruiting
Rosacea Radiofrequency Microneedling
Rosacea, Papulopustular, Rosacea, Erythematotelangiectatic
RecruitingPhase 2
Efficacy and Safety of Topical Clascoterone (WINLEVI) Cream 1% in Patients With Facial Acneiform Rosacea
Papular-pustular Rosacea, Papulopustular Rosacea (PPR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azelaic acid foam 15% in people with Papulopustular Rosacea, run by LEO Pharma at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward) (time frame: At End of treatment (up to 12 weeks) (LOCF)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01025635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.