Papulopustular RosaceaPhase 4NCT00855595
Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea
A Phase 4 study testing Azelaic acid (Finacea, BAY39-6251), Metronidazole (Metrogel) and Doxycycline (Oracea) in people with Papulopustular Rosacea, run by LEO Pharma at 17 sites in United States.
Trial summary
Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus an anti-inflammatory dose of doxycyline (40mg) daily or with metronidazole 1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at total of twelve weeks to determine the… 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 (Finacea, BAY39-6251), Metronidazole (Metrogel) and Doxycycline (Oracea)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 17 sitesUnited States
- Study dates
- Feb 2009to Jul 2009
- Phase
- Phase 4
- 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
- Moderate papulopustular rosacea (IGA>4) with a minimum of 10 and no more than 50 inflammatory lesions and persistent erythema with or without telangiectasia
Who cannot join
- Sensitivity to any of the treatments used
- Co-existing conditions that would unfavorably influence the course of the disease
- Pregnant or lactating women
- Severe rosacea
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Study site
Albuquerque, New Mexico, 87106
Study site
Austin, Texas, 78759
Study site
Birmingham, Alabama, 35233
Study site
Boston, Massachusetts, 02114-2517
Study site
Dallas, Texas, 75246
Study site
Denver, Colorado, 80209
Study site
Fridley, Minnesota, 55432
Study site
Henderson, Nevada, 89052
Study site
Houston, Texas, 77056
Study site
Mason, Ohio, 45040
Study site
Norfolk, Virginia, 23507
Study site
Portland, Oregon, 97223
Study site
Salt Lake City, Utah, 84124
Study site
San Antonio, Texas, 78229
Study site
Stony Brook, New York, 11790
Study site
Warren, Michigan, 48088
Study site
West Palm Beach, Florida, 33401
About this study
Official title: An Exploratory, Multicenter, Investigator-blinded, Active-controlled Study to Investigate the Efficacy of Topical Azelaic Acid (AzA)15% Gel Twice Daily or Metronidazole Topical Gel 1% Once Daily, Plus Anti-inflammatory Dose Doxycycline (40mg) Once Daily in Subjects With Moderate Papulopustular Rosacea
Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus an anti-inflammatory dose of doxycyline (40mg) daily or with metronidazole 1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at total of twelve weeks to determine the rapidity of improvement, and the length of time to reach 25%, 50% and 75% clearing compared to baseline.
Read the detailed description
The change in inflammatory lesion count will be assessed at each post-baseline visit by an analysis of variance model (ANOVA) with factors treatment and center, but not including treatment-by-center interaction.
Investigator's Global Assessment (IGA) of papulopustular rosacea (static score): 0 - Clear (Virtually no rosacea ie, no papules and/or pustules; no or residual erythema; no or mild to moderate degree of telangiectasia may be present); 1 - Minimal (Rare papules and/or pustules; residual to mild erythema; mild to moderate degree of telangiectasia may be present); 2 - Mild (Few papules and/or pustules; mild erythema; mild to moderate degree of telangiectasia may be present); 3 - Mild to moderate (Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate degree of telangiectasia may be present); 4 - Moderate (Pronounced number of papules and/or pustules; moderate erythema; mild to moderate degree of telangiectasia may be present); 5 - Moderate to severe (Many papules and/or pustules, occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia may be present); 6 - Severe (Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe degree of telangiectasia may be present).
- Conditions
- Papulopustular Rosacea
- Being tested
- Azelaic acid (Finacea, BAY39-6251), Metronidazole (Metrogel), Doxycycline (Oracea)
- Keywords
- Rosacea
- 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 (Finacea, BAY39-6251)Drug
Participants received topical azelaic acid gel 15% twice daily for 12 weeks
Metronidazole (Metrogel)Drug
Participants received topical metronidazole 1% gel once daily for 12 weeks
Doxycycline (Oracea)Drug
Participants received systemic doxycycline 40 mg once daily for 12 week
| Study group | Role | What they receive |
|---|---|---|
| Azelaic acid (Finacea, BAY39-6251) plus Doxycycline (Oracea) | Experimental | Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks Receives: Drug: Azelaic acid (Finacea, BAY39-6251); Drug: Doxycycline (Oracea) |
| Metronidazole (Metrogel) plus Doxycycline (Oracea) | Active comparator | Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks Receives: Drug: Metronidazole (Metrogel); Drug: Doxycycline (Oracea) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)
NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
Measured: Baseline and Week 2
Secondary outcomes (14)
Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)
Measured: Week 2, 4, 6, 8 and 12
Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)
NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
Measured: Baseline and Week 4, 6, 8 and 12
Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)
NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
Measured: Baseline and Week 2, 4, 6, 8 and 12
Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)
Measured: Baseline and Weeks 2, 4, 6, 8 and 12
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Therapeutic success is defined as an IGA score of clear or minimal (0 or 1).
Measured: Weeks 2, 4, 6, 8 and 12
Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Patient response is defined as an IGA score of clear, minimal, or mild (0, 1, or 2)
Measured: Weeks 2, 4, 6, 8 and 12
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).
Measured: At Week 2
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).
Measured: At Week 4
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).
Measured: At Week 6
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).
Measured: At Week 8
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12
IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).
Measured: At Week 12
Investigator Rating of Overall Improvement at End of Study (Week 12)
Measured: Week 12
Patient Rating of Overall Improvement at End of Study (Week 12)
Measured: Week 12
Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2009
- Study completionJul 2009
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 207 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
- NCT00855595
- Sponsor's protocol ID
- 14366
- Other IDs
- 1402604, 256-0024
- Status last verified
- Jan 2014
- First submitted
- 3 Mar 2009
- Last updated
- 31 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Del Rosso JQ, Bruce S, Jarratt M, Menter A, Staedtler G. Efficacy of topical azelaic acid (AzA) gel 15% plus oral doxycycline 40 mg versus metronidazole gel 1% plus oral doxycycline 40 mg in mild-to-moderate papulopustular rosacea. J Drugs Dermatol. 2010 Jun;9(6):607-13.
PubMed 20645521
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
- An Exploratory, Multicenter, Investigator-blinded, Active-controlled Study to Investigate the Efficacy of Topical Azelaic Acid (AzA)15% Gel Twice Daily or Metronidazole Topical Gel 1% Once Daily, Plus Anti-inflammatory Dose Doxycycline (40mg) Once Daily in Subjects With Moderate Papulopustular Rosacea
- ClinicalTrials.gov ID
- NCT00855595
- Acronym / sponsor ID
- 14366
- Conditions
- Papulopustular Rosacea
- Keywords
- Rosacea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- Feb 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 4 Mar 2009 (estimated)
- Results
- Posted 29 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus an anti-inflammatory dose of doxycyline (40mg) daily or with metronidazole 1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at total of twelve weeks to determine the rapidity of improvement, and the length of time to reach 25%, 50% and 75% clearing compared to baseline.
Detailed description
The change in inflammatory lesion count will be assessed at each post-baseline visit by an analysis of variance model (ANOVA) with factors treatment and center, but not including treatment-by-center interaction.
Investigator's Global Assessment (IGA) of papulopustular rosacea (static score): 0 - Clear (Virtually no rosacea ie, no papules and/or pustules; no or residual erythema; no or mild to moderate degree of telangiectasia may be present); 1 - Minimal (Rare papules and/or pustules; residual to mild erythema; mild to moderate degree of telangiectasia may be present); 2 - Mild (Few papules and/or pustules; mild erythema; mild to moderate degree of telangiectasia may be present); 3 - Mild to moderate (Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate degree of telangiectasia may be present); 4 - Moderate (Pronounced number of papules and/or pustules; moderate erythema; mild to moderate degree of telangiectasia may be present); 5 - Moderate to severe (Many papules and/or pustules, occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia may be present); 6 - Severe (Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe degree of telangiectasia may be present).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azelaic acid (Finacea, BAY39-6251) plus Doxycycline (Oracea) | Experimental | Drug: Azelaic acid (Finacea, BAY39-6251), Drug: Doxycycline (Oracea)Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks |
| Metronidazole (Metrogel) plus Doxycycline (Oracea) | Active comparator | Drug: Metronidazole (Metrogel), Drug: Doxycycline (Oracea)Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once 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 (1 listed)
- Moderate papulopustular rosacea (IGA>4) with a minimum of 10 and no more than 50 inflammatory lesions and persistent erythema with or without telangiectasia
Key exclusion criteria (4 listed)
- Sensitivity to any of the treatments used
- Co-existing conditions that would unfavorably influence the course of the disease
- Pregnant or lactating women
- Severe rosacea
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 (Finacea, BAY39-6251)Participants received topical azelaic acid gel 15% twice daily for 12 weeks | Drug | Azelaic acid (Finacea, BAY39-6251) plus Doxycycline (Oracea) |
| Metronidazole (Metrogel)Participants received topical metronidazole 1% gel once daily for 12 weeks | Drug | Metronidazole (Metrogel) plus Doxycycline (Oracea) |
| Doxycycline (Oracea)Participants received systemic doxycycline 40 mg once daily for 12 week | Drug | Azelaic acid (Finacea, BAY39-6251) plus Doxycycline (Oracea), Metronidazole (Metrogel) plus Doxycycline (Oracea) |
Primary outcome
Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)
Time frame: Baseline and Week 2
NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
14 secondary outcomes
Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)
Time frame: Week 2, 4, 6, 8 and 12
Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)
Time frame: Baseline and Week 4, 6, 8 and 12
Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)
Time frame: Baseline and Week 2, 4, 6, 8 and 12
Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)
Time frame: Baseline and Weeks 2, 4, 6, 8 and 12
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)
Time frame: Weeks 2, 4, 6, 8 and 12
Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)
Time frame: Weeks 2, 4, 6, 8 and 12
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2
Time frame: At Week 2
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4
Time frame: At Week 4
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6
Time frame: At Week 6
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8
Time frame: At Week 8
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12
Time frame: At Week 12
Investigator Rating of Overall Improvement at End of Study (Week 12)
Time frame: Week 12
Patient Rating of Overall Improvement at End of Study (Week 12)
Time frame: Week 12
Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)
Time frame: Week 12
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.
- Results publication: PubMed 20645521Del Rosso JQ, Bruce S, Jarratt M, Menter A, Staedtler G. Efficacy of topical azelaic acid (AzA) gel 15% plus oral doxycycline 40 mg versus metronidazole gel 1% plus oral doxycycline 40 mg in mild-to-moderate papulopustular rosacea. J Drugs Dermatol. 2010 Jun;9(6):607-13.
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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
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azelaic acid (Finacea, BAY39-6251), Metronidazole (Metrogel) and Doxycycline (Oracea) in people with Papulopustular Rosacea, run by LEO Pharma at 17 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 1 inclusion and 4 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 17 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 29 Aug 2012). 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?
Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward) (time frame: Baseline and Week 2). 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 NCT00855595, 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.