Papulopustular RosaceaPhase 4NCT00417937
A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily
A Phase 4 study testing azelaic acid 15% gel in people with Papulopustular Rosacea, run by LEO Pharma at 1 site in Germany.
Trial summary
To assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus twice daily in the treatment of patients with papulopustular rosacea. 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 15% gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Jun 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Papulopustular facial rosacea; minimum of 10, maximum of 50 inflamed papules and/or pustules
Who cannot join
- Mild or severe rosacea
- Rosacea with marked ocular manifestations
- Presence of dermatoses that could interfere with the rosacea diagnosis or evaluation of the study course
- Wash out period required for patients treated prior to study with topical retinoids, oral antibiotics, topical antibiotics, systemic and topical corticosteroids, topical imidazole, laser surgery for telangiectasia
- History of hypersensitivity to propylene glycol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-Blind Clinical Trial to Assess the Efficacy and Tolerability of Topical Azelaic Acid 15% Gel Once Daily Compared to Topical Azelaic Acid 15% gelTwice Daily in Subjects With Papulopustular Rosacea
To assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus twice daily in the treatment of patients with papulopustular rosacea.
Read the detailed description
To test the efficacy and safety of once vs twice daily application of azelaic acid 15% gel on papulopustular rosacea
- Conditions
- Papulopustular Rosacea
- Being tested
- azelaic acid 15% gel
- 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 15% gelDrug
15% gel, topically applied once daily for six weeks
azelaic acid 15% gelDrug
15% gel, topically applied twice daily for six weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Azelaic acid 15 % gel once daily Receives: Drug: azelaic acid 15% gel |
| 2 | Active comparator | Azelaic acid 15 gel twice daily Receives: Drug: azelaic acid 15% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's global assessment scored on a seven point scale
Measured: Measurements made during the course of treatment
Secondary outcomes (1)
Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy
Measured: Parameters measured during the course of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 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
- NCT00417937
- Sponsor's protocol ID
- 14428
- Other IDs
- 1401460
- Status last verified
- Feb 2014
- First submitted
- 2 Jan 2007
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind Clinical Trial to Assess the Efficacy and Tolerability of Topical Azelaic Acid 15% Gel Once Daily Compared to Topical Azelaic Acid 15% gelTwice Daily in Subjects With Papulopustular Rosacea
- ClinicalTrials.gov ID
- NCT00417937
- Acronym / sponsor ID
- 14428
- Conditions
- Papulopustular Rosacea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- Jan 2007
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 4 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus twice daily in the treatment of patients with papulopustular rosacea.
Detailed description
To test the efficacy and safety of once vs twice daily application of azelaic acid 15% gel on papulopustular rosacea
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: azelaic acid 15% gelAzelaic acid 15 % gel once daily |
| 2 | Active comparator | Drug: azelaic acid 15% gelAzelaic acid 15 gel twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Papulopustular facial rosacea; minimum of 10, maximum of 50 inflamed papules and/or pustules
Key exclusion criteria (5 listed)
- Mild or severe rosacea
- Rosacea with marked ocular manifestations
- Presence of dermatoses that could interfere with the rosacea diagnosis or evaluation of the study course
- Wash out period required for patients treated prior to study with topical retinoids, oral antibiotics, topical antibiotics, systemic and topical corticosteroids, topical imidazole, laser surgery for telangiectasia
- History of hypersensitivity to propylene glycol
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 15% gel15% gel, topically applied once daily for six weeks | Drug | 1 |
| azelaic acid 15% gel15% gel, topically applied twice daily for six weeks | Drug | 2 |
Primary outcome
Investigator's global assessment scored on a seven point scale
Time frame: Measurements made during the course of treatment
1 secondary outcome
Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy
Time frame: Parameters measured during the course of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
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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
1 site 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 15% gel in people with Papulopustular Rosacea, run by LEO Pharma at 1 site in Germany.
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 5 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 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Investigator's global assessment scored on a seven point scale (time frame: Measurements made during the course of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2023.