Papulopustular RosaceaPhase 1NCT01257919
Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea
A Phase 1 study testing Azelaic Acid Foam and Azelaic Acid Gel in people with Papulopustular Rosacea, run by LEO Pharma at 1 site in United States.
Trial summary
Assessment of pharmacokinetics of Azelaic Acid Foam after repeated skin application and in comparison to Azelaic Acid gel. Assessment of safety after repeated skin application. 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 and Azelaic Acid Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Mar 2011
- Phase
- Phase 1
- 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
- diagnosis of moderate papulopustular rosacea
- free of any clinically significant disease
Who cannot join
- body weight less than 50 or more than 130 kg
- clinically significant disease which could interfere with the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Novum Pharmaceutical Research Services of Nevada Inc.
Las Vegas, Nevada, 89121
About this study
Official title: Investigator-blinded, Randomized, Cross-over, Multiple Dose Phase I Study on Safety and Pharmacokinetics of Topically Applied Azelaic Acid Foam, 15% Compared to Azelaic Acid Gel, 15% in Subjects With Papulopustular Rosacea
Assessment of pharmacokinetics of Azelaic Acid Foam after repeated skin application and in comparison to Azelaic Acid gel.
Assessment of safety after repeated skin application.
- Conditions
- Papulopustular Rosacea
- Being tested
- Azelaic Acid Foam, Azelaic Acid 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 FoamDrug
Dermal application of Azelaic Acid Foam
Azelaic Acid GelDrug
Dermal application of Azelaic Acid Gel
| Study group | Role | What they receive |
|---|---|---|
| Azelaic Acid Foam 15% | Experimental | Dermal application of Azelaic Acid Foam 15% Receives: Drug: Azelaic Acid Foam |
| Azelaic Acid Gel 15% | Active comparator | Dermal application of Azelaic Acid Gel 15% Receives: Drug: Azelaic Acid Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline corrected area under the curve (AUC)
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionMar 2011
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 21 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
- NCT01257919
- Sponsor's protocol ID
- 15386
- Other IDs
- 1401843
- Status last verified
- Feb 2014
- First submitted
- 9 Dec 2010
- 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
- Investigator-blinded, Randomized, Cross-over, Multiple Dose Phase I Study on Safety and Pharmacokinetics of Topically Applied Azelaic Acid Foam, 15% Compared to Azelaic Acid Gel, 15% in Subjects With Papulopustular Rosacea
- ClinicalTrials.gov ID
- NCT01257919
- Acronym / sponsor ID
- 15386
- Conditions
- Papulopustular Rosacea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Dec 2010 (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.
Assessment of pharmacokinetics of Azelaic Acid Foam after repeated skin application and in comparison to Azelaic Acid gel.
Assessment of safety after repeated skin application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azelaic Acid Foam 15% | Experimental | Drug: Azelaic Acid FoamDermal application of Azelaic Acid Foam 15% |
| Azelaic Acid Gel 15% | Active comparator | Drug: Azelaic Acid GelDermal application of Azelaic Acid Gel 15% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of moderate papulopustular rosacea
- free of any clinically significant disease
Key exclusion criteria (2 listed)
- body weight less than 50 or more than 130 kg
- clinically significant disease which could interfere with 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 FoamDermal application of Azelaic Acid Foam | Drug | Azelaic Acid Foam 15% |
| Azelaic Acid GelDermal application of Azelaic Acid Gel | Drug | Azelaic Acid Gel 15% |
Primary outcome
Baseline corrected area under the curve (AUC)
Time frame: 12 hours
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 1 study testing Azelaic Acid Foam and Azelaic Acid Gel in people with Papulopustular Rosacea, run by LEO Pharma at 1 site 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 2 inclusion and 2 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Baseline corrected area under the curve (AUC) (time frame: 12 hours). 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.