HealthyPhase 1NCT01430312
21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation
A Phase 1 study testing azelaic acid pre-foam formulation, Water and Sodium lauryl sulfate in people with Healthy, run by LEO Pharma at 1 site in United States.
Trial summary
The purpose of this study is to determine the irritancy potential of azelaic acid pre-foam formulation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- azelaic acid pre-foam formulation, Water and Sodium lauryl sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
- male ore female subjects
- aged 18 - 65 years
- ability to understand and fulfill the study requirements
Who cannot join
- affected skin in designated test area
- pregnancy or lactation
- not willing to comply with study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Vehicle-controlled Phase 1 Dermal Safety Study Using a 21 Day Cumulative Irritant Patch Test Design to Evaluate the Local Tolerability of Azelaic Acid Pre-Foam Formulation in Healthy Volunteers
The purpose of this study is to determine the irritancy potential of azelaic acid pre-foam formulation.
Read the detailed description
This is the standard patch test over 21 days of exposure of the test product,its vehicle and a positive as well as a negative control.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azelaic acid pre-foam formulationDrug
Vehicle pre-foam formulationDrug
WaterDrug
Sodium lauryl sulfateDrug
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Topical application of verum (azelaic acid pre-foam formulation) on the skin Receives: Drug: azelaic acid pre-foam formulation |
| Vehicle | Placebo comparator | Topical application of vehicle formulation (same as verum but without active drug substance) on the skin Receives: Drug: Vehicle pre-foam formulation |
| Negative control | Placebo comparator | Topical application of distilled water (negative control) on the skin Receives: Drug: Water |
| Positive control | Active comparator | Topical application of 0.5% Sodium Lauryl sulfate (positive control) on the skin Receives: Drug: Sodium lauryl sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
irritancy rating scale
skin reaction as well as superficial layer effects will be scored according to standardized scales
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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
- NCT01430312
- Sponsor's protocol ID
- 15853
- Other IDs
- 1401841
- Status last verified
- Feb 2014
- First submitted
- 6 Sep 2011
- Last updated
- 1 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Vehicle-controlled Phase 1 Dermal Safety Study Using a 21 Day Cumulative Irritant Patch Test Design to Evaluate the Local Tolerability of Azelaic Acid Pre-Foam Formulation in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01430312
- Acronym / sponsor ID
- 15853
- Conditions
- Healthy
- Keywords
- dermal irritative potential
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 8 Sep 2011 (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.
The purpose of this study is to determine the irritancy potential of azelaic acid pre-foam formulation.
Detailed description
This is the standard patch test over 21 days of exposure of the test product,its vehicle and a positive as well as a negative control.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Drug: azelaic acid pre-foam formulationTopical application of verum (azelaic acid pre-foam formulation) on the skin |
| Vehicle | Placebo comparator | Drug: Vehicle pre-foam formulationTopical application of vehicle formulation (same as verum but without active drug substance) on the skin |
| Negative control | Placebo comparator | Drug: WaterTopical application of distilled water (negative control) on the skin |
| Positive control | Active comparator | Drug: Sodium lauryl sulfateTopical application of 0.5% Sodium Lauryl sulfate (positive control) on the skin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- healthy volunteers
- male ore female subjects
- aged 18 - 65 years
- ability to understand and fulfill the study requirements
Key exclusion criteria (3 listed)
- affected skin in designated test area
- pregnancy or lactation
- not willing to comply with study requirements
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 pre-foam formulation | Drug | Verum |
| Vehicle pre-foam formulation | Drug | Vehicle |
| Water | Drug | Negative control |
| Sodium lauryl sulfate | Drug | Positive control |
Primary outcome
irritancy rating scale
Time frame: 21 days
skin reaction as well as superficial layer effects will be scored according to standardized scales
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 1 Apr 2020.
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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 pre-foam formulation, Water and Sodium lauryl sulfate in people with Healthy, 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 4 inclusion and 3 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 1 Apr 2020. 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. 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 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?
irritancy rating scale (time frame: 21 days). 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 1 Apr 2020.