HealthyPhase 1NCT01430533
Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation
A Phase 1 study testing azelaic acid pre foam formulation and Water 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 dermal sensitization 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 and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 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 or 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 to Evaluate the Sensitizing Potential of Topically Applied Azelaic Acid Pre-foam Formulation in Healthy Subjects Using a Human Repeated Insult Patch Test Design
The purpose of this study is to determine the dermal sensitization potential of azelaic acid pre-foam formulation.
Read the detailed description
In an induction phase a three times weekly exposure over three weeks will be performed, followed by a resting phase. In a following challenge phase single exposure will be performed again and potential skin reactions observed. If skin reactions occur an optional re-challenge phase may be performed.
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
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin sensitization reaction
skin reactions will be assessed, using a standardized scoring scale
Measured: day 3 to 6 of challenge phase week (week 6 or later, at least 2 weeks after the 3 week induction phase)
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
- 240 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
- NCT01430533
- Sponsor's protocol ID
- 15854
- Other IDs
- 1401842
- 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 to Evaluate the Sensitizing Potential of Topically Applied Azelaic Acid Pre-foam Formulation in Healthy Subjects Using a Human Repeated Insult Patch Test Design
- ClinicalTrials.gov ID
- NCT01430533
- Acronym / sponsor ID
- 15854
- Conditions
- Healthy
- Keywords
- dermal sensitization potential
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 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 dermal sensitization potential of azelaic acid pre-foam formulation.
Detailed description
In an induction phase a three times weekly exposure over three weeks will be performed, followed by a resting phase. In a following challenge phase single exposure will be performed again and potential skin reactions observed. If skin reactions occur an optional re-challenge phase may be performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| 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 |
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 or 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 |
Primary outcome
skin sensitization reaction
Time frame: day 3 to 6 of challenge phase week (week 6 or later, at least 2 weeks after the 3 week induction phase)
skin reactions will be assessed, using a standardized scoring scale
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 and Water 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?
skin sensitization reaction (time frame: day 3 to 6 of challenge phase week (week 6 or later, at least 2 weeks after the 3 week induction phase)). 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.