Atopic DermatitisPhase 20405-01-04NCT01232543
Safety Study Evaluating the Adrenal Suppression Potential of Product 0405 in Pediatric Subjects With Atopic Dermatitis
A Phase 2 study testing Product 0405 in people with Atopic Dermatitis, run by Fougera Pharmaceuticals Inc. at 1 site in United States.
Trial summary
The aim of the trial is to assess Adrenal Suppression potential when pediatric subjects are administered Product 0405 for the treatment of Atopic Dermatitis Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Product 0405
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Nov 2011
- Phase
- Phase 2
- 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 3 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of Atopic Dermatitis
- Good health with the exception of Atopic Dermatitis
- Percent body surface area minimum requirements
Who cannot join
- Subjects who are pregnant, nursing, or planning a pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Fougera Pharmaceuticals Inc.
Melville, New York, 11747
About this study
Official title: An Open-Label Evaluation of the Adrenal Suppression Potential of Product 0405 in the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric Subjects
The aim of the trial is to assess Adrenal Suppression potential when pediatric subjects are administered Product 0405 for the treatment of Atopic Dermatitis
Read the detailed description
Treatment medication will be administered topically, twice a day for 4 weeks.
- Conditions
- Atopic Dermatitis
- Being tested
- Product 0405
- Keywords
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product 0405Drug
Product 0405 will be administered topically, twice daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Product 0405 | Experimental | Topical Active Investigational Product 0405 Receives: Drug: Product 0405 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression.
Measured: 4 weeks
Secondary outcomes (1)
Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionAug 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fougera Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathleen Ocasio, CCRA, Study director, Fougera Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232543
- Sponsor's protocol ID
- 0405-01-04
- Acronym
- 0405-01-04
- Status last verified
- Apr 2012
- First submitted
- 28 Oct 2010
- Last updated
- 11 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Evaluation of the Adrenal Suppression Potential of Product 0405 in the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric Subjects
- ClinicalTrials.gov ID
- NCT01232543
- Acronym / sponsor ID
- 0405-01-04 / 0405-01-04
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Fougera Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 2 Nov 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.
The aim of the trial is to assess Adrenal Suppression potential when pediatric subjects are administered Product 0405 for the treatment of Atopic Dermatitis
Detailed description
Treatment medication will be administered topically, twice a day for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Product 0405 | Experimental | Drug: Product 0405Topical Active Investigational Product 0405 |
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Clinical diagnosis of Atopic Dermatitis
- Good health with the exception of Atopic Dermatitis
- Percent body surface area minimum requirements
Key exclusion criteria (1 listed)
- Subjects who are pregnant, nursing, or planning a pregnancy
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 |
|---|---|---|
| Product 0405Product 0405 will be administered topically, twice daily for 28 days. | Drug | Product 0405 |
Primary outcome
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression.
Time frame: 4 weeks
1 secondary outcome
Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.
Time frame: 4 weeks
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 11 Apr 2012.
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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.
Kathleen Ocasio, CCRA study director
Fougera Pharmaceuticals Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Product 0405 in people with Atopic Dermatitis, run by Fougera Pharmaceuticals Inc. 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 3 inclusion and 1 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 11 Apr 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression. (time frame: 4 weeks). 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 11 Apr 2012.