Atopic DermatitisPhase 4NCT00828412
Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis
A Phase 4 study testing EpiCeram Skin Barrier Emulsion and Desonide Cream 0.05% in people with Atopic Dermatitis, run by Promius Pharma, LLC at 5 sites in United States.
Trial summary
This study compares the effectiveness of two topical creams for atopic dermatitis in pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice daily for 6 weeks or until clear. Read more about this study
- Who is it for?
- Ages 3 months to 12 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- EpiCeram Skin Barrier Emulsion and Desonide Cream 0.05%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2009to Aug 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- at least 3 months of age and less than 13 years of age
- atopic dermatitis of moderate severity
Who cannot join
- pregnant or lactating
- treatment of atopic dermatitis with topical product in the 14 days prior to Baseline
- treatment of atopic dermatitis with systemic product in the 30 days prior to Baseline
- serious or uncontrolled medical condition
- active infection
- significant use of inhaled, intranasal, or intraocular corticosteroid
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northwestern University
Chicago, Illinois, 60611
Dermatology Research Associates
Cincinnati, Ohio, 45230
National Jewish Health
Denver, Colorado, 80206
University of Texas
Houston, Texas, 77030
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized, Investigator-Blind, Six-Week, Parallel Group, Multicenter Pilot Study to Compare the Safety and Efficacy of EpiCeram Skin Barrier Emulsion and Desonide Cream 0.05% in the Twice Daily Treatment of Pediatric Subjects With Moderate Atopic Dermatitis
This study compares the effectiveness of two topical creams for atopic dermatitis in pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice daily for 6 weeks or until clear.
- Conditions
- Atopic Dermatitis
- Being tested
- EpiCeram Skin Barrier Emulsion, Desonide Cream 0.05%
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiCeram Skin Barrier EmulsionDevice
topical cream, twice daily, 6 weeks
Desonide Cream 0.05%Drug
topical cream, twice daily, 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | EpiCeram Skin Barrier Emulsion Receives: Device: EpiCeram Skin Barrier Emulsion |
| 2 | Active comparator | Desonide Cream 0.05% Receives: Drug: Desonide Cream 0.05% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Three Item Severity Score
The average of the sum of scores for erythema, edema/papulation, and excoriation for two target lesions. Scoring on a scale of 0 to 3 (none to severe). Maximum score is 9.
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promius Pharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanne Fraser, PhD, Study director, Promius Pharma, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828412
- Sponsor's protocol ID
- EPC0801
- Status last verified
- Dec 2016
- First submitted
- 21 Jan 2009
- Last updated
- 30 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Investigator-Blind, Six-Week, Parallel Group, Multicenter Pilot Study to Compare the Safety and Efficacy of EpiCeram Skin Barrier Emulsion and Desonide Cream 0.05% in the Twice Daily Treatment of Pediatric Subjects With Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00828412
- Acronym / sponsor ID
- EPC0801
- Conditions
- Atopic Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Promius Pharma, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 26 Jan 2009 (estimated)
- Results
- Posted 9 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the effectiveness of two topical creams for atopic dermatitis in pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice daily for 6 weeks or until clear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: EpiCeram Skin Barrier EmulsionEpiCeram Skin Barrier Emulsion |
| 2 | Active comparator | Drug: Desonide Cream 0.05%Desonide Cream 0.05% |
Who may qualify
- Ages
- 3 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- at least 3 months of age and less than 13 years of age
- atopic dermatitis of moderate severity
Key exclusion criteria (6 listed)
- pregnant or lactating
- treatment of atopic dermatitis with topical product in the 14 days prior to Baseline
- treatment of atopic dermatitis with systemic product in the 30 days prior to Baseline
- serious or uncontrolled medical condition
- active infection
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 |
|---|---|---|
| EpiCeram Skin Barrier Emulsiontopical cream, twice daily, 6 weeks | Device | 1 |
| Desonide Cream 0.05%topical cream, twice daily, 6 weeks | Drug | 2 |
Primary outcome
Change From Baseline in Three Item Severity Score
Time frame: Baseline to 6 weeks
The average of the sum of scores for erythema, edema/papulation, and excoriation for two target lesions. Scoring on a scale of 0 to 3 (none to severe). Maximum score is 9.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joanne Fraser, PhD study director
Promius Pharma, LLC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EpiCeram Skin Barrier Emulsion and Desonide Cream 0.05% in people with Atopic Dermatitis, run by Promius Pharma, LLC at 5 sites 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 6 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 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 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?
Yes. Results are posted in the registry (first posted 9 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Three Item Severity Score (time frame: Baseline to 6 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 30 Jan 2017.