Atopic DermatitisPhase 4NCT00616538
Epiceram™ Device Versus Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) for Treatment of Atopic Dermatitis
A Phase 4 study testing Epiceram(r) and Fluticasone Propionate 0.05% in people with Atopic Dermatitis, run by Ceragenix Pharmaceuticals.
Trial summary
Novel therapies for AD that avoid immunosuppression and potential carcinogensis are needed. EpiCeram™ , a topical cream, represents a novel class of therapy for skin disorders that does not contain corticosteroids or other anti-inflammatory drugs. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Epiceram(r) and Fluticasone Propionate 0.05%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Apr 2007
- Phase
- Phase 4
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects willing to provide written informed consent (i.e. assent with parental/guardian consent for ages > 7 to 18 years and parental consent for ages 6 months to 7 years) to participate in the study
- Males or Females
- Age: 6 months to 18 years
- Diagnosis of Moderate to Severe Atopic Dermatitis (AD) on the basis of criteria defined by the Rajka-Langland Severity Index
Who cannot join
- Subjects with mild AD as defined by the Rajka-Laneland Severity Index.
- Subjects having greater than 20% BSA as measured by SCORAD "Extent" (A) score (total amount of body surface area requiring application of either Cutivate® or EpiCeram® exceeds 20%)
- Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
- Subjects who require greater than 2mg per day of inhaled or intranasal steroids.
- Subjects who are currently participating in, or have participated in another investigational drug/device trial within the past month.
- Subjects with known allergy to or hypersensitivity to EpiCeram™ or Fluticasone or Cetaphil.
- Active infection of any type at the start of the study.
About this study
Official title: Prospective, Randomized, Investigator-Blind, Controlled, Pilot Study Comparing Effect of Epiceram™ Device vs Standard of Care Therapy of Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) in Treatment of Atopic Dermatitis in Pediatric Subjects
Novel therapies for AD that avoid immunosuppression and potential carcinogensis are needed. EpiCeram™ , a topical cream, represents a novel class of therapy for skin disorders that does not contain corticosteroids or other anti-inflammatory drugs. The objective of the present study is to demonstrate the safety and efficacy of EpiCeram ™ in the treatment of moderate to severe atopic dermatitis as compared to mid-strength topical steroid cream following twice daily dosing for four weeks in pediatric patients with AD. The potential benefit to patients lies in the potential for EpiCeram ™ to provide restoration of the normal skin barrier as shown in previous studies and eliminate or reduce the requirement for supplemental topical steroid administration.
- Conditions
- Atopic Dermatitis
- Being tested
- Epiceram(r), Fluticasone Propionate 0.05%
- Keywords
- Atopic, Dermatitis, eczema, skin barrier, ceramide, topical, inflamation, steroid, SCORAD, glucocorticoids, EpiCeram, Cutivate, fluticasone
- Medical subject headings
- Dermatitis, Atopic, Dermatitis, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epiceram(r)Device
Topical barrier repair emulsion cream
Fluticasone Propionate 0.05%Drug
Topical mid-strength steroid
| Study group | Role | What they receive |
|---|---|---|
| Cutivate(r) | Active comparator | Topical mid-strength steroid Receives: Drug: Fluticasone Propionate 0.05% |
| EpiCeram(r) | Experimental | EpiCeram(r) topical barrier repair cream. Receives: Device: Epiceram(r) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD)
Measured: 4 weeks
Secondary outcomes (2)
Percentage of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA)
Measured: 4 weeks
Change in assessments of Pruritus and sleep habits
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startDec 2006
- Primary completionApr 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ceragenix Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeffrey Sugarman, MD, Principal investigator, University of California, San Francisco, CALawrence Parrish, MD, Principal investigator, Medical College of Thomas Jefferson University, Philadelphia, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616538
- Sponsor's protocol ID
- CPI 2006-002
- Status last verified
- Feb 2008
- First submitted
- 5 Feb 2008
- Last updated
- 15 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Investigator-Blind, Controlled, Pilot Study Comparing Effect of Epiceram™ Device vs Standard of Care Therapy of Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) in Treatment of Atopic Dermatitis in Pediatric Subjects
- ClinicalTrials.gov ID
- NCT00616538
- Acronym / sponsor ID
- CPI 2006-002
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic, Dermatitis, eczema, skin barrier, ceramide, topical, inflamation, steroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Ceragenix PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Apr 2007 (actual)
- First posted
- 15 Feb 2008 (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.
Novel therapies for AD that avoid immunosuppression and potential carcinogensis are needed. EpiCeram™ , a topical cream, represents a novel class of therapy for skin disorders that does not contain corticosteroids or other anti-inflammatory drugs. The objective of the present study is to demonstrate the safety and efficacy of EpiCeram ™ in the treatment of moderate to severe atopic dermatitis as compared to mid-strength topical steroid cream following twice daily dosing for four weeks in pediatric patients with AD. The potential benefit to patients lies in the potential for EpiCeram ™ to provide restoration of the normal skin barrier as shown in previous studies and eliminate or reduce the requirement for supplemental topical steroid administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cutivate(r) | Active comparator | Drug: Fluticasone Propionate 0.05%Topical mid-strength steroid |
| EpiCeram(r) | Experimental | Device: Epiceram(r)EpiCeram(r) topical barrier repair cream. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Subjects willing to provide written informed consent (i.e. assent with parental/guardian consent for ages > 7 to 18 years and parental consent for ages 6 months to 7 years) to participate in the study
- Males or Females
- Age: 6 months to 18 years
- Diagnosis of Moderate to Severe Atopic Dermatitis (AD) on the basis of criteria defined by the Rajka-Langland Severity Index
Key exclusion criteria (7 listed)
- Subjects with mild AD as defined by the Rajka-Laneland Severity Index.
- Subjects having greater than 20% BSA as measured by SCORAD "Extent" (A) score (total amount of body surface area requiring application of either Cutivate® or EpiCeram® exceeds 20%)
- Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
- Subjects who require greater than 2mg per day of inhaled or intranasal steroids.
- Subjects who are currently participating in, or have participated in another investigational drug/device trial within the past month.
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(r)Topical barrier repair emulsion cream | Device | EpiCeram(r) |
| Fluticasone Propionate 0.05%Topical mid-strength steroid | Drug | Cutivate(r) |
Primary outcome
Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD)
Time frame: 4 weeks
2 secondary outcomes
Percentage of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA)
Time frame: 4 weeks
Change in assessments of Pruritus and sleep habits
Time frame: week 4
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 15 Feb 2008.
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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.
Jeffrey Sugarman, MD principal investigator
University of California, San Francisco, CA
Lawrence Parrish, MD principal investigator
Medical College of Thomas Jefferson University, Philadelphia, PA
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epiceram(r) and Fluticasone Propionate 0.05% in people with Atopic Dermatitis, run by Ceragenix Pharmaceuticals.
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 7 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 15 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD) (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 15 Feb 2008.