Atopic DermatitisPhase 4NCT00460083
Epiceram Versus Elidel for Treatment of Mild to Moderate Atopic Dermatitis
A Phase 4 study testing Elidel(R) (pimecrolimus 1%) and EpiCeram(R) -ceramide based barrier repair cream in people with Atopic Dermatitis, run by Ceragenix Pharmaceuticals at 2 sites in United States.
Trial summary
Atopic dermatitis (AD) is a common skin disease that has increased in prevalence worldwide two- to threefold over the last 50 years. Epiceram, a newly FDA-approved medical device is a topical barrier repair cream designed to deliver special epidermal lipids to the top layers of the skin in order to correct skin… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Elidel(R) (pimecrolimus 1%) and EpiCeram(R) -ceramide based barrier repair cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2007to Feb 2008
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males or females of any race 2 - 12 years of age.
- Diagnosis of atopic dermatitis on the basis of the criteria defined by Hanifin and Rajka (Hanifin, 1980).
- Rajka-Langeland Severity Index score of mild to moderate (Rajka, 1989).
- At least one antecubital or popliteal fossa must be affected at the time of enrollment to serve as a target site.
Who cannot join
- Subjects with severe AD as determined by the Rajka-Langeland Severity Index (Rajka 1989).
- Disease severity requiring medium-potency topical steroid medication to treat their atopic dermatitis more than 1 week per month.
- Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
- Subjects who require greater than 2.0 mg/day inhaled or intranasal corticosteroids.
- Subjects who are currently participating in or, within the past 28 days, have participated in another study using an investigational drug.
- Subjects with a history of allergy or hypersensitivity to Epiceram, Elidel, or ingredients therein, including fragrances.
Show all 9Show fewer
- Active infection of any type at the start of the study.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
- Subjects must have not used any topical or systemic therapy during the washout periods.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized, Double-Blinded Study of Epiceram Versus Elidel in Pediatric Subjects With Mild to Moderate Atopic Dermatitis
Atopic dermatitis (AD) is a common skin disease that has increased in prevalence worldwide two- to threefold over the last 50 years. Epiceram, a newly FDA-approved medical device is a topical barrier repair cream designed to deliver special epidermal lipids to the top layers of the skin in order to correct skin barrier abnormalities found in atopic dermatitis. Epiceram does not contain corticosteroids or other conventional anti-inflammatory components and represents a novel class of skin barrier repair therapy for inflammatory skin disease.
The objective of this study is to determine whether Epiceram is a safe and effective therapy for mild to moderate atopic dermatitis and whether it may serve as an alternative to Elidel therapy.
Read the detailed description
Atopic dermatitis (AD) is a common skin disease that has increased in prevalence worldwide two- to threefold over the last 50 years. Current standard of care for atopic dermatitis includes topical corticosteroids and calcineurin inhibitors, such as Elidel and Protopic. The chronic use of topical corticosteroids is limited by side effects including skin atrophy, striae, and even HPA axis suppression. The long-term effects of skin immunosuppression with calcineurin inhibitors are unknown and although not proven, a theoretical risk of skin cancer exists. Novel therapies for atopic dermatitis that avoid immunosupression are greatly needed.
Epiceram, a newly FDA-approved medical device is a topical barrier repair cream designed to deliver special epidermal lipids to the top layers of the skin in order to correct skin barrier abnormalities found in atopic dermatitis. Epiceram does not contain corticosteroids or other conventional anti-inflammatory components and represents a novel class of skin barrier repair therapy for inflammatory skin disease. The objective of this study is to determine whether Epiceram is a safe and effective therapy for mild to moderate atopic dermatitis and whether it may serve as an alternative to Elidel therapy.
- Conditions
- Atopic Dermatitis
- Being tested
- Elidel(R) (pimecrolimus 1%), EpiCeram(R) -ceramide based barrier repair cream
- Keywords
- Atopic Dermatitis, eczema, dermatitis, skin barrier, barrier repair, ceramide, physiologic lipid, pruritus, Elidel, Epiceram, topical steroid
- Medical subject headings
- Dermatitis, Atopic, Eczema, Dermatitis, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elidel(R) (pimecrolimus 1%)Drug
EpiCeram(R) -ceramide based barrier repair creamDevice
| Study group | Role | What they receive |
|---|---|---|
| Elidel(r) | Active comparator | Not described Receives: Drug: Elidel(R) (pimecrolimus 1%) |
| Epiceram(r) | Experimental | Not described Receives: Device: EpiCeram(R) -ceramide based barrier repair cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy outcome is the change in mean Eczema Area and Severity Index (EASI) score in both groups.
Measured: 4 weeks
Secondary outcomes (5)
Percent of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA) at week 4.
Measured: 4 weeks
Change in mean capacitance in lesional and nonlesional skin at target site
Measured: 4 weeks
Change in mean transepidermal water loss (TEWL) in lesional and nonlesional skin at target site
Measured: 4 weeks
Change in pruritus score measured with a visual analog scale
Measured: 4 weeks
Comparison of baseline and Week 4 Children's Dermatitis Life Quality Index (CDLQI)
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 posted13 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2007
- Study completionFeb 2008
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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ceragenix Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eric Simpson, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460083
- Sponsor's protocol ID
- CGXP - 060674/ IRB00002569
- Status last verified
- Feb 2008
- First submitted
- 11 Apr 2007
- Last updated
- 6 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded Study of Epiceram Versus Elidel in Pediatric Subjects With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00460083
- Acronym / sponsor ID
- CGXP - 060674/ IRB00002569
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, eczema, dermatitis, skin barrier, barrier repair, ceramide, physiologic lipid, pruritus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ceragenix PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 13 Apr 2007 (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.
Atopic dermatitis (AD) is a common skin disease that has increased in prevalence worldwide two- to threefold over the last 50 years. Epiceram, a newly FDA-approved medical device is a topical barrier repair cream designed to deliver special epidermal lipids to the top layers of the skin in order to correct skin barrier abnormalities found in atopic dermatitis. Epiceram does not contain corticosteroids or other conventional anti-inflammatory components and represents a novel class of skin barrier repair therapy for inflammatory skin disease.
The objective of this study is to determine whether Epiceram is a safe and effective therapy for mild to moderate atopic dermatitis and whether it may serve as an alternative to Elidel therapy.
Detailed description
Atopic dermatitis (AD) is a common skin disease that has increased in prevalence worldwide two- to threefold over the last 50 years. Current standard of care for atopic dermatitis includes topical corticosteroids and calcineurin inhibitors, such as Elidel and Protopic. The chronic use of topical corticosteroids is limited by side effects including skin atrophy, striae, and even HPA axis suppression. The long-term effects of skin immunosuppression with calcineurin inhibitors are unknown and although not proven, a theoretical risk of skin cancer exists. Novel therapies for atopic dermatitis that avoid immunosupression are greatly needed.
Epiceram, a newly FDA-approved medical device is a topical barrier repair cream designed to deliver special epidermal lipids to the top layers of the skin in order to correct skin barrier abnormalities found in atopic dermatitis. Epiceram does not contain corticosteroids or other conventional anti-inflammatory components and represents a novel class of skin barrier repair therapy for inflammatory skin disease. The objective of this study is to determine whether Epiceram is a safe and effective therapy for mild to moderate atopic dermatitis and whether it may serve as an alternative to Elidel therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elidel(r) | Active comparator | Drug: Elidel(R) (pimecrolimus 1%) |
| Epiceram(r) | Experimental | Device: EpiCeram(R) -ceramide based barrier repair cream |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Males or females of any race 2 - 12 years of age.
- Diagnosis of atopic dermatitis on the basis of the criteria defined by Hanifin and Rajka (Hanifin, 1980).
- Rajka-Langeland Severity Index score of mild to moderate (Rajka, 1989).
- At least one antecubital or popliteal fossa must be affected at the time of enrollment to serve as a target site.
Key exclusion criteria (9 listed)
- Subjects with severe AD as determined by the Rajka-Langeland Severity Index (Rajka 1989).
- Disease severity requiring medium-potency topical steroid medication to treat their atopic dermatitis more than 1 week per month.
- Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
- Subjects who require greater than 2.0 mg/day inhaled or intranasal corticosteroids.
- Subjects who are currently participating in or, within the past 28 days, have participated in another study using an investigational drug.
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 |
|---|---|---|
| Elidel(R) (pimecrolimus 1%) | Drug | Elidel(r) |
| EpiCeram(R) -ceramide based barrier repair cream | Device | Epiceram(r) |
Primary outcome
The primary efficacy outcome is the change in mean Eczema Area and Severity Index (EASI) score in both groups.
Time frame: 4 weeks
5 secondary outcomes
Percent of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA) at week 4.
Time frame: 4 weeks
Change in mean capacitance in lesional and nonlesional skin at target site
Time frame: 4 weeks
Change in mean transepidermal water loss (TEWL) in lesional and nonlesional skin at target site
Time frame: 4 weeks
Change in pruritus score measured with a visual analog scale
Time frame: 4 weeks
Comparison of baseline and Week 4 Children's Dermatitis Life Quality Index (CDLQI)
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 6 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.
Eric Simpson, MD principal investigator
Oregon Health and Science University
2 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 Elidel(R) (pimecrolimus 1%) and EpiCeram(R) -ceramide based barrier repair cream in people with Atopic Dermatitis, run by Ceragenix Pharmaceuticals at 2 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 4 inclusion and 9 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 6 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
The primary efficacy outcome is the change in mean Eczema Area and Severity Index (EASI) score in both groups. (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 6 Feb 2008; AzTrials last refreshed its copy on 8 Nov 2026.