Atopic DermatitisPhase 4NCT00810862
Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children
A Phase 4 study testing pimecrolimus active cream in people with Atopic Dermatitis, run by Children's Hospital of Michigan.
Trial summary
Primecrolimus cream 1% is effective in the treatment of atopic dermatitis in African American children. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- pimecrolimus active cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Jun 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- African American children aged 2 to 17 years
- mild to moderate atopic dermatitis
Who cannot join
- m-EASI less than 3 at baseline
- allergy to Elidel or components
- use of oral steroids, immunosuppressive agents,cytostatics of phototherapy within 4 weeks prior to study.
- previous continuous or non-continuous use of pimecrolimus or tacrolimus for greater than 11 months within 2 weeks of enrollment.
- active skin infections.
- immunocompromised patients.
Show all 10Show fewer
- previous history of skin cancer or lymphoma
- any hypopigmentation in study areas
- pregnant or breastfeeding
- participation in another investigational trial
About this study
Official title: A 3-Week, Single-Blind, Placebo-Controlled, Within-Patient, Randomized Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children
Primecrolimus cream 1% is effective in the treatment of atopic dermatitis in African American children.
- Conditions
- Atopic Dermatitis
- Being tested
- pimecrolimus active cream, placebo base cream
- Keywords
- African American children
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pimecrolimus active creamDrug
Also called Elidel 1% cream Novartis Pharmaceuticals
Pimecrolimus 1% cream apply to affected study area twice daily for 21 days
placebo base creamOther
Also called Elidel base cream without active agent, by Novartis Pharmaceuticals
apply to affected study area twice daily for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Pimecrolimus | Experimental | Pimecrolimus 1% cream Receives: Drug: pimecrolimus active cream |
| 2 | Placebo comparator | Placebo cream over affected study area Receives: Other: placebo base cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in modified Modified EASI score a dermatologic evaluation of response to topical therapy for atopic dermatitis
Measured: at baseline, one week and three weeks following treatment initiation
Secondary outcomes (2)
modified IGA score
Measured: at baseline, one week and three weeks following initiation of therapy
hypopigmentation scale score
Measured: baseline, one and three weeks following initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startNov 2006
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Lack of subject enrollment over the past two years.
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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810862
- Sponsor's protocol ID
- pimecrolimus1
- Status last verified
- Dec 2008
- First submitted
- 17 Dec 2008
- Last updated
- 18 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-Week, Single-Blind, Placebo-Controlled, Within-Patient, Randomized Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children
- ClinicalTrials.gov ID
- NCT00810862
- Acronym / sponsor ID
- pimecrolimus1
- Conditions
- Atopic Dermatitis
- Keywords
- African American children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of subject enrollment over the past two years.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Children's Hospital of MichiganUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Nov 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 18 Dec 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.
Primecrolimus cream 1% is effective in the treatment of atopic dermatitis in African American children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pimecrolimus | Experimental | Drug: pimecrolimus active creamPimecrolimus 1% cream |
| 2 | Placebo comparator | Other: placebo base creamPlacebo cream over affected study area |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- African American children aged 2 to 17 years
- mild to moderate atopic dermatitis
Key exclusion criteria (10 listed)
- m-EASI less than 3 at baseline
- allergy to Elidel or components
- use of oral steroids, immunosuppressive agents,cytostatics of phototherapy within 4 weeks prior to study.
- previous continuous or non-continuous use of pimecrolimus or tacrolimus for greater than 11 months within 2 weeks of enrollment.
- active skin infections.
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 |
|---|---|---|
| pimecrolimus active creamAlso: Elidel 1% cream Novartis PharmaceuticalsPimecrolimus 1% cream apply to affected study area twice daily for 21 days | Drug | Pimecrolimus |
| placebo base creamAlso: Elidel base cream without active agent, by Novartis Pharmaceuticalsapply to affected study area twice daily for 21 days | Other | 2 |
Primary outcome
Mean change in modified Modified EASI score a dermatologic evaluation of response to topical therapy for atopic dermatitis
Time frame: at baseline, one week and three weeks following treatment initiation
2 secondary outcomes
modified IGA score
Time frame: at baseline, one week and three weeks following initiation of therapy
hypopigmentation scale score
Time frame: baseline, one and three weeks following initiation of treatment
Results and safety
The study was stopped early (reason given: Lack of subject enrollment over the past two years.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pimecrolimus active cream in people with Atopic Dermatitis, run by Children's Hospital of Michigan.
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 10 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: stopped early, as of the sponsor's last update on 18 Dec 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. 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 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 was stopped early (reason given: Lack of subject enrollment over the past two years.). Results are not available in the source record.
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?
Mean change in modified Modified EASI score a dermatologic evaluation of response to topical therapy for atopic dermatitis (time frame: at baseline, one week and three weeks following treatment initiation). 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 18 Dec 2008.