Dermatitis, AtopicPhase 4NCT00106496
A Multi-Center Study of Short and Long-term Use of Protopic Ointment in Patients With Atopic Dermatitis
A Phase 4 study testing Protopic and Corticosteroid in people with Dermatitis, Atopic, run by Astellas Pharma Inc at 24 sites in United States.
Trial summary
The purpose of the study is to determine the impact of topical corticosteroids on the safety and effectiveness of Protopic Ointment in the short-term treatment of moderate to severe Atopic Dermatitis and to compare the safety and effectiveness of Protopic Ointment to placebo in the long-term management of Atopic… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Protopic and Corticosteroid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 410 participants
- Where
- 24 sitesUnited States
- Study dates
- Oct 2004to Jul 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient must have Atopic Dermatitis
- Patient must be at least 2 years of age
Who cannot join
- Patient is pregnant or breast feeding an infant
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Investigational Site
Ann Arbor, Michigan, 48109
Investigational Site
Atlanta, Georgia, 30322
Study site
Baltimore, Maryland, 21205
Investigational Site
Birmingham, Alabama, 35205
Investigational Site
Chicago, Illinois, 60611
Study site
Chicago, Illinois, 60612
Investigational Site
Chicago, Illinois, 60614
Investigational Site
Cincinnati, Ohio, 45219
Investigational Site
Dallas, Texas, 75230
Investigational Site
Dallas, Texas, 75390
Investigational Site
Detroit, Michigan, 48202
Investigational Site
Irvine, California, 92697
Investigational Site
Lebanon, New Hampshire, 03756
Study site
Lexington, Kentucky, 40536
Investigational Site
Loma Linda, California, 92354
Study site
Miami, Florida, 33136
Investigational Site
Nashville, Tennessee, 37215
Study site
New Haven, Connecticut, 06519
Investigational Site
New York, New York, 10029
Investigational Site
Philadelphia, Pennsylvania, 19115
Investigational Site
Portland, Oregon, 97201
Investigational Site
San Diego, California, 92123
Investigational Site
St Louis, Missouri, 63110
Investigational Site
Winston-Salem, North Carolina, 27157
About this study
Official title: A Multi-Center Study to Assess the Impact of Topical Corticosteroids on the Safety and Efficacy of Protopic Ointment in the Short-Term Treatment of Atopic Dermatitis and to Assess Protopic in the Long-term Management of Atopic Dermatitis
The purpose of the study is to determine the impact of topical corticosteroids on the safety and effectiveness of Protopic Ointment in the short-term treatment of moderate to severe Atopic Dermatitis and to compare the safety and effectiveness of Protopic Ointment to placebo in the long-term management of Atopic Dermatitis
Read the detailed description
Study includes an interim short-term, open label period. Patients could also receive a second course of open label treatment dependent on disease exacerbation.
- Conditions
- Dermatitis, Atopic
- Being tested
- Protopic, Corticosteroid, placebo
- Keywords
- Treatment Effectiveness, Treatment Efficacy, Immunomodulator, Topical, Tacrolimus, Topical, Dermatitis, Atopic, Eczema, Atopic, 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.
ProtopicDrug
Also called tacrolimus ointment, FK506 ointment
topical
CorticosteroidDrug
topical
placeboDrug
topical
| Study group | Role | What they receive |
|---|---|---|
| 1A | Experimental | Not described Receives: Drug: Protopic |
| 1B | Active comparator | Not described Receives: Drug: Corticosteroid |
| 2 | Experimental | Open label Receives: Drug: Protopic |
| 3A | Experimental | Not described Receives: Drug: Protopic |
| 3B | Placebo comparator | Not described Receives: Drug: placebo |
| 4 | Experimental | Open label Receives: Drug: Protopic |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatment
Measured: 2 weeks
Secondary outcomes (1)
Percentage of patients reporting cutaneous adverse events overall
Measured: Day 4 through end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2005 (estimated)
- Study startOct 2004
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106496
- Sponsor's protocol ID
- 20-04-002
- Status last verified
- Sep 2014
- First submitted
- 25 Mar 2005
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Breneman D, Fleischer AB Jr, Abramovits W, Zeichner J, Gold MH, Kirsner RS, Shull TF, Crowe AW, Jaracz E, Hanifin JM; Tacrolimus Ointment Study Group. Intermittent therapy for flare prevention and long-term disease control in stabilized atopic dermatitis: a randomized comparison of 3-times-weekly applications of tacrolimus ointment versus vehicle. J Am Acad Dermatol. 2008 Jun;58(6):990-9. doi: 10.1016/j.jaad.2008.02.008. Epub 2008 Mar 21.
PubMed 18359127Paller AS, Eichenfield LF, Kirsner RS, Shull T, Jaracz E, Simpson EL; US Tacrolimus Ointment Study Group. Three times weekly tacrolimus ointment reduces relapse in stabilized atopic dermatitis: a new paradigm for use. Pediatrics. 2008 Dec;122(6):e1210-8. doi: 10.1542/peds.2008-1343. Epub 2008 Nov 17.
PubMed 19015204
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study to Assess the Impact of Topical Corticosteroids on the Safety and Efficacy of Protopic Ointment in the Short-Term Treatment of Atopic Dermatitis and to Assess Protopic in the Long-term Management of Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00106496
- Acronym / sponsor ID
- 20-04-002
- Conditions
- Dermatitis, Atopic
- Keywords
- Treatment Effectiveness, Treatment Efficacy, Immunomodulator, Topical, Tacrolimus, Topical, Dermatitis, Atopic, Eczema, Atopic, Atopic Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 28 Mar 2005 (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 purpose of the study is to determine the impact of topical corticosteroids on the safety and effectiveness of Protopic Ointment in the short-term treatment of moderate to severe Atopic Dermatitis and to compare the safety and effectiveness of Protopic Ointment to placebo in the long-term management of Atopic Dermatitis
Detailed description
Study includes an interim short-term, open label period. Patients could also receive a second course of open label treatment dependent on disease exacerbation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1A | Experimental | Drug: Protopic |
| 1B | Active comparator | Drug: Corticosteroid |
| 2 | Experimental | Drug: ProtopicOpen label |
| 3A | Experimental | Drug: Protopic |
| 3B | Placebo comparator | Drug: placebo |
| 4 | Experimental | Drug: ProtopicOpen label |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient must have Atopic Dermatitis
- Patient must be at least 2 years of age
Key exclusion criteria (1 listed)
- Patient is pregnant or breast feeding an infant
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 |
|---|---|---|
| ProtopicAlso: tacrolimus ointment, FK506 ointmenttopical | Drug | 1A, 2, 3A, 4 |
| Corticosteroidtopical | Drug | 1B |
| placebotopical | Drug | 3B |
Primary outcome
percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatment
Time frame: 2 weeks
1 secondary outcome
Percentage of patients reporting cutaneous adverse events overall
Time frame: Day 4 through end of study
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 18 Sep 2014.
- Background: PubMed 18359127Breneman D, Fleischer AB Jr, Abramovits W, Zeichner J, Gold MH, Kirsner RS, Shull TF, Crowe AW, Jaracz E, Hanifin JM; Tacrolimus Ointment Study Group. Intermittent therapy for flare prevention and long-term disease control in stabilized atopic dermatitis: a randomized comparison of 3-times-weekly applications of tacrolimus ointment versus vehicle. J Am Acad Dermatol. 2008 Jun;58(6):990-9. doi: 10.1016/j.jaad.2008.02.008. Epub 2008 Mar 21.
- Background: PubMed 19015204Paller AS, Eichenfield LF, Kirsner RS, Shull T, Jaracz E, Simpson EL; US Tacrolimus Ointment Study Group. Three times weekly tacrolimus ointment reduces relapse in stabilized atopic dermatitis: a new paradigm for use. Pediatrics. 2008 Dec;122(6):e1210-8. doi: 10.1542/peds.2008-1343. Epub 2008 Nov 17.
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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.
Use Central Contact study director
Astellas Pharma US, Inc.
24 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 Protopic and Corticosteroid in people with Dermatitis, Atopic, run by Astellas Pharma Inc at 24 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 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 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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. 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 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?
percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatment (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00106496, which also lists 2 linked publications.
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 Sep 2014; AzTrials last refreshed its copy on 1 Nov 2026.