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NCT01806662 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Ustekinumab for Subjects With Chronic Atopic Dermatitis
A Phase 2 study, sponsored by Rockefeller University.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT01806662 is a Phase 2 study that has completed, run by Rockefeller University. The registered enrollment target is 32 participants.
The verdict
NCT01806662, a Phase 2 study, has completed, sponsored by Rockefeller University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
Atopic dermatitis (AD) is a chronic disease associated with intense itching, which affects most aspects of everyday life in the majority of patients. Acute inflammation and extensor/facial involvement is common in infants, whereas chronic inflammation increases in prevalence with age, as do localization to flexures. AD has a complex background characterized by immune activation, increased epidermal thickness in chronic diseased skin, and defective barrier function. In normal, healthy skin, the outer layer of the epidermis, the stratum corneum is made up flattened dead cells called corneocytes held together by a mixture of lipids and proteins. The stratum corneum and, in particular, the lipid layer are vital in providing a natural barrier function that locks water inside the skin and keeps allergens and irritants out. In people with AD, the barrier function is defective, which leads to dry skin. As the skin dries out, it cracks allowing allergens and irritants to penetrate. Mild AD can be controlled with emollients and topical medications. However, moderate to severe AD is extremely difficult to control and requires systemic treatment that is often unsatisfactory due to impracticality and lack of effectiveness. Only three therapeutic options exist for moderate to severe AD, including: 1) oral steroids 2) cyclosporine A (CsA), that is not widely used in the US as it is not FDA approved for AD and 3) ultraviolet phototherapy. Oral steroids and CsA treatments have major side effects and UV radiation therapy is highly inconvenient for patients. Several biologic medications, such as TNF-alpha inhibitors, are effective, convenient, and relatively safe therapies for psoriasis, but have thus far not shown efficacy in AD. Ustekinumab is a unique biologic medication that may specifically target AD. The investigators study will determine whether there is a reversal of the skin thickness and the immune pathways involved in the disease during treatment with Ustekinumab and what
Interventions
- DRUG Ustekinumab
- OTHER Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2013-03 |
| Est. Completion | 2015-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01806662
The ClinicalTrials.gov registry entry for NCT01806662 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rockefeller University, which has 117 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ustekinumab is the first listed.
NCT01806662 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01806662 about?
NCT01806662 is a clinical study titled "Pilot Study of Ustekinumab for Subjects With Chronic Atopic Dermatitis". Atopic dermatitis (AD) is a chronic disease associated with intense itching, which affects most aspects of everyday life in the majority of patients. Acute inflammation and extensor/facial involvement is common in infants, whereas chronic inflammation increases in prevalence with age, as do localiza...
What is the current status of trial NCT01806662?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2013-03. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01806662?
The interventions under investigation include: Ustekinumab (DRUG), Placebo (OTHER).
Who is sponsoring clinical trial NCT01806662?
This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.
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