NCT00925730CompletedPhase 4
Non-comparative Open-label Study to Investigate the Efficacy, Safety and Systemic Exposure of Pimecrolimus in Adult and Pediatric Patients With Moderate to Severe Atopic Dermatitis Treated Topically for 8.5 Days With Pimecrolimus Cream 1% Under Occlusion
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Pimecrolimus blood concentration
Study Overview
Brief Summary
This study will access the degree to which pimecrolimus is absorbed from pimecrolimus cream 1% into the blood when applied repeatedly under occlusion (i.e. areas treated wrapped in a plastic film) over 8 days in patients with moderate to severe atopic eczema.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients 2 - 18 years of age
- •Patients with a diagnosis of moderate to severe atopic dermatitis, assessed by a score ≥ 3 at the Investigator's Global Assessment. AD to involve at least 30% of their body surface area as determined by the rule of nine or the Lund and Browder chart.
Exclusion Criteria
- •Erythrodermic patients with Netherton's syndrome
- •Patients with known serious adverse reactions or hypersensitivity to any of the excipients of the study medication
- •Patients with a history of cancer, skin malignancy or lymphoproliferative disorders or of immunocompromise, including a positive HIV (ELISA and Western blot), Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
- •Other protocol-defined inclusion/exclusion criteria may apply
Arms & Interventions
Pimecrolimus cream 1%
Experimental
Pimecrolimus
Intervention: Pimecrolimus (Drug)
Outcomes
Primary Outcomes
Pimecrolimus blood concentration
Time Frame: Days 1, 9, 16
Secondary Outcomes
- Efficacy as assessed by the Eczema Area and Severity Index and the Investigators Global Assessment of disease severity. Efficacy outcomes were of an exploratory nature in this study.(Days 1, 9, 16)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate TabletsHealthy VolunteersNCT01055691AstraZeneca120
Completed
Phase 1
A Phase I Bioavailability and Pharmacokinetic Study of [14C]-Ipatasertib Single Oral and Intravenous Doses in Healthy Male SubjectsHealthy VolunteerNCT02390492Genentech, Inc.8
Completed
Phase 1
A Study to Evaluate the Relative Bioavailability, Food Effect and Effect of Ketoconazole on the Rate and Extent of Absorption of Solid Dosage Formulation(s) of JNJ-40411813HealthyNCT01932320Johnson & Johnson Pharmaceutical Research & Development, L.L.C.36
Completed
Not Applicable
An open-label study to assess the absorption, distribution, metabolism and excretion, including the mass balance of [14C] labeled BIA 5-1058 and metabolites following a single oral dose administration in healthy male subjects<br>cardiovascular diseases1008220610047066NL-OMON45578Bial Portela & Ca.8
Terminated
Phase 1
A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.Ulcerative ColitisNCT00254618Warner Chilcott34