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Pimecrolimus Cream 1% in Patients (18 Years of Age and Over) With Mild to Moderate Chronic Hand Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00226707
First received: September 26, 2005
Last updated: February 13, 2008
Last verified: February 2008
History of Changes

September 26, 2005
February 13, 2008
July 2004
Not Provided
Investigators Global Assessment (IGA) of the target hand at day 43 or at time of early discontinuation.
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Complete list of historical versions of study NCT00226707 on ClinicalTrials.gov Archive Site
  • IGA of the non-target hand
  • Itching/burning assessment for the target and non-target hand
  • Non-key signs of hand dermatitis (vesiculation, oozing/crusts, edema/population, lichenification) at each study visit
  • Work productivity and activity impairment questionnaire
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Pimecrolimus Cream 1% in Patients (18 Years of Age and Over) With Mild to Moderate Chronic Hand Dermatitis
A 6-Week Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of Pimecrolimus Cream 1% in Patients With Mild-to-Moderate Chronic Hand Dermatitis Followed by a 6-Week Open-Label Phase to Assess the Safety of Pimecrolimus Cream 1%

Topical steroids are standard of care for Chronic Hand Dermatitis, but long-term use is associated with adverse effects. This study will assess the efficacy and safety of pimecrolimus cream 1% in patients with mild-to-moderate chronic hand dermatitis.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Chronic Hand Dermatitis
Drug: Pimecrolimus Cream 1%
Other Name: Elidel
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
652
March 2005
Not Provided

Inclusion Criteria:

  • - Patients who are outpatients at baseline (Day 1)
  • Patients must be 18 years of age or above
  • Patients must have chronic hand dermatitis based upon clinical diagnosis with mild to moderate dermatitis of the target hand at baseline, as defined by an Investigator's Global Assessment score of 2 (mild) or 3 (moderate).
  • Patients must have been informed of the study procedures and medication and have given their written informed consent

Exclusion Criteria:

  • - Women who are pregnant or who are breast-feeding.
  • Patients who have received systemic corticosteroids (i.e., oral, intravenous, intra-articular, rectal, intramuscular) within one month prior to first application of study medication.
  • Patients who have received phototherapy (e.g., UVB, PUVA) or systemic therapy (e.g., immunosuppressants, cytostatics) known or suspected to have an effect on hand dermatitis within at least one month prior to first application of study medication.
  • Patients who have received pimecrolimus cream 1% or tacrolimus ointment 0.1% or 0.03% within 14 days prior to first application of study medication.
  • Patients who were treated with topical therapy (e.g., tar, topical corticosteroids, Burrows solution soaks) known or suspected to have an effect on hand dermatitis within 7 days prior to first application of trial medication.

Other protocol-defined inclusion/exclusion criteria may apply.
Both
18 Years and older
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Contact information is only displayed when the study is recruiting subjects
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NCT00226707
CASM981M2301
Not Provided
External Affairs, Novartis
Novartis
Not Provided
Study Chair: Novartis Pharmaceuticals Japan Novartis Pharmaceuticals
Novartis
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP