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
  Purpose

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.


Condition Intervention Phase
Chronic Hand Dermatitis
Drug: Pimecrolimus Cream 1%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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%

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Investigators Global Assessment (IGA) of the target hand at day 43 or at time of early discontinuation.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 652
Study Start Date: July 2004
Study Completion Date: March 2005
Intervention Details:
    Drug: Pimecrolimus Cream 1%
    Other Name: Elidel
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226707

Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Japan Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00226707     History of Changes
Other Study ID Numbers: CASM981M2301
Study First Received: September 26, 2005
Last Updated: February 13, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Chronic hand dermatitis, pimecrolimus, dermatitis

Additional relevant MeSH terms:
Dermatitis
Skin Diseases
Pimecrolimus
Tacrolimus
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014