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

Chronic Hand Dermatitis Clinical Trial

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%

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00226707
• Other study ID #: CASM981M2301
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2005
• Last updated: February 13, 2008
• Start date: July 2004
• Est. completion date: March 2005

Study information

• Verified date: February 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 652
• Est. completion date: March 2005
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hand Dermatitis
• Dermatitis
• Eczema

Intervention

Drug:
• Pimecrolimus Cream 1%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigators Global Assessment (IGA) of the target hand at day 43 or at time of early discontinuation.
Secondary	IGA of the non-target hand
Secondary	Itching/burning assessment for the target and non-target hand
Secondary	Non-key signs of hand dermatitis (vesiculation, oozing/crusts, edema/population, lichenification) at each study visit
Secondary	Work productivity and activity impairment questionnaire