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OpenTrials
Completed

NCT Number: NCT00226707

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pimecrolimus cream 1%

Drug

Other names: Elidel

Primary outcomes

  1. Investigators Global Assessment (IGA) of the target hand at day 43 or at time of early discontinuation.

Secondary outcomes

  1. IGA of the non-target hand

  2. Itching/burning assessment for the target and non-target hand

  3. Non-key signs of hand dermatitis (vesiculation, oozing/crusts, edema/population, lichenification) at each study visit

  4. Work productivity and activity impairment questionnaire

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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%

Important dates

Study start
2004
Study completion
2005
First posted
Sep 27, 2005
Registry last updated
Feb 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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