Pimecrolimus Cream 1% in Patients (18 Years of Age and Over) With Mild to Moderate Chronic Hand Dermatitis
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00226707
First received: September 26, 2005
Last updated: February 13, 2008
Last verified: February 2008
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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
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 Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Dermatologic Agents Immunosuppressive Agents Immunologic Factors Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013