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Quality of Life Study in Adults With Facial Eczema

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Pimecrolimus
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Randomised, Placebo-controlled, Elidel, Quality of Life, Atopic Eczema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males and females aged 18 years or older Active Moderate Facial AE at baseline (Facial IGA score of 3), within 3 days of a deterioration in symptoms that necessitates further treatment. Diagnosis of AE fulfilling the diagnostic criteria of Williams (Williams, et al. 1994) outlined below: *Must have an itchy skin condition plus 3 or more of the following 5 items listed below: History of involvement of the skin creases such as folds or elbows, behind the knees, fronts of ankles or around the neck; A personal history of asthma or hay fever; A history of a general dry skin in the last year; Visible flexural edema; Onset under the age of 2 Pruritus score of 2 or above at baseline Patients in whom further use of TCS is clinically inappropriate due to: burning, stinging, allergic reaction or other adverse event that prevents the patient from using topical corticosteroids to successfully treat an AE flare on the face; presence of rosacea, telangiectasia, skin atrophy or glaucoma as a result of topical corticosteroid usage on the face; presence of AE on the eyelids Or patients where previous treatment has been unsatisfactory and who would prefer to try an alternative treatment option. Patients who have been informed of the study procedures and have signed the informed consent form approved for the study. (Informed consent should be signed as instructed in ICH-GCP and local regulations). Exclusion Criteria: At baseline and throughout the study, females of childbearing potential: Who are pregnant or breast-feeding Who are menstruating, capable of becoming pregnant, and not practicing a medically approved method of contraception during and up to at least 4 weeks after the end of study treatment. A negative pregnancy test (urine) for all females of childbearing potential is required at the screening visit. 'Medically approved' contraception may include abstinence at the discretion of the investigator At baseline and throughout the study, all patients: Who have received phototherapy (e.g. UVB, UVA) or systemic therapy (e.g. immunosuppressants, cytostatics) known or suspected to have an effect on AE within 1 month of Visit 1 (baseline) Who have received systemic corticosteroids (e.g. oral, intravenous, intra-articular, rectal) within 1 month of Visit 1. Patients on a stable maintenance dose of inhaled corticosteroids may participate Who have a known or suspected contact allergic dermatitis Who have received systemic antibiotics within 2 weeks prior to Visit 1. Who have used oral or topical antihistamines for the treatment of Pruritus within 2 weeks prior to visit 1 Who have applied topical therapy (e.g. tar, topical corticosteroids, pimecrolimus or tacrolimus within 2 weeks prior to Screening Who have used potent or very potent TCS within 4 weeks prior to Visit 1. Who are immunocompromised (e.g. lymphoma, HIV infection/AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease Who have a history of poor or no clinical response, or hypersensitivity to topical pimecrolimus cream 1%. Who have concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the evaluation. Who have active bacterial (e.g. impetigo), viral (e.g. chicken pox, herpes simplex) or fungal infections (e.g. tinea corporis, intertriginosa) Who have received any investigational drugs within 8 weeks of visit 1, or plan to use any other investigational drugs during the course of this study Who, in the opinion of the investigator, are known to be unreliable, who are non-compliant with medical treatment, or are known to miss appointments Who have abuse problems, mental dysfunction or other factors limiting their ability to cooperate fully in study-related procedures

Sites / Locations

  • This study is not being conducted in the United States

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Pimecrolimus

Vehicle

Outcomes

Primary Outcome Measures

Change in quality of life score between baseline (study start) and week 4.

Secondary Outcome Measures

Changes in patient's quality of life from baseline (study start) to 1 and 2 weeks after the beginning of treatment.
Between-treatment comparison of Investigator's Global Assessment (IGA) (face only); Patient's Global Assessment (face only); Pruritus (itch) Severity Assessment (face only).
Time from baseline (study start) to clearance of eczema.

Full Information

First Posted
July 8, 2005
Last Updated
January 15, 2008
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00120302
Brief Title
Quality of Life Study in Adults With Facial Eczema
Official Title
Quality of Life Study in Adults With Facial Eczema
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
This study is not being conducted in the US. The study consists of a 4 week double blind treatment period. All patients meeting the inclusion/exclusion criteria will enter the study at day 0 and be randomized into either pimecrolimus cream 1% or vehicle treatment groups in a 1:1 ratio. Patients will return to clinic on days 7,14 and 28 for assessments of disease severity. Patients who experience an unsatisfactory therapeutic effect, will attend an unscheduled visit and be withdrawn from the study. Assessments of eligibility include an Investigator's Global Assessment and Pruritus score. Treatment history will be collected at baseline and Quality of Life Questionnaires will be carried out at every visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Randomised, Placebo-controlled, Elidel, Quality of Life, Atopic Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Pimecrolimus
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Vehicle
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus
Other Intervention Name(s)
Elidel
Intervention Description
Pimecrolimus cream 1 %
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching vehicle cream
Primary Outcome Measure Information:
Title
Change in quality of life score between baseline (study start) and week 4.
Secondary Outcome Measure Information:
Title
Changes in patient's quality of life from baseline (study start) to 1 and 2 weeks after the beginning of treatment.
Title
Between-treatment comparison of Investigator's Global Assessment (IGA) (face only); Patient's Global Assessment (face only); Pruritus (itch) Severity Assessment (face only).
Title
Time from baseline (study start) to clearance of eczema.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females aged 18 years or older Active Moderate Facial AE at baseline (Facial IGA score of 3), within 3 days of a deterioration in symptoms that necessitates further treatment. Diagnosis of AE fulfilling the diagnostic criteria of Williams (Williams, et al. 1994) outlined below: *Must have an itchy skin condition plus 3 or more of the following 5 items listed below: History of involvement of the skin creases such as folds or elbows, behind the knees, fronts of ankles or around the neck; A personal history of asthma or hay fever; A history of a general dry skin in the last year; Visible flexural edema; Onset under the age of 2 Pruritus score of 2 or above at baseline Patients in whom further use of TCS is clinically inappropriate due to: burning, stinging, allergic reaction or other adverse event that prevents the patient from using topical corticosteroids to successfully treat an AE flare on the face; presence of rosacea, telangiectasia, skin atrophy or glaucoma as a result of topical corticosteroid usage on the face; presence of AE on the eyelids Or patients where previous treatment has been unsatisfactory and who would prefer to try an alternative treatment option. Patients who have been informed of the study procedures and have signed the informed consent form approved for the study. (Informed consent should be signed as instructed in ICH-GCP and local regulations). Exclusion Criteria: At baseline and throughout the study, females of childbearing potential: Who are pregnant or breast-feeding Who are menstruating, capable of becoming pregnant, and not practicing a medically approved method of contraception during and up to at least 4 weeks after the end of study treatment. A negative pregnancy test (urine) for all females of childbearing potential is required at the screening visit. 'Medically approved' contraception may include abstinence at the discretion of the investigator At baseline and throughout the study, all patients: Who have received phototherapy (e.g. UVB, UVA) or systemic therapy (e.g. immunosuppressants, cytostatics) known or suspected to have an effect on AE within 1 month of Visit 1 (baseline) Who have received systemic corticosteroids (e.g. oral, intravenous, intra-articular, rectal) within 1 month of Visit 1. Patients on a stable maintenance dose of inhaled corticosteroids may participate Who have a known or suspected contact allergic dermatitis Who have received systemic antibiotics within 2 weeks prior to Visit 1. Who have used oral or topical antihistamines for the treatment of Pruritus within 2 weeks prior to visit 1 Who have applied topical therapy (e.g. tar, topical corticosteroids, pimecrolimus or tacrolimus within 2 weeks prior to Screening Who have used potent or very potent TCS within 4 weeks prior to Visit 1. Who are immunocompromised (e.g. lymphoma, HIV infection/AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease Who have a history of poor or no clinical response, or hypersensitivity to topical pimecrolimus cream 1%. Who have concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the evaluation. Who have active bacterial (e.g. impetigo), viral (e.g. chicken pox, herpes simplex) or fungal infections (e.g. tinea corporis, intertriginosa) Who have received any investigational drugs within 8 weeks of visit 1, or plan to use any other investigational drugs during the course of this study Who, in the opinion of the investigator, are known to be unreliable, who are non-compliant with medical treatment, or are known to miss appointments Who have abuse problems, mental dysfunction or other factors limiting their ability to cooperate fully in study-related procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
This study is not being conducted in the United States
City
Novartis Pharmaceuticals UK, Frimley
Country
United Kingdom

12. IPD Sharing Statement

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Quality of Life Study in Adults With Facial Eczema

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