Back to resultsProtopic Ointment in Children Atopic Eczema
Primary Purpose
Dermatitis, Atopic
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Tacrolimus 0.03%
Fluticasone 0.005%
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Dermatitis, Atopic, Dermatologic Agents, Topical Drug Administration, Tacrolimus, Calcineurin, Corticosteroid, Fluticasone propionate, Child
Eligibility Criteria
Inclusion Criteria:
- Children with moderate to severe atopic dermatitis (Rajka & Langeland score greater than or equal to 4.5) and who had responded insufficiently to conventional therapies
- Female patients of childbearing age: effective means of contraception throughout the period of the study and for four weeks following the end of the study
- Informed consent
- Therapeutic washout for atopic dermatitis treatments
Exclusion Criteria:
- Genetic epidermal barrier defect, such as Netherton's syndrome, or suffering from erythroderma
- Any female patients who were pregnant or breast-feeding
- Clinical infection due to the VZV virus (varicella, zona), HSV1-2 viruses (herpes), verruca vulgaris or molluscum contagiosum
- Superinfected eczema
- Known hypersensitivity to macrolides or to any other excipient in tacrolimus ointment
- Known hypersensitivity to one of the agents contained in the fluticasone 0.005% ointment preparation
- Ulcerated lesions, of whatever type
- Moderate to severe acne or rosacea
- Patients participating at the same time in another clinical study or who have participated in another clinical study within 28 days of the start of this study
- substance abuse (including that of drugs and alcohol) or mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up
- Known serologically proven HIV positivity
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients presenting at the week 3 visit (day 21) with an improvement of at least 60% in their modified Eczema Area and Severity Index (mEASI) in comparison to day 1
Secondary Outcome Measures
mEASI and EASI scores at each visit and percentage change with respect to day 1
Global assessment of clinical response by the physician at each visit after day 1
Global assessment of clinical response by the patient/parents at each visit after day 1
All clinical signs, including sleep quality, severity of pruritus and body surface area affected at each visit
Compliance with the treatment assessed from the patient's diary
Patient's quality of life assessed at day 1 and day 21
Incidence of adverse events during the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00689832
Brief Title
Protopic Ointment in Children Atopic Eczema
Official Title
Comparative, Multicentre, Randomised, Double-blind Study to Assess the Efficacy of Tacrolimus 0.03% Ointment Versus Fluticasone 0.005% Ointment in Children Aged 2 Years or Over Suffering From Moderate to Severe Atopic Dermatitis.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Children with atopic eczema and a poor response to topical corticosteroid applied either Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more weeks once a day if needed.
Detailed Description
Treatments were to be applied twice daily until clearance, for a maximum of 3 weeks and then, in case of uncleared residual lesions, once daily for up to 3 further weeks. In the event of a flare-up the treatment was to be resumed twice a day until the end of the study.
Statistical methods: An interim analysis was performed on 30% of the planned total sample size, i.e. 140 included patients who had completed the study, to reassess the assumptions made during the planning phase.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Dermatitis, Atopic, Dermatologic Agents, Topical Drug Administration, Tacrolimus, Calcineurin, Corticosteroid, Fluticasone propionate, Child
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
487 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tacrolimus 0.03%
Other Intervention Name(s)
Protopic® 0.03%
Intervention Description
ointment
Intervention Type
Drug
Intervention Name(s)
Fluticasone 0.005%
Other Intervention Name(s)
Flixovate® 0.005%
Intervention Description
ointment
Primary Outcome Measure Information:
Title
Percentage of patients presenting at the week 3 visit (day 21) with an improvement of at least 60% in their modified Eczema Area and Severity Index (mEASI) in comparison to day 1
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
mEASI and EASI scores at each visit and percentage change with respect to day 1
Time Frame
1 week and 3 weeks
Title
Global assessment of clinical response by the physician at each visit after day 1
Time Frame
1 week and 3 weeks
Title
Global assessment of clinical response by the patient/parents at each visit after day 1
Time Frame
1 week and 3 weeks
Title
All clinical signs, including sleep quality, severity of pruritus and body surface area affected at each visit
Time Frame
1 week and 3 weeks
Title
Compliance with the treatment assessed from the patient's diary
Time Frame
1 week and 3 weeks
Title
Patient's quality of life assessed at day 1 and day 21
Time Frame
3 weeks
Title
Incidence of adverse events during the study
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children with moderate to severe atopic dermatitis (Rajka & Langeland score greater than or equal to 4.5) and who had responded insufficiently to conventional therapies
Female patients of childbearing age: effective means of contraception throughout the period of the study and for four weeks following the end of the study
Informed consent
Therapeutic washout for atopic dermatitis treatments
Exclusion Criteria:
Genetic epidermal barrier defect, such as Netherton's syndrome, or suffering from erythroderma
Any female patients who were pregnant or breast-feeding
Clinical infection due to the VZV virus (varicella, zona), HSV1-2 viruses (herpes), verruca vulgaris or molluscum contagiosum
Superinfected eczema
Known hypersensitivity to macrolides or to any other excipient in tacrolimus ointment
Known hypersensitivity to one of the agents contained in the fluticasone 0.005% ointment preparation
Ulcerated lesions, of whatever type
Moderate to severe acne or rosacea
Patients participating at the same time in another clinical study or who have participated in another clinical study within 28 days of the start of this study
substance abuse (including that of drugs and alcohol) or mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up
Known serologically proven HIV positivity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Director
Facility Information:
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140567 in the JapicCTI-RNo. field
Learn more about this trial
Protopic Ointment in Children Atopic Eczema
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