Protopic Ointment in Children Atopic Eczema
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00689832
First received: June 2, 2008
Last updated: December 4, 2008
Last verified: December 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dermatitis, Atopic |
Drug: Tacrolimus 0.03% Drug: Fluticasone 0.005% |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
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 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- mEASI and EASI scores at each visit and percentage change with respect to day 1 [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
- Global assessment of clinical response by the physician at each visit after day 1 [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
- Global assessment of clinical response by the patient/parents at each visit after day 1 [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
- All clinical signs, including sleep quality, severity of pruritus and body surface area affected at each visit [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
- Compliance with the treatment assessed from the patient's diary [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
- Patient's quality of life assessed at day 1 and day 21 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- Incidence of adverse events during the study [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 487 |
| Study Start Date: | February 2004 |
| Study Completion Date: | August 2005 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: Tacrolimus 0.03%
ointment
Other Name: Protopic® 0.03%
|
| Active Comparator: B |
Drug: Fluticasone 0.005%
ointment
Other Name: Flixovate® 0.005%
|
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.
Eligibility| Ages Eligible for Study: | 2 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Disclosure Office Europe, Astellas Pharma Europe BV |
| ClinicalTrials.gov Identifier: | NCT00689832 History of Changes |
| Other Study ID Numbers: | FG-506-06-FR-05, EUDRACT #:2004-002478-47 |
| Study First Received: | June 2, 2008 |
| Last Updated: | December 4, 2008 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Belgium: Federal Agency for Medicinal Products and Health Products Finland: Finnish Medicines Agency Morocco: Ministry of Public Health Tunisia: Office of Pharmacies and Medicines |
Keywords provided by Astellas Pharma Inc:
|
Dermatitis, Atopic Dermatologic Agents Topical Drug Administration Tacrolimus |
Calcineurin Corticosteroid Fluticasone propionate Child |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone Dermatologic Agents Tacrolimus |
Therapeutic Uses Pharmacologic Actions Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Anti-Allergic Agents Anti-Inflammatory Agents Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 22, 2013