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Protopic Ointment in Children Atopic Eczema

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: June 2, 2008
Last updated: August 28, 2014
Last verified: August 2014
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]

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 ]
  • Global assessment of clinical response by the physician at each visit after day 1 [ Time Frame: 1 week and 3 weeks ]
  • Global assessment of clinical response by the patient/parents at each visit after day 1 [ Time Frame: 1 week and 3 weeks ]
  • All clinical signs, including sleep quality, severity of pruritus and body surface area affected at each visit [ Time Frame: 1 week and 3 weeks ]
  • Compliance with the treatment assessed from the patient's diary [ Time Frame: 1 week and 3 weeks ]
  • Patient's quality of life assessed at day 1 and day 21 [ Time Frame: 3 weeks ]
  • Incidence of adverse events during the study [ Time Frame: 6 weeks ]

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%
Other Name: Protopic® 0.03%
Active Comparator: B Drug: Fluticasone 0.005%
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.


Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00689832

Paris, France, 75015
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Central Contact Astellas Pharma Europe B.V.
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc 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: August 28, 2014

Keywords provided by Astellas Pharma Inc:
Dermatitis, Atopic
Dermatologic Agents
Topical Drug Administration
Fluticasone propionate

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents processed this record on April 28, 2017