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Protopic Ointment in Children Atopic Eczema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00689832
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : September 1, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: Tacrolimus 0.03% Drug: Fluticasone 0.005% Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 487 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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.
Study Start Date : February 2004
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: A Drug: Tacrolimus 0.03%
Other Name: Protopic® 0.03%

Active Comparator: B Drug: Fluticasone 0.005%
Other Name: Flixovate® 0.005%

Primary Outcome Measures :
  1. 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 :
  1. mEASI and EASI scores at each visit and percentage change with respect to day 1 [ Time Frame: 1 week and 3 weeks ]
  2. Global assessment of clinical response by the physician at each visit after day 1 [ Time Frame: 1 week and 3 weeks ]
  3. Global assessment of clinical response by the patient/parents at each visit after day 1 [ Time Frame: 1 week and 3 weeks ]
  4. All clinical signs, including sleep quality, severity of pruritus and body surface area affected at each visit [ Time Frame: 1 week and 3 weeks ]
  5. Compliance with the treatment assessed from the patient's diary [ Time Frame: 1 week and 3 weeks ]
  6. Patient's quality of life assessed at day 1 and day 21 [ Time Frame: 3 weeks ]
  7. Incidence of adverse events during the study [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00689832

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

Additional Information:
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Responsible Party: Astellas Pharma Inc Identifier: NCT00689832    
Other Study ID Numbers: FG-506-06-FR-05
EUDRACT #:2004-002478-47
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014
Keywords provided by Astellas Pharma Inc:
Dermatitis, Atopic
Dermatologic Agents
Topical Drug Administration
Fluticasone propionate
Additional relevant MeSH terms:
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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