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Protopic Ointment in Adult Atopic Eczema of the Face

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: NCT00690105
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : September 1, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
Patients with facial 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 or change for the other ointment.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: tacrolimus 0.1% Drug: fluticasone 0.005 % Phase 4

Detailed Description:
Treatments were to be applied twice daily over all lesions on the face (except for the eyelids) 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 577 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparative, Multicentre, Randomized, Double-blind Study to Assess the Efficacy of Tacrolimus 0.1% Ointment Versus Fluticasone 0.005% Ointment in Adult Patients Suffering From Moderate to Severe Atopic Dermatitis and Presenting With So-called 'Red Face' Lesions of the Head and Neck.
Study Start Date : February 2004
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: A Drug: tacrolimus 0.1%
Other Name: Protopic® 0.1%

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 local mEASI score (mLEASI) compared to Baseline (day 1). [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Percentage of patients no longer presenting with 'facial' erythema at day 7 and day 21 [ Time Frame: 1 week and 3 weeks ]
  2. Assessment of facial pruritus at day 1, day 7 and day 21 [ Time Frame: 1 week and 3 weeks ]
  3. Global assessment of clinical response on the 'face' by the physician at day 7 and day 21 [ Time Frame: 1 week and 3 weeks ]
  4. Global assessment of clinical response on the 'face' by the patient at day 7 and day 21 [ Time Frame: 1 week and 3 weeks ]
  5. Patient's quality of life at day 1 and day 21 [ Time Frame: 1 week and 3 weeks ]
  6. mLEASI score values at day 7 and day 21 [ Time Frame: 1 week and 3 weeks ]
  7. Physician's assessment of individual signs [ Time Frame: 1 week and 3 weeks ]
  8. Quality of sleep at day 1, day 7 and day 21 [ Time Frame: 1 week and 3 weeks ]
  9. Affected surface area assessment at day 1, day 7 and day 21 [ Time Frame: 1 week and 3 weeks ]
  10. Number of patients using the ointment from the other group to treat facial lesions after day 21 [ Time Frame: 3 weeks ]
  11. Incidences of adverse events during the study period [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Moderate to severe AD (Rajka & Langeland score) with lesions to the head and neck defined as 'red face' or 'facial eczema': erythema affecting at least 10% of the surface of the 'face' (head, neck, chest, nape of neck), due to long-term AD
  • At least two flare-ups of 'facial' eczema during the 12 months prior to inclusion and, in the investigator's opinion, conventional treatment had proved ineffective or poorly tolerated
  • 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
  • Seborrheic dermatitis or contact dermatitis affecting the 'face', or any other facial erythema of non-atopic origin
  • 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 0.1% 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 who participated at the same time in another clinical study or who had participated in another clinical study within 28 days prior to inclusion in the study
  • Any type of substance abuse (including that of drugs and alcohol) or any mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up
  • 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): NCT00690105

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Nice, France, 06202
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: NCT00690105    
Other Study ID Numbers: FG-506-06-FR-04
EUDRACT #: 2004-002477-23
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