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Protopic Ointment in Adult Atopic Eczema of the Face

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

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 Intervention Phase
Dermatitis, Atopic
Drug: tacrolimus 0.1%
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, 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.

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 local mEASI score (mLEASI) compared to Baseline (day 1). [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

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

Enrollment: 577
Study Start Date: February 2004
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: tacrolimus 0.1%
Other Name: Protopic® 0.1%
Active Comparator: B Drug: fluticasone 0.005 %
Other Name: Flixovate® 0.005%

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.


Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00690105

Nice, France, 06202
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Central Contact Astellas Pharma Europe B.V.
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc Identifier: NCT00690105     History of Changes
Other Study ID Numbers: FG-506-06-FR-04, EUDRACT #: 2004-002477-23
Study First Received: June 2, 2008
Last Updated: August 28, 2014
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
Tunisia: Office of Pharmacies and Medicines
Morocco: Ministry of Public Health
Romania: National Medicines Agency

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

Additional relevant MeSH terms:
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on November 19, 2014