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Protopic Ointment in Adult Atopic Eczema of the Face

This study has been completed.

Sponsored by: Astellas Pharma Inc
Information provided by: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00690105
  Purpose

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 IV

MedlinePlus related topics:   Eczema   

ChemIDplus related topics:   Tacrolimus    Corticosteroids    Fluticasone propionate    Fluticasone    Tacrolimus anhydrous   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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.

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:   568
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
A: Experimental Drug: tacrolimus 0.1%
ointment
B: Active Comparator Drug: fluticasone 0.005 %
ointment

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.

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690105

Locations
France
      Nice, France, 06202

Sponsors and Collaborators
Astellas Pharma Inc

Investigators
Study Director:     Central Contact     Astellas Pharma Europe BV    
  More Information

Responsible Party:   Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:   FG-506-06-FR-04, EUDRACT #: 2004-002477-23
First Received:   June 2, 2008
Last Updated:   June 3, 2008
ClinicalTrials.gov Identifier:   NCT00690105
Health Authority:   France: Afssaps - French Health Products Safety Agency;   Belgium: Federal Agency for Medicinal Products and Health Products;   Finland: National Agency for Medicines;   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  
Tacrolimus  
Calcineurin
Corticosteroid
Fluticasone propionate
Face

Study placed in the following topic categories:
Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Facies
Hypersensitivity, Immediate
Fluticasone
Skin Diseases, Eczematous
Tacrolimus
Eczema
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Anti-Allergic Agents
Immunosuppressive Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 04, 2008




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