Protopic Ointment in Adult Atopic Eczema of the Face

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00690105
First received: June 2, 2008
Last updated: December 4, 2008
Last verified: December 2008
  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 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%
ointment
Other Name: Protopic® 0.1%
Active Comparator: B Drug: fluticasone 0.005 %
ointment
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.

  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

No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov 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: December 4, 2008
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
Tacrolimus
Calcineurin
Corticosteroid
Fluticasone propionate
Face

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

ClinicalTrials.gov processed this record on April 14, 2014