Protopic Ointment in Adult Atopic Eczema of the Face


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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2005

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.


  • Drug: tacrolimus 0.1%
    • ointment
  • Drug: fluticasone 0.005 %
    • ointment

Arms, Groups and Cohorts

  • Experimental: A
  • Active Comparator: B

Clinical Trial Outcome Measures

Primary 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

Secondary Measures

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

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 16 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Astellas Pharma Inc
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Central Contact, Study Director, Astellas Pharma Europe B.V.

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