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Completed

NCT Number: NCT00690105

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.

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Disease Attributes Facies Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nice, 06202, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tacrolimus 0.1%

Drug

ointment

Other names: Protopic® 0.1%

fluticasone 0.005 %

Drug

ointment

Other names: Flixovate® 0.005%

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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.

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jun 4, 2008
Registry last updated
Sep 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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