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Completed

NCT Number: NCT00689832

Protopic Ointment in Children Atopic Eczema

Children with 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.

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Paris, 75015, France

About this study

Treatments were to be applied twice daily 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.

Statistical methods: An interim analysis was performed on 30% of the planned total sample size, i.e. 140 included patients who had completed the study, to reassess the assumptions made during the planning phase.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children with moderate to severe atopic dermatitis (Rajka & Langeland score greater than or equal to 4.5) and who had responded insufficiently to conventional therapies
  • 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
  • Any female patients who were pregnant or breast-feeding
  • 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 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 participating at the same time in another clinical study or who have participated in another clinical study within 28 days of the start of this study
  • substance abuse (including that of drugs and alcohol) or mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up
  • Known serologically proven HIV positivity

Treatment and study plan

Tacrolimus 0.03%

Drug

ointment

Other names: Protopic® 0.03%

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 modified Eczema Area and Severity Index (mEASI) in comparison to day 1

    Time frame: 3 weeks

Secondary outcomes

  1. mEASI and EASI scores at each visit and percentage change with respect to day 1

    Time frame: 1 week and 3 weeks

  2. Global assessment of clinical response by the physician at each visit after day 1

    Time frame: 1 week and 3 weeks

  3. Global assessment of clinical response by the patient/parents at each visit after day 1

    Time frame: 1 week and 3 weeks

  4. All clinical signs, including sleep quality, severity of pruritus and body surface area affected at each visit

    Time frame: 1 week and 3 weeks

  5. Compliance with the treatment assessed from the patient's diary

    Time frame: 1 week and 3 weeks

  6. Patient's quality of life assessed at day 1 and day 21

    Time frame: 3 weeks

  7. Incidence of adverse events during the study

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Comparative, Multicentre, Randomised, Double-blind Study to Assess the Efficacy of Tacrolimus 0.03% Ointment Versus Fluticasone 0.005% Ointment in Children Aged 2 Years or Over Suffering From Moderate to Severe Atopic Dermatitis.

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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