Protopic Ointment in Adult Atopic Eczema of the Face

August 28, 2014 updated by: Astellas Pharma Inc

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

577

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Drug: fluticasone 0.005 %
ointment
Other Names:
  • Flixovate® 0.005%
Experimental: A
Drug: tacrolimus 0.1%
ointment
Other Names:
  • Protopic® 0.1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients no longer presenting with 'facial' erythema at day 7 and day 21
Time Frame: 1 week and 3 weeks
1 week and 3 weeks
Assessment of facial pruritus at day 1, day 7 and day 21
Time Frame: 1 week and 3 weeks
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
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
1 week and 3 weeks
Patient's quality of life at day 1 and day 21
Time Frame: 1 week and 3 weeks
1 week and 3 weeks
mLEASI score values at day 7 and day 21
Time Frame: 1 week and 3 weeks
1 week and 3 weeks
Physician's assessment of individual signs
Time Frame: 1 week and 3 weeks
1 week and 3 weeks
Quality of sleep at day 1, day 7 and day 21
Time Frame: 1 week and 3 weeks
1 week and 3 weeks
Affected surface area assessment at day 1, day 7 and day 21
Time Frame: 1 week and 3 weeks
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
3 weeks
Incidences of adverse events during the study period
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

June 2, 2008

First Submitted That Met QC Criteria

June 3, 2008

First Posted (Estimate)

June 4, 2008

Study Record Updates

Last Update Posted (Estimate)

September 1, 2014

Last Update Submitted That Met QC Criteria

August 28, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FG-506-06-FR-04
  • EUDRACT #: 2004-002477-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dermatitis, Atopic

Clinical Trials on tacrolimus 0.1%

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe