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Protopic Ointment in Adult Atopic Eczema of the Face

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
tacrolimus 0.1%
fluticasone 0.005 %
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Dermatitis, Atopic, Dermatologic Agents, Topical Drug Administration, Tacrolimus, Calcineurin, Corticosteroid, Fluticasone propionate, Face

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

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).

Secondary Outcome Measures

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

Full Information

First Posted
June 2, 2008
Last Updated
August 28, 2014
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00690105
Brief Title
Protopic Ointment in Adult Atopic Eczema of the Face
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Dermatitis, Atopic, Dermatologic Agents, Topical Drug Administration, Tacrolimus, Calcineurin, Corticosteroid, Fluticasone propionate, Face

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
577 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
tacrolimus 0.1%
Other Intervention Name(s)
Protopic® 0.1%
Intervention Description
ointment
Intervention Type
Drug
Intervention Name(s)
fluticasone 0.005 %
Other Intervention Name(s)
Flixovate® 0.005%
Intervention Description
ointment
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Percentage of patients no longer presenting with 'facial' erythema at day 7 and day 21
Time Frame
1 week and 3 weeks
Title
Assessment of facial pruritus at day 1, day 7 and day 21
Time Frame
1 week and 3 weeks
Title
Global assessment of clinical response on the 'face' by the physician at day 7 and day 21
Time Frame
1 week and 3 weeks
Title
Global assessment of clinical response on the 'face' by the patient at day 7 and day 21
Time Frame
1 week and 3 weeks
Title
Patient's quality of life at day 1 and day 21
Time Frame
1 week and 3 weeks
Title
mLEASI score values at day 7 and day 21
Time Frame
1 week and 3 weeks
Title
Physician's assessment of individual signs
Time Frame
1 week and 3 weeks
Title
Quality of sleep at day 1, day 7 and day 21
Time Frame
1 week and 3 weeks
Title
Affected surface area assessment at day 1, day 7 and day 21
Time Frame
1 week and 3 weeks
Title
Number of patients using the ointment from the other group to treat facial lesions after day 21
Time Frame
3 weeks
Title
Incidences of adverse events during the study period
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Director
Facility Information:
City
Nice
ZIP/Postal Code
06202
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140566 in the JapicCTI-RNo. field

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Protopic Ointment in Adult Atopic Eczema of the Face

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