Protopic Ointment in Adult Atopic Eczema of the Face

Dermatitis, Atopic Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690105
• Other study ID #: FG-506-06-FR-04
• Secondary ID: EUDRACT #: 2004-
• Status: Completed
• Phase: Phase 4
• First received: June 2, 2008
• Last updated: August 28, 2014
• Start date: February 2004
• Est. completion date: July 2005

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: Federal Agency for Medicinal Products and Health ProductsFinland: Finnish Medicines AgencyTunisia: Office of Pharmacies and MedicinesMorocco: Ministry of Public HealthRomania: National Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 577
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		3 weeks	No
Secondary	Percentage of patients no longer presenting with 'facial' erythema at day 7 and day 21		1 week and 3 weeks	No
Secondary	Assessment of facial pruritus at day 1, day 7 and day 21		1 week and 3 weeks	No
Secondary	Global assessment of clinical response on the 'face' by the physician at day 7 and day 21		1 week and 3 weeks	No
Secondary	Global assessment of clinical response on the 'face' by the patient at day 7 and day 21		1 week and 3 weeks	No
Secondary	Patient's quality of life at day 1 and day 21		1 week and 3 weeks	No
Secondary	mLEASI score values at day 7 and day 21		1 week and 3 weeks	No
Secondary	Physician's assessment of individual signs		1 week and 3 weeks	No
Secondary	Quality of sleep at day 1, day 7 and day 21		1 week and 3 weeks	No
Secondary	Affected surface area assessment at day 1, day 7 and day 21		1 week and 3 weeks	No
Secondary	Number of patients using the ointment from the other group to treat facial lesions after day 21		3 weeks	No
Secondary	Incidences of adverse events during the study period		6 weeks	No

External Links

•   Link to Results on JAPIC - enter 140566 in the JapicCTI-RNo. field