Clinical trial NCT00691145: Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis
Official title: A Long-term, Non-comparative, Multi-centre Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus (FK506) Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis FG-506-06-IT-01
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dermatitis, Atopic
Keywords: Atopic dermatitis
Tacrolimus ointment
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the efficacy and safety of 0.1% and 0.03% Tacrolimus ointment for 12 months in adults with moderate to severe atopic dermatitis.

Detailed description: The main phase is 6 months duration, but the follow up phase up to 12 months will allow the collection of efficacy and safety data in a period which will include all seasons in each patient, to account for seasonal variability which strongly affect atopic dermatitis course.

Eligibility criteria: Inclusion Criteria:

* Patient may be male or female of any ethnic group
* Patient without restricted legal competence, and suffers from moderate to severe atopic dermatitis (Rajka/Langeland score of at least 4.5)
* Patient known to be responsive to topical steroids
* Patient is capable of understanding the purposes and risks of the trial and has given written Informed Consent
* Female patients of childbearing potential must agree to maintain adequate birth control practice during the trial period and during the first four weeks after the end of the study
* Patient meets the following criteria:

  * Topical corticosteroids
  * Systemic corticosteroids (for the treatment of AD only)
  * Systemic non-steroidal immunosuppressants (e.g. cyclosporine, methotrexate)
  * Other investigational drugs
  * Light Treatments (UVA, UVB)
* Patient has not taken and agrees not to take for the complete study period any medication or therapy prohibited by the protocol

Exclusion Criteria:

* Patient has a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma
* Patient is pregnant or breast-feeding
* Patient has a skin infection on the affected (and to be treated) area
* Patient has a known hypersensitivity to macrolides in general, to tacrolimus or any excipient of the ointment
* Patient is simultaneously participating in any other drug trial or less than 28 days have passed between the end of the previous trial and this one
* Any form of substance abuse (including drug or alcohol abuse),psychiatric disorder or condition which, in the opinion of the investigator, may invalidate the communication with the investigator
* Patient is known to be HIV positive

Primary outcomes:
measure: The rate of patients with at least 50% (i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 6/end of study (if before month 6) visit
timeFrame: 1 year
Secondary outcomes:
measure: The rate of patients with at least 50%(i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 12/end of study (if after month 6) visit
timeFrame: 1 year
measure: The rate of patients with at least 60% improvement in the Score In Atopic Dermatitis (SCORAD) at month 6/end of study visit (if before month 6) and at month 12/end of study (if after month 6) visit, each compared to baseline (day 1)
timeFrame: 1 year
measure: The incidence of adverse events during the study, including all clinically significant laboratory values
timeFrame: 1 year
Other outcomes:
Locations:
city: S. Giovanni Rotondo
country: Italy
state: Foggia
city: Battipaglia
country: Italy
state: Salerno
city: Ancona
country: Italy
city: Bari
country: Italy
city: Benevento
country: Italy
city: Bergamo
country: Italy
city: Bolzano
country: Italy
city: Catania
country: Italy
city: Genova
country: Italy
city: Mantova
country: Italy
city: Merano
country: Italy
city: Messina
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Novara
country: Italy
city: Parma
country: Italy
city: Pavia
country: Italy
city: Perugia
country: Italy
city: Reggio Emilia
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Sassari
country: Italy
city: Siena
country: Italy
city: Torino
country: Italy
city: Trieste
country: Italy
city: Venezia
country: Italy
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Central Contact
role: STUDY_DIRECTOR
References: