NCT00691262

Brief Summary

Objective of this study is to further assess the response to treatment and safety of 0.03% tacrolimus (FK506) ointment when used for 6 months in pediatric patients with moderate to severe atopic dermatitis, known to be responsive to topical steroids.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2008

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

Enrollment Period

1.3 years

First QC Date

June 3, 2008

Last Update Submit

August 29, 2014

Conditions

Dermatitis, Atopic

Keywords

Atopic dermatitisPrografTacrolimusFK506Tacrolimus ointment

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (2)

  • 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 before month 6) visit

    1 year

  • The rate of patients with at least 60% improvement in the Score in Atopic Dermatitis (SCORAD) at month 6/end of study (if before month 6) visit and at month 12/end of study (if after month 6) visit, each compared to baseline (day 1)

    1 year

Study Arms (1)

1

EXPERIMENTAL
Drug: tacrolimus ointment

Interventions

tacrolimus ointmentDRUG

transdermal

Also known as: FK506
1

Eligibility Criteria

Age2 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patient may be male or female of any ethnic group
  • Patient is aged 2 years to 15 years (not having completed his/her 16th birthday) 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's legal representative has given written informed consent. If the patient is capable of understanding the purposes and risks of the trial written informed consent has been obtained from the patient as well. 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 wash-out 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/patient and legal representative agree that the patient does not take for the complete study period any medication or therapy prohibited by the protocol

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Bologna, 40100, Italy

Location

Unknown Facility

Catania, 95124, Italy

Location

Unknown Facility

Genova, 16100, Italy

Location

Unknown Facility

Lecco, 23900, Italy

Location

Unknown Facility

Napoli, 80138, Italy

Location

Unknown Facility

Padua, 35128, Italy

Location

Unknown Facility

Roma, 00161, Italy

Location

Unknown Facility

Roma, 00165, Italy

Location

Unknown Facility

Roma, 00167, Italy

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Central Contact

    Astellas Pharma Europe B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 5, 2008

Study Start

October 1, 2003

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

September 1, 2014

Record last verified: 2014-08

Locations

IT(9)