The objective of the study is to assess the long-term safety of tacrolimus ointment 0.03% or 0.1% in the treatment of subjects with atopic dermatitis under actual use conditions, including the risk of developing cutaneous or systemic malignancies.…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters are the frequency of all Serious Adverse Events
(SAEs), including but not limited to the following:
- the total systemic malignancies diagnosed more than 6 months after the
initiation of tacrolimus ointment treatment
- Hodgkin's / Non-Hodgkin's lymphoma diagnosed more than 6 months after the
initiation of tacrolimus ointment treatment, and
- Cutaneous malignancies (melanoma and non-melanoma skin cancer) diagnosed more
than 6 months after the initiation of tacrolimus ointment treatment
Secondary outcome
Not applicable.
Background summary
December 2000, the Food and Drug Administration (FDA) approved Protopic®
(tacrolimus ointment), 0.03% Protopic® in children and 0.1% Protopic® in
adults, for the treatment of atopic dermatitis (AD). October 2001 the EMEA
(European Agency for the Evaluation of Medicinal Products) also approved both
formulations for the same indication.
As part of the approval process, both the FDA and the EMEA requested a
post-marketing commitment regarding the safety of long-term use of tacrolimus
ointment in pediatric AD subjects.
After long negotations with the FDA in March 2005 the final protocol was
released. Initially only the USA, Germany, United Kingdom and Ireland were
involved. Recently it has been decided to expand the number of participating
countries. Among those countries are the Netherlands, Poland and Canada.
Study objective
The objective of the study is to assess the long-term safety of tacrolimus
ointment 0.03% or 0.1% in the treatment of subjects with atopic dermatitis
under actual use conditions, including the risk of developing cutaneous or
systemic malignancies. In this study a large cohort of subjects who have used
tacrolimus for the first time before the age of 16 years will be followed on
the long-term.
Study design
In this study approximately 8,000 subjects will be enrolled, who have used
tacrolimus for the first time before the age of 16 years. Each subject will be
followed for 10 years after enrollment.
During these follow-up period there will be a yearly physical examination and
every two years in combination with a dermatological examination.
In addition each subject will be interviewed twice a year either by telephone
or by mail (or internet) to answer a short list of questions. The choice is up
to the subject. These questions concern the subject status, medication,
physician office visits scheduled and biopsies and hospitalizations.
Study burden and risks
In principle there is no burden and risks involved in this study. There will be
no study medication provided to the subjects. For study purposes there will be
no bloodsampling or other invasive procedures.
The only burden for subjects are the yearly visits to the physician and twice a
year answering a short questionnaire.
Elisabethhof 19
2353 EW
NL
Elisabethhof 19
2353 EW
NL
Listed location countries
Age
Inclusion criteria
1) Subject has/ had atopic dermatitis
2) Subject has applied tacrolimus ointment 0.03% or 0.1% for at least 6 weeks either continuously or intermittently. This may include subjects who have been enrolled in previous tacrolimus ointments studies and or subjects with commercial product exposure prior to study enrollment.
3) Subject age at first tacrolimus ointment exposure is /was < 16 years.
4) Subject / caregiver has given written informed and assent.
5) Subject / caregiver agrees to comply with the program requirements including an annual physical examination and biennal dermatological exam and agrees to be contacted and provide information.
Exclusion criteria
Not applicable
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT00475605 |
| CCMO | NL18631.018.07 |