This single-center investigation will assess the prevalence of psoriasis in a population of patients with hepatitis C and compare the prevalence in those patients receiving pegylated interferon-* therapy to those not receiving pegylated interferon…
ID
Source
Brief title
Condition
- Cornification and dystrophic skin disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Efficacy outcome measurement will include evaluation of the skin for either the
presence or absence of psoriasis, through the psoriasis area severity index
(PASI) . Additionally, patients will be evaluated for total Body Surface Area
(BSA) involved. An average palm represents 1% of the BSA.
Secondary outcome
Not applicable
Background summary
Psoriasis is a chronic, immune-mediated disease characterized by erythematous,
scaly plaques on the skin. It is estimated that psoriasis affects 2% of the
general population. Psoriasis is thought to be an autoimmune disorder in which
the body attacks a currently unknown antigen in the skin. Most patients have a
genetic predisposition to develop psoriasis, and triggering factors include
infections, medications, or physical trauma to the skin.
Interferon is a naturally existing glycoprotein in the body. It possesses
immune modulating properties and is commonly used as a treatment for many
tumors and infections, including hepatitis C. Patients on interferon therapy
are at risk for developing autoimmune conditions and exacerbation of
pre-existing conditions. Psoriasis is among these conditions, and has been
reported both to be exacerbated and newly develop in patients on interferon
therapy. Psoriasis often improves when the interferon treatment is stopped.
Study objective
This single-center investigation will assess the prevalence of psoriasis in a
population of patients with hepatitis C and compare the prevalence in those
patients receiving pegylated interferon-* therapy to those not receiving
pegylated interferon-* treatments.
Study design
A goal of 80 consecutive hepatitis C patients,with and without pegylated
interferon-* treatment, will be evaluated by the department of dermatology at
the AMC directly after the visit with the hepatologist. These patients will
sign informed consent.. They will be given full body skin examinations to
evaluate for the presence of psoriasis.
The pegylated interferon-* must had been given for at least one dose, within
the last 6 months, as we would expect to see psoriasis persist in that period
of time. The dose, type and duration of pegylated interferon-* treatment will
be documented, as well as data about a history of diagnosed psoriasis and
treatment.
A detailed medical history will be taken and a full-body skin examination will
be performed, with special emphasis on typical sites of involvement with
psoriasis, such as elbows and knees, looking for erythema with squamae. The
examination of the skin will be standardized. The observer was blinded as to
whether or not the patients were treated with pegylated interferon-*.
If the skin examination reveals the presence of any kind of psoriasis,
photographs will be taken of the affected area, as a record . In case of doubt,
review by an second dermatologist will be performed. If the second
dermatologist thinks it is questionable too, patients will be scored as not
having psoriasis in the analysis.
The study procedures will include a review of the charts of the patients in the
clinic to evaluate the number of patients with the diagnosis of psoriasis, as
well as which of these patients are on pegylated interferon-* therapy.
Study burden and risks
There are no risks associated with patient participation in this study since no
study drugs will be given and no histology will be applied.
The data will give a contribution to the knowledge of developing or
exacerbation of psoriasis in treatment with pegylated interferon-*.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
1.Age 18 years or greater
2.Subjects must have a previous diagnosis of Hepatitis C. This would include all patients with a positive serology for Hepatitis C.
3.Patients in the treatment group should be treated for at least one dose, within the last 6 months, with pegylated interferon-*.
Exclusion criteria
1.Subjects younger than 18 years old
2.Subjects with any skin disease, disease state, or physical condition that would impair evaluation of the skin, for example not able to undress or stand up.
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 |
---|---|
CCMO | NL31109.018.10 |