Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT01903317 |
| Other study ID # |
20139554 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 2013 |
| Est. completion date |
July 2015 |
Study information
| Verified date |
May 2024 |
| Source |
University of California, Irvine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this research study is to find out more about the relationship between vitamin
D and psoriasis.
Description:
Study Design Subjects will be recruited from an outpatient population of subjects with
psoriasis from Dr. Jennifer Soung's clinic at the Gottschalk Medical Plaza at the University
of California, Irvine. Subjects with the requisite diagnosis of psoriasis who are starting a
new form of therapy will be candidates for enrollment. Subjects who choose not to participate
in the study will receive their standard of care treatment without any monitoring for vitamin
D level. The protocol for this study is as follows.
Subjects will be screened and consented. Upon entry into the study, the study subject's
severity of disease will be evaluated by the investigator, using the Psoriasis Area and
Severity Index (PASI), Body Surface Area (BSA), and Physician's Global Assessment (PGA).
These assessments will be repeated at all future study visits.
Subjects will receive whichever standard of care treatment for their psoriasis as if they
were not participating in this study. Subjects will have their disease severity evaluated and
a vitamin D level drawn at Baseline (prior to initiating treatment), Week 12, Week 24, and
Week 52.
Study Procedures:
All study procedures will take place at the UCI Dermatology Research Center and Institute for
Clinical and Translational Research (ICTS) located at 843 Health Sciences Road, Irvine, CA
92697. The subject will be informed of his or her vitamin D level results at any time. Should
the level be dangerously low (per the laboratory reference point), the subject will be
treated for vitamin D deficiency as necessary per standard of care. Subjects will be
categorized as starting topical therapy, phototherapy and systemic therapy, or biologic
therapy. For all Vitamin D level testing in this protocol, the Vitamin D 25-hydroxy level
will be drawn, which involves 0.5mL of blood per draw.
Screening and Baseline: This visit will take approximately 30 minutes.
Written informed consent must be obtained prior to performance of any protocol-specific
procedures. The following procedures will be performed at Screening:
- Informed consent at the first Screening visit only.
- Subjects will be allocated a sequential identification number. After such assignment,
all subjects including drop-outs will be accounted for and fully documented through
withdrawal or study completion.
- Assessment of psoriasis diagnosis and confirmation of inclusion and exclusion criteria.
- Review of concomitant medication and therapy
- PASI, BSA, PGA assessment
- Laboratory testing: Vitamin D level
- Pregnancy assessment
Week 12: This visit will take approximately 15 minutes.
- PASI, BSA, PGA assessment
- Laboratory testing: Vitamin D level
- Review of concomitant medication and therapy
- Pregnancy assessment
Week 24: This visit will take approximately 15 minutes.
- PASI, BSA, PGA assessment
- Laboratory testing: Vitamin D level
- Review of concomitant medication and therapy
- Pregnancy assessment
Week 52: This visit will take approximately 15 minutes.
- PASI, BSA, PGA assessment
- Laboratory testing: Vitamin D level
- Review of concomitant medication and therapy
- Pregnancy assessment
Further descriptions of study procedures
Clinical Assessments:
Psoriasis Area and Severity Index (PASI) The Psoriasis Area and Severity Index (PASI)
quantifies the severity of a subject's psoriasis based on both lesion severity and the
percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator
of degree of erythema, induration, and scaling (each scored separately) for each of four body
regions, with adjustment for the percent of BSA involved for each body region and for the
proportion of the body region to the whole body.
Body Surface Area (BSA) Assessment of body surface area with psoriasis will be performed
separately for four body regions: head and neck, upper limbs, trunk (including axillae and
groin), and lower limbs (including buttocks). The percent surface area with psoriasis is
estimated by means of the handprint method, the full palmar hand of the subject.
Physician's Global Assessment (PGA) The Physician's Global Assessment of psoriasis is scored
on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling
across all psoriatic lesions. Average erythema, induration and scaling are scored separately
over the whole body according to a 5-point severity scale (0 to 4) as defined by morphologic
descriptors.
Clinical Laboratory Tests Blood samples will be collected at the timepoints indicated above.
All tests will be performed by UCI Pathology Services.
Pregnancy Assessment Female subjects of child-bearing potential will be asked if she is
pregnant or not. As the risks to a pregnant woman for participating in this study are minimal
(blood draw and breach of confidentiality), no pregnancy test will be done. However, should a
female subject declare herself to be pregnant, she will be withdrawn from the study.
