- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03762551
Janus Kinase 1 in Vitiligo & Psoriasis
November 30, 2018 updated by: Maha Fathy Elmasry, Cairo University
Expression of Janus Kinase 1 in Vitiligo and Psoriasis Before and After Narrow Band UVB: a Case-Control Study
Assessment of the level of JAK1 in both vitiligo and psoriasis patients before and after treatment with NB-UVB which is considered a gold standard therapy for both diseases.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age above 12 years of age.
- psoriasis vulgaris or non-segmental vitiligo
- patients who received no systemic or topical treatment at least 6 weeks prior to enrollment into the study.
Exclusion Criteria:
- psoriasis patients with erythrodermic psoriasis, pustular psoriasis or associated psoriatic arthritis
- vitiligo patients with segmental or universal vitiligo were excluded from the study.
- any patient with a photosensitive disorder or any contraindication to phototherapy exposure, e.g., history or presence of malignant or premalignant skin lesions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: vitiligo
assess the level of JAK1 in vitiligo patients before and after treatment with NB-UVB
|
Two (4 mm) punch skin biopsies were taken from the 20 patients; one prior to the initiation of phototherapy and the other after the last session (from the same site).
One skin biopsy was taken from the skin of each of the 10 control healthy participants.
Skin biopsy specimens were preserved in Radio-Immunoprecipitation Assay (RIBA) buffer.
|
ACTIVE_COMPARATOR: psoriasis
assess the level of JAK1 in psoriasis patients before and after treatment with NB-UVB
|
Two (4 mm) punch skin biopsies were taken from the 20 patients; one prior to the initiation of phototherapy and the other after the last session (from the same site).
One skin biopsy was taken from the skin of each of the 10 control healthy participants.
Skin biopsy specimens were preserved in Radio-Immunoprecipitation Assay (RIBA) buffer.
|
OTHER: controls
assess the level of JAK1 in controls
|
Two (4 mm) punch skin biopsies were taken from the 20 patients; one prior to the initiation of phototherapy and the other after the last session (from the same site).
One skin biopsy was taken from the skin of each of the 10 control healthy participants.
Skin biopsy specimens were preserved in Radio-Immunoprecipitation Assay (RIBA) buffer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measurement of the tissue level of JAK1 in both vitiligo and psoriasis patients before and after treatment with NB-UVB
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2015
Primary Completion (ACTUAL)
November 1, 2016
Study Completion (ACTUAL)
November 1, 2016
Study Registration Dates
First Submitted
November 30, 2018
First Submitted That Met QC Criteria
November 30, 2018
First Posted (ACTUAL)
December 3, 2018
Study Record Updates
Last Update Posted (ACTUAL)
December 3, 2018
Last Update Submitted That Met QC Criteria
November 30, 2018
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dermatology 11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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