Back to resultsJanus Kinase 1 in Vitiligo & Psoriasis
Primary Purpose
Vitiligo
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
skin biopsy
Sponsored by
About this trial
This is an interventional other trial for Vitiligo
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
vitiligo
psoriasis
controls
Arm Description
assess the level of JAK1 in vitiligo patients before and after treatment with NB-UVB
assess the level of JAK1 in psoriasis patients before and after treatment with NB-UVB
assess the level of JAK1 in controls
Outcomes
Primary Outcome Measures
Measurement of the tissue level of JAK1 in both vitiligo and psoriasis patients before and after treatment with NB-UVB
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03762551
Brief Title
Janus Kinase 1 in Vitiligo & Psoriasis
Official Title
Expression of Janus Kinase 1 in Vitiligo and Psoriasis Before and After Narrow Band UVB: a Case-Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitiligo
Arm Type
Experimental
Arm Description
assess the level of JAK1 in vitiligo patients before and after treatment with NB-UVB
Arm Title
psoriasis
Arm Type
Active Comparator
Arm Description
assess the level of JAK1 in psoriasis patients before and after treatment with NB-UVB
Arm Title
controls
Arm Type
Other
Arm Description
assess the level of JAK1 in controls
Intervention Type
Other
Intervention Name(s)
skin biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of the tissue level of JAK1 in both vitiligo and psoriasis patients before and after treatment with NB-UVB
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Janus Kinase 1 in Vitiligo & Psoriasis
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