NCT03762551

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
Last Updated

December 3, 2018

Status Verified

November 1, 2015

Enrollment Period

11 months

First QC Date

November 30, 2018

Last Update Submit

November 30, 2018

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

  • Measurement of the tissue level of JAK1 in both vitiligo and psoriasis patients before and after treatment with NB-UVB

    1 year

Study Arms (3)

vitiligo

EXPERIMENTAL

assess the level of JAK1 in vitiligo patients before and after treatment with NB-UVB

Other: skin biopsy

psoriasis

ACTIVE COMPARATOR

assess the level of JAK1 in psoriasis patients before and after treatment with NB-UVB

Other: skin biopsy

controls

OTHER

assess the level of JAK1 in controls

Other: skin biopsy

Interventions

skin biopsyOTHER

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.

controlspsoriasisvitiligo

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 30, 2018

First Posted

December 3, 2018

Study Start

December 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 3, 2018

Record last verified: 2015-11