NCT03832751

Brief Summary

There is a need to know the role of human beta defensin-1 in vitiligo pathogenesis and the probability of finding newer and effective therapy for vitiligo in the future.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

February 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

9 months

First QC Date

February 5, 2019

Last Update Submit

February 5, 2019

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

  • Tissue levels of human beta-defensin 1 before and after NB-UVB phototherapy

    6 months to 1 year

Study Arms (2)

vitiligo patients

EXPERIMENTAL

Tissue levels of human beta-defensin 1 in vitiligo patients before and after NB-UVB phototherapy

Other: skin biopsy before and after NB-UVB phototherapy

Healthy controls

ACTIVE COMPARATOR

Tissue levels of human beta-defensin 1 in healthy controls

Other: skin biopsy before and after NB-UVB phototherapy

Interventions

skin biopsy before and after NB-UVB phototherapyOTHER

skin biopsy before and after NB-UVB phototherapy to measure tissue human beta-defensin 1

Healthy controlsvitiligo patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with non-segmental vitiligo.
  • Both genders.
  • Age more than 18 years old.
  • New cases or cases not receiving any treatment for at least 3 months prior to the study.

You may not qualify if:

  • Universal or segmental vitiligo.
  • Any contraindication to phototherapy treatment.
  • History of autoimmune diseases or other systemic diseases.
  • Any other skin disease.

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
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 5, 2019

First Posted

February 6, 2019

Study Start

March 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 6, 2019

Record last verified: 2019-02