NCT01459055

Brief Summary

Acrofacial vitiligo is a clinical form of vitiligo characterized by macules in distal digits, periorificial-facial and ano-genital areas. Vitiligo European Task Force classifies vitiligo as generalized or localized; generalized vitiligo may be further sub-divided into acrofacial, vulgaris and universalis, and localized vitiligo, into segmental and focal. Some authors do not believe that acrofacial is a real vitiligo clinical form, considering it as an initial form of vulgaris vitiligo. The aim of this study is to follow early- diagnosed acrofacial patients during ten years in order to define if these patients will maintain this clinical form or will evolute to a more severe clinical form.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

October 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
4.5 years until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

May 3, 2016

Status Verified

May 1, 2016

Enrollment Period

8 months

First QC Date

October 21, 2011

Last Update Submit

May 2, 2016

Conditions

Vitiligo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of both genders affected by acrofacial vitiligo diagnosed by one single dermatologist.

You may qualify if:

  • Patients of both genders, aged older than years, able to understand and provide written informed consent and able to allow compliance at the treatment and the requirements of the protocol;
  • Presence of acrofacial vitiligo;
  • Able to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines.

You may not qualify if:

  • Subjects assessed as not suitable for the study in the opinion of the investigator
  • Inability to complete survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irmandade da Santa Casa de Misericórdia de Curitiba

Curitiba, Paraná, 80730000, Brazil

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Caio C Silva de Castro, MD, PhD

    Irmandade da Santa Casa de Misericórdia de Curitiba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caio Cesar C Castro, MD, PhD

CONTACT

00554135682036caio.castro@pucpr.br

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 21, 2011

First Posted

October 25, 2011

Study Start

May 1, 2016

Primary Completion

January 1, 2017

Study Completion

August 1, 2020

Last Updated

May 3, 2016

Record last verified: 2016-05

Locations

BR(1)