VitiligoNCT01459055
Long-term Follow-up in Patients Affected With Acrofacial Vitiligo
An observational study of Vitiligo, run by Irmandade da Santa Casa de Misericordia de Curitiba at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- May 2016to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of both genders affected by acrofacial vitiligo diagnosed by one single dermatologist.
Who may be able to join
- 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.
Who cannot join
- 1- Subjects assessed as not suitable for the study in the opinion of the investigator
- 2 -Inability to complete survey
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Irmandade da Santa Casa de Misericórdia de Curitiba
Curitiba, Paraná, 80730000
Caio Cesar Silva de Castro, MD, PhD, 00554135682036, caio.castro@pucpr.br
Caio C Silva de Castro, MD, PhD
About this study
Official title: Long-term Ten Years Follow-up in Patients Affected With Acrofacial Vitiligo
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.
- Conditions
- Vitiligo
- Medical subject headings
- Vitiligo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startMay 2016
- Primary completionJan 2017 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Irmandade da Santa Casa de Misericordia de Curitiba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caio Cesar Silva de Castro, Irmandade da Santa Casa de Misericordia de Curitiba
- Investigators
- Caio C Silva de Castro, MD, PhD, Principal investigator, Irmandade da Santa Casa de Misericórdia de Curitiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459055
- Sponsor's protocol ID
- ACRO01
- Status last verified
- May 2016
- First submitted
- 21 Oct 2011
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Ten Years Follow-up in Patients Affected With Acrofacial Vitiligo
- ClinicalTrials.gov ID
- NCT01459055
- Acronym / sponsor ID
- ACRO01
- Conditions
- Vitiligo
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Irmandade da Santa Casa de Misericordia de CuritibaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of both genders affected by acrofacial vitiligo diagnosed by one single dermatologist.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 1- Subjects assessed as not suitable for the study in the opinion of the investigator
- 2 -Inability to complete survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caio C Silva de Castro, MD, PhD principal investigator
Irmandade da Santa Casa de Misericórdia de Curitiba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitiligo, run by Irmandade da Santa Casa de Misericordia de Curitiba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caio Cesar C Castro, MD, PhD (00554135682036, caio.castro@pucpr.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2016.