Ignite Creation Date:
2024-05-06 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03323125
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2017-10-24
Brief Title:
Photoprotection Habits in Patients With Vitiligo
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Photoprotection Habits in Patients With Vitiligo
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VITISUN
Brief Summary:
Intro
Patients with vitiligo have a reduced protection on depigmented areas To date however little is known about photoprotection habits in patients with vitiligo even though these patients are thought to have a decreased ability to efficiently protect their skin against sun damage Moreover exposure to artificial UV is one of the major elements of the treatment of vitiligo even though certain phenotypes of vitiligo could be photoinduced
Hypothesis The Primary objective is to describe patients behaviour with sun exposition
The Secondary objectives are
to assess the link between sun exposition and vitiligo outbreaks
to assess photoprotection habits according to initial phototype and vitiligo severity SA-VES
To validate a short form of the VIPs questionnaire a validated burden questionnaire
Method We aim to conduct a prospective cross sectional study in patients with Vitiligo with the aim to evaluate sun protection habits in patients with vitiligo For that purpose a semi-directed questionnaire to investigate the sun protection behavior of vitiligo patients adults 18 years of age have been created by experts in the field Vitiligo severity will be self-assessed by patients using a recently validated patient reported outcome the SA-VES Consecutive vitiligo patients consulting in the dermatology department of Henri Mondor Hospital Créteil France will be proposed to participate the study after having given their oral consent We are planning to enrol 500 patients
In a first step a descriptive analysis will be carried out in order to describe the characteristics of the sample Basic summary statistics such as proportions means and standard deviations will be used to characterize the population In order to identify the factors associated with the severity of the disease on the one hand and the phototype on the other comparisons between groups severe versus non-severe and light phototype versus dark phototype will be carried out by unconditional logistic regression All potential predictors of severity will first be assessed individually and Odds Ratio OR corresponding 95 CIs and P values will be calculated The significance of the OR will be determined by the Wald test χ2 and the predictors with P 20 will then be evaluated using a multivariate analysis with a pre-selection procedure Possible interactions and multi-colinearity will be examined Finally the quality of fit of the final model will be evaluated using the logistic regression diagnostic procedure P 005 will be considered as statistically significant The Hosmer-Lemeshow test will be carried out to test the suitability of the model
Conclusion This study will help to identify gaps in the knowledge of sun protection habits in patients with vitiligo
Patients with vitiligo have a reduced protection on depigmented areas To date however little is known about photoprotection habits in patients with vitiligo even though these patients are thought to have a decreased ability to efficiently protect their skin against sun damage Moreover exposure to artificial UV is one of the major elements of the treatment of vitiligo even though certain phenotypes of vitiligo could be photoinduced
Hypothesis The Primary objective is to describe patients behaviour with sun exposition
The Secondary objectives are
to assess the link between sun exposition and vitiligo outbreaks
to assess photoprotection habits according to initial phototype and vitiligo severity SA-VES
To validate a short form of the VIPs questionnaire a validated burden questionnaire
Method We aim to conduct a prospective cross sectional study in patients with Vitiligo with the aim to evaluate sun protection habits in patients with vitiligo For that purpose a semi-directed questionnaire to investigate the sun protection behavior of vitiligo patients adults 18 years of age have been created by experts in the field Vitiligo severity will be self-assessed by patients using a recently validated patient reported outcome the SA-VES Consecutive vitiligo patients consulting in the dermatology department of Henri Mondor Hospital Créteil France will be proposed to participate the study after having given their oral consent We are planning to enrol 500 patients
In a first step a descriptive analysis will be carried out in order to describe the characteristics of the sample Basic summary statistics such as proportions means and standard deviations will be used to characterize the population In order to identify the factors associated with the severity of the disease on the one hand and the phototype on the other comparisons between groups severe versus non-severe and light phototype versus dark phototype will be carried out by unconditional logistic regression All potential predictors of severity will first be assessed individually and Odds Ratio OR corresponding 95 CIs and P values will be calculated The significance of the OR will be determined by the Wald test χ2 and the predictors with P 20 will then be evaluated using a multivariate analysis with a pre-selection procedure Possible interactions and multi-colinearity will be examined Finally the quality of fit of the final model will be evaluated using the logistic regression diagnostic procedure P 005 will be considered as statistically significant The Hosmer-Lemeshow test will be carried out to test the suitability of the model
Conclusion This study will help to identify gaps in the knowledge of sun protection habits in patients with vitiligo
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None