Photoprotection Habits in Patients With Vitiligo (VITISUN)

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 ≤ 0.05 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.

Study Overview

• Status: Completed
• Conditions: Vitiligo; PHOTOPROTECTION; SUN-EXPOSITION; FITZPATRICK SCALE
• Intervention / Treatment: Other: Self-Assessment Questionnaire

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94010
    • Assistance Publique Hôpitaux de Paris - CHU Henri Mondor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We aim to conduct a prospective cross sectional study in patients with Vitiligo (adults> 18 years of age). 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.

Description

Inclusion Criteria:

• Age >=18 y.o
• Men or women with Vitiligo

Exclusion Criteria:

• Oral or written opposition expressed by patient
• Patient under tutorship or curatorship
• cognitive dysfunction making communication or questionnaire filling impossible

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
estimation of skin sun reaction: Fitzpatrick scale	Fitzpatrick scale is a numerical classification scale for human skin color that help to estimate skin reaction towards ultraviolet light exposure. It contains six categories, Type I is the fairest skin complexion and type VI is the darkest complexion : Type I (scores 0-6) always burns, never tans (pale white; blond or red hair; blue eyes; freckles). Type II (scores 7-13) usually burns, tans minimally (white; fair; blond or red hair; blue, green, or hazel eyes) Type III (scores 14-20) sometimes mild burn, tans uniformly (cream white; fair with any hair or eye color) Type IV (scores 21-27) burns minimally, always tans well (moderate brown) Type V (scores 28-34) very rarely burns, tans very easily (dark brown) Type VI (scores 35-36) Never burns, never tans (deeply pigmented dark brown to darkest brown)	At inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vitiligo outbreak	vitiligo outbreak: new stain in the 3 last months	At inclusion
Auto evaluation of vitiligo severity: SA-VES	SA-VES (Self-Assessment - Vitiligo Extent Score)(1) is a patient reported outcome that measure the severity of vitiligo and its body extent from the patient perspective. Patients scored less than 10 are considered as less severe. (1)Development and validation of a patient-reported outcome measure in vitiligo: The Self Assessment Vitiligo Extent Score (SA-VES). van Geel N, Lommerts JE, Bekkenk MW, Prinsen CA, Eleftheriadou V, Taieb A, Picardo M, Ezzedine K, Wolkerstorfer A, Speeckaert R; international Vitiligo Score Working Group.. J Am Acad Dermatol. 2017 Mar;76(3):464-471.	At inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 16, 2017
• Primary Completion (ACTUAL): April 16, 2018
• Study Completion (ACTUAL): April 16, 2018

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (ACTUAL): October 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: NI17014J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No