VitiligoVITISUNNCT03323125
Photoprotection Habits in Patients With Vitiligo
An observational study of Vitiligo and PHOTOPROTECTION, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo, PHOTOPROTECTION, SUN-EXPOSITION
- What is being tested?
- Self-Assessment Questionnaire
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2017to 16 Apr 2018
- 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: 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.
Who may be able to join
- Age >=18 y.o
- Men or women with Vitiligo
Who cannot join
- Oral or written opposition expressed by patient
- Patient under tutorship or curatorship
- cognitive dysfunction making communication or questionnaire filling impossible
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, 94010
About this study
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.
Read more
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.
- Conditions
- Vitiligo, PHOTOPROTECTION, SUN-EXPOSITION, FITZPATRICK SCALE
- Being tested
- Self-Assessment Questionnaire
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Assessment QuestionnaireOther
Self-assessment questionnaire with sun exposition, sun protection, vitiligo severity and vitiligo outbreaks, will be suggested to patient during medical consultation.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At inclusion
Secondary outcomes (2)
vitiligo outbreak
vitiligo outbreak: new stain in the 3 last months
Measured: 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.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start16 Oct 2017
- Primary completion16 Apr 2018
- Study completion16 Apr 2018
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323125
- Sponsor's protocol ID
- NI17014J
- Acronym
- VITISUN
- Status last verified
- Oct 2017
- First submitted
- 24 Oct 2017
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photoprotection Habits in Patients With Vitiligo
- ClinicalTrials.gov ID
- NCT03323125
- Acronym / sponsor ID
- VITISUN / NI17014J
- Conditions
- Vitiligo, PHOTOPROTECTION, SUN-EXPOSITION, FITZPATRICK SCALE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 16 Apr 2018 (actual)
- First posted
- 26 Oct 2017 (actual)
- 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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age >=18 y.o
- Men or women with Vitiligo
Key exclusion criteria (3 listed)
- Oral or written opposition expressed by patient
- Patient under tutorship or curatorship
- cognitive dysfunction making communication or questionnaire filling impossible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Assessment QuestionnaireSelf-assessment questionnaire with sun exposition, sun protection, vitiligo severity and vitiligo outbreaks, will be suggested to patient during medical consultation. | Other | – |
Primary outcome
estimation of skin sun reaction: Fitzpatrick scale
Time frame: At inclusion
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)
2 secondary outcomes
vitiligo outbreak
Time frame: At inclusion
Auto evaluation of vitiligo severity: SA-VES
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and PHOTOPROTECTION, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 26 Jun 2018. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
estimation of skin sun reaction: Fitzpatrick scale (time frame: At inclusion). It is what the study was designed to measure, not a finding.
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 26 Jun 2018.