- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05336422
Sun Exposure of Outdoor Workers in Mayotte and Reunion Island (EXTRASOL)
The UV index in Mayotte and Reunion is greater than 14, eight months out of twelve. This index decreases linearly over the period from mid-April to mid-August where it can drop to reach an index of 8 in July. The inhabitants are therefore exposed to a maximum intensity of UV radiation according to the World Health Organization (WHO).
The WHO recommends extreme precautions for indices greater than 11 (avoid exposure between 11 a.m. and 3 p.m. (GMT+3 hours), stay in the shade, wear a t-shirt, sunglasses, hat and sunscreen).
Sun exposure is a major risk factor in the development of skin cancer, basal cell cancer, squamous cell cancer and cutaneous melanoma. It is also the cause of premature aging of the skin. Furthermore, it causes ocular complications such as the occurrence of cataracts and this without distinction of skin phenotype.
There is currently no prevention campaign on the risks of sun exposure in Mayotte or Reunion for adults, while many risky behaviors are observed both in the professional field and during leisure activities. In order to better understand risk-taking and choose appropriate awareness-raising tools, it is necessary to identify the knowledge, attitudes and practices (KAP) of these populations in terms of risk of sun exposure and to measure the impact of solar prevention education actions.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Live in Mayotte or Reunion island
- > 18 years old
- Work outdoors > 2 hours a day in one of the identified professions
- Belong to the list of targeted companies
Exclusion Criteria:
- Person deprived of liberty by judicial or administrative decision, minor, and person subject to a legal protection measure: guardianship or curators
- Person not agreeing to participate
- No one speaking any of the following languages: English / French / Shimaore / Kibushi / Creole or Comorian
- Person who cannot be followed during the 6 months of the study
- Inability to answer the questionnaire
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: training on the risks associated with sun exposure
power point on the risks associated with sun exposure
|
15-minute power point and presentation on the risks of sun exposure
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the knowledge of photo-exposed workers on the risks associated with exposure to the sun.
Time Frame: 6 month
|
knowledge quiz
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the change in attitudes and practices of photo-exposed workers
Time Frame: 6 month
|
attitudes and practices of photo-exposed workers quiz
|
6 month
|
fitzpatrick scale : classification of skin types (phototype I to VI)
Time Frame: 6 month
|
phototype and knowledge level
|
6 month
|
knowledge questionnaire
Time Frame: 6 month
|
phototype and knowledge level
|
6 month
|
Obtain UV dosimetry data by occupation to confirm risk exposure during working hours.
Time Frame: 6 month
|
dosimetry data
|
6 month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021/CHU/38
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sun Exposure
-
Centre Hospitalier Universitaire de la RéunionNot yet recruitingSun ExposureMayotte, Réunion
-
Massachusetts General HospitalProcter and GambleTerminatedHealthy | Sun ExposureUnited States
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Bispebjerg HospitalCompletedQuantity of Sunscreen | Sun Protection Factor | Sun Safety Campaigns | Sunscreen UseDenmark
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BayerCompleted
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University of California, DavisCompletedSun Damaged SkinUnited States
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Northwestern UniversityCompletedChildren | Parents | Sun ProtectionUnited States
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University of MichiganUnilever R&DCompletedSun-Damaged Skin | Retinoid IntoleranceUnited States
-
Northwestern UniversityCompletedSkin Cancer | Sun Sensitivity | Sun ProtectionUnited States
Clinical Trials on training on the risks associated with sun exposure
-
Centre Hospitalier Universitaire de la RéunionNot yet recruitingSun ExposureMayotte, Réunion
-
Centre Hospitalier Universitaire de Saint EtiennePierre Fabre Dermo CosmetiqueTerminatedSkin Cancer | Skin AgingFrance
-
Aylin KurtRecruitingChildren, Only | Fear Anxiety | Hospitalism in ChildrenTurkey
-
Psychiatric Research Unit, Region Zealand, DenmarkUniversity of CopenhagenCompleted
-
Medical University of BialystokRecruitingCOVID-19 | RehabilitationPoland
-
Oslo University HospitalHelse Sor-Ost; The Royal Norwegian Ministry of Health; Stiftelsen Helse og RehabiliteringCompleted
-
University of Castilla-La ManchaCompleted
-
University of ExtremaduraCompleted
-
Fudan UniversityUnknown
-
Biruni UniversityCompletedOveractive Bladder