Sun ExposureEXTRASOLNCT05336422
Sun Exposure of Outdoor Workers in Mayotte and Reunion Island
A study testing training on the risks associated with sun exposure in people with Sun Exposure, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sun Exposure
- What is being tested?
- training on the risks associated with sun exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2022to Jan 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Mayotte1 site
Mayotte
Chirongui
Jessica DUMEZ, MD, MSc
About this study
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).
Read more
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.
- Conditions
- Sun Exposure
- Being tested
- training on the risks associated with sun exposure
- Keywords
- workers, sun exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training on the risks associated with sun exposureOther
Also called dosimetry
15-minute power point and presentation on the risks of sun exposure
| Study group | Role | What they receive |
|---|---|---|
| training on the risks associated with sun exposure | Experimental | power point on the risks associated with sun exposure Receives: Other: training on the risks associated with sun exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the knowledge of photo-exposed workers on the risks associated with exposure to the sun.
knowledge quiz
Measured: 6 month
Secondary outcomes (4)
Assess the change in attitudes and practices of photo-exposed workers
attitudes and practices of photo-exposed workers quiz
Measured: 6 month
fitzpatrick scale : classification of skin types (phototype I to VI)
phototype and knowledge level
Measured: 6 month
knowledge questionnaire
phototype and knowledge level
Measured: 6 month
Obtain UV dosimetry data by occupation to confirm risk exposure during working hours.
dosimetry data
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sun ExposureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336422
- Sponsor's protocol ID
- 2021/CHU/38
- Acronym
- EXTRASOL
- Status last verified
- Apr 2022
- First submitted
- 14 Mar 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sun Exposure of Outdoor Workers in Mayotte and Reunion Island
- ClinicalTrials.gov ID
- NCT05336422
- Acronym / sponsor ID
- EXTRASOL / 2021/CHU/38
- Conditions
- Sun Exposure
- Keywords
- workers, sun exposure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 20 Apr 2022 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| training on the risks associated with sun exposure | Experimental | Other: training on the risks associated with sun exposurepower point on the risks associated with sun exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| training on the risks associated with sun exposureAlso: dosimetry15-minute power point and presentation on the risks of sun exposure | Other | training on the risks associated with sun exposure |
Primary outcome
Assess the knowledge of photo-exposed workers on the risks associated with exposure to the sun.
Time frame: 6 month
knowledge quiz
4 secondary outcomes
Assess the change in attitudes and practices of photo-exposed workers
Time frame: 6 month
fitzpatrick scale : classification of skin types (phototype I to VI)
Time frame: 6 month
knowledge questionnaire
Time frame: 6 month
Obtain UV dosimetry data by occupation to confirm risk exposure during working hours.
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Sun Exposure
Active, not recruiting
Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions
Melanoma (Skin Cancer)
RecruitingPhase 3
Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
Cutaneous Squamous Cell Carcinoma (CSCC)
RecruitingPhase 4
A Clinical Study to Evaluate the Efficacy and SPF of Two Test Materials According to an Adaptation of the Guidelines of the FDA Sunscreen Drug Products for Over-the-Counter Human Use
Epidermis, Ultraviolet Exposure
Active, not recruiting
Improvement of Sleep Disorders in Patients With Alzheimer's Disease After Sunlight Exposure Therapy.
Alzheimer's Disease (AD), Sleep Disorders, Circadian Rhythm
Recruiting
SUV PDL1/PD1 in Sun Damaged & Sun Protected Human Skin of Participants
Other Skin Changes Due to Chronic Exposure to Nonionizing Radiation
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training on the risks associated with sun exposure in people with Sun Exposure, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in 2 countries.
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 4 inclusion and 5 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 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mayotte, Reunion. 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 Lucie AUZANNEAU (0262359949 ext. +262, lucie.auzanneau@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the knowledge of photo-exposed workers on the risks associated with exposure to the sun. (time frame: 6 month). 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 20 Apr 2022.