Psoriasis VulgarisNCT04740983
Ultraviolet Radiation Forecasting Based Heliotherapy For Psoriasis in Bangkok, Thailand
A study testing Heliotherapy (a sole sun-bathing) in people with Psoriasis Vulgaris, run by Chulalongkorn University.
Trial summary
Due to limited number of phototherapy centres and shortage of qualified phototherapy practitioners, heliotherapy has become a promising treatment alternative in Thailand where patients effortlessly receive supervised sun-bathing treatments from their homes whenever they are convenient. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Heliotherapy (a sole sun-bathing)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2021to 31 Dec 2021
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A psoriasis patient who indicate to have phototherapy and have lesional plagues systemically either on the front-back or left-right.
- A participant is based in Bangkok
- A participant is capable to understand and learn how to use our in-house assembled UV metre and web-based heliotherapy platform.
Who cannot join
- A participant has any sun-sensitive conditions including photo-aggravated photodermatoses and on photosentisitive drug treatments.
- Breast-feeding, pregnant individuals.
About this study
Official title: The Study of Efficacy and Safety of UV Forecasting Based Heliotherapy For Psoriasis in Bangkok, Thailand: A Split-side Pilot Study
Due to limited number of phototherapy centres and shortage of qualified phototherapy practitioners, heliotherapy has become a promising treatment alternative in Thailand where patients effortlessly receive supervised sun-bathing treatments from their homes whenever they are convenient. We used newly designed deep neural network UV forecasting model developed by using our 10 year-retrospective Solar UV irradiance (280-400 nm) retrieved from a ground based platform at Atmosperic laboratory, Silpakorn University, Nakhon Pathom, Thailand (13.82N 100.04E, 30 m above mean sea level). This model achieved a next-day forecast error of less than 12% which has been the most accurate prediction to date. We designed our 10week heliotherapy regimen based on the predicted anti psoriasis effective irradiance values. We studied efficacy and safety of the 12-week heliotherapy regimen for psoriasis on only ruled acceptable clear sky days in Bangkok, Thailand
Read the detailed description
We studied efficacy and safety of the 16-week heliotherapy regimen for psoriasis on only ruled acceptable clear sky days in Bangkok, Thailand
- Conditions
- Psoriasis Vulgaris
- Being tested
- Heliotherapy (a sole sun-bathing)
- Keywords
- Heliotherapy, sun-bathing, psoriasis, ultraviolet radiation, forecasting, Thailand
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heliotherapy (a sole sun-bathing)Other
16-week heliotherapy regimen based on the predicted anti psoriasis effective irradiance values.
| Study group | Role | What they receive |
|---|---|---|
| Heliotherapy | Experimental | will receive 16-week heliotherapy regimen based on the predicted anti psoriasis effective irradiance values along with olive oil (in-house formulation) Receives: Other: Heliotherapy (a sole sun-bathing) |
| Control | No intervention | only will receive olive oil (in-house formulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Targeted PASI score
PASI score for targeted plagues will be evaluated by two independent dermatologists (EB, PA) from standard digital photographs.
Measured: 16 weeks
Secondary outcomes (1)
Incidence of possible acute side effects after sun bathing
Potential acute effects of the exposure of full-spectrum solar radiation
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start15 Mar 2021 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- King Chulalongkorn Memorial Hospital
- Responsible party
- Principal investigator, Einapak Boontaveeyuwat, MD, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740983
- Sponsor's protocol ID
- 500/62
- Status last verified
- Feb 2021
- First submitted
- 23 May 2020
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Efficacy and Safety of UV Forecasting Based Heliotherapy For Psoriasis in Bangkok, Thailand: A Split-side Pilot Study
- ClinicalTrials.gov ID
- NCT04740983
- Acronym / sponsor ID
- 500/62
- Conditions
- Psoriasis Vulgaris
- Keywords
- Heliotherapy, sun-bathing, psoriasis, ultraviolet radiation, forecasting, Thailand
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- King Chulalongkorn Memorial Hospital
- Study start
- 15 Mar 2021 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Feb 2021 (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.
Due to limited number of phototherapy centres and shortage of qualified phototherapy practitioners, heliotherapy has become a promising treatment alternative in Thailand where patients effortlessly receive supervised sun-bathing treatments from their homes whenever they are convenient. We used newly designed deep neural network UV forecasting model developed by using our 10 year-retrospective Solar UV irradiance (280-400 nm) retrieved from a ground based platform at Atmosperic laboratory, Silpakorn University, Nakhon Pathom, Thailand (13.82N 100.04E, 30 m above mean sea level). This model achieved a next-day forecast error of less than 12% which has been the most accurate prediction to date. We designed our 10week heliotherapy regimen based on the predicted anti psoriasis effective irradiance values. We studied efficacy and safety of the 12-week heliotherapy regimen for psoriasis on only ruled acceptable clear sky days in Bangkok, Thailand
Detailed description
We studied efficacy and safety of the 16-week heliotherapy regimen for psoriasis on only ruled acceptable clear sky days in Bangkok, Thailand
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heliotherapy | Experimental | Other: Heliotherapy (a sole sun-bathing)will receive 16-week heliotherapy regimen based on the predicted anti psoriasis effective irradiance values along with olive oil (in-house formulation) |
| Control | No intervention | –only will receive olive oil (in-house formulation) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A psoriasis patient who indicate to have phototherapy and have lesional plagues systemically either on the front-back or left-right.
- A participant is based in Bangkok
- A participant is capable to understand and learn how to use our in-house assembled UV metre and web-based heliotherapy platform.
Key exclusion criteria (2 listed)
- A participant has any sun-sensitive conditions including photo-aggravated photodermatoses and on photosentisitive drug treatments.
- Breast-feeding, pregnant individuals.
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 |
|---|---|---|
| Heliotherapy (a sole sun-bathing)16-week heliotherapy regimen based on the predicted anti psoriasis effective irradiance values. | Other | Heliotherapy |
Primary outcome
Changes of Targeted PASI score
Time frame: 16 weeks
PASI score for targeted plagues will be evaluated by two independent dermatologists (EB, PA) from standard digital photographs.
1 secondary outcome
Incidence of possible acute side effects after sun bathing
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Heliotherapy (a sole sun-bathing) in people with Psoriasis Vulgaris, run by Chulalongkorn University.
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 3 inclusion and 2 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 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Changes of Targeted PASI score (time frame: 16 weeks). 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 5 Feb 2021.