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Ultraviolet Radiation Forecasting Based Heliotherapy For Psoriasis in Bangkok, Thailand

Primary Purpose

Psoriasis Vulgaris

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Heliotherapy (a sole sun-bathing)
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring Heliotherapy, sun-bathing, psoriasis, ultraviolet radiation, forecasting, Thailand

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • A participant has any sun-sensitive conditions including photo-aggravated photodermatoses and on photosentisitive drug treatments.
  • Breast-feeding, pregnant individuals.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Heliotherapy

    Control

    Arm Description

    will receive 16-week heliotherapy regimen based on the predicted anti psoriasis effective irradiance values along with olive oil (in-house formulation)

    only will receive olive oil (in-house formulation)

    Outcomes

    Primary Outcome Measures

    Changes of Targeted PASI score
    PASI score for targeted plagues will be evaluated by two independent dermatologists (EB, PA) from standard digital photographs.

    Secondary Outcome Measures

    Incidence of possible acute side effects after sun bathing
    Potential acute effects of the exposure of full-spectrum solar radiation

    Full Information

    First Posted
    May 23, 2020
    Last Updated
    February 2, 2021
    Sponsor
    Chulalongkorn University
    Collaborators
    King Chulalongkorn Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04740983
    Brief Title
    Ultraviolet Radiation Forecasting Based Heliotherapy For Psoriasis in Bangkok, Thailand
    Official Title
    The Study of Efficacy and Safety of UV Forecasting Based Heliotherapy For Psoriasis in Bangkok, Thailand: A Split-side Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 15, 2021 (Anticipated)
    Primary Completion Date
    August 30, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chulalongkorn University
    Collaborators
    King Chulalongkorn Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis Vulgaris
    Keywords
    Heliotherapy, sun-bathing, psoriasis, ultraviolet radiation, forecasting, Thailand

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Heliotherapy
    Arm Type
    Experimental
    Arm Description
    will receive 16-week heliotherapy regimen based on the predicted anti psoriasis effective irradiance values along with olive oil (in-house formulation)
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    only will receive olive oil (in-house formulation)
    Intervention Type
    Other
    Intervention Name(s)
    Heliotherapy (a sole sun-bathing)
    Intervention Description
    16-week heliotherapy regimen based on the predicted anti psoriasis effective irradiance values.
    Primary Outcome Measure Information:
    Title
    Changes of Targeted PASI score
    Description
    PASI score for targeted plagues will be evaluated by two independent dermatologists (EB, PA) from standard digital photographs.
    Time Frame
    16 weeks
    Secondary Outcome Measure Information:
    Title
    Incidence of possible acute side effects after sun bathing
    Description
    Potential acute effects of the exposure of full-spectrum solar radiation
    Time Frame
    16 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: A participant has any sun-sensitive conditions including photo-aggravated photodermatoses and on photosentisitive drug treatments. Breast-feeding, pregnant individuals.

    12. IPD Sharing Statement

    Learn more about this trial

    Ultraviolet Radiation Forecasting Based Heliotherapy For Psoriasis in Bangkok, Thailand

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