Ultraviolet Radiation Forecasting Based Heliotherapy For Psoriasis in Bangkok, Thailand

February 2, 2021 updated by: Einapak Boontaveeyuwat, MD, Chulalongkorn University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heliotherapy
will receive 16-week heliotherapy regimen based on the predicted anti psoriasis effective irradiance values along with olive oil (in-house formulation)
Other: Heliotherapy (a sole sun-bathing)
16-week heliotherapy regimen based on the predicted anti psoriasis effective irradiance values.
No Intervention: Control
only will receive olive oil (in-house formulation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of possible acute side effects after sun bathing
Time Frame: 16 weeks
Potential acute effects of the exposure of full-spectrum solar radiation
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Collaborators

King Chulalongkorn Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2021

Primary Completion (Anticipated)

August 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

May 23, 2020

First Submitted That Met QC Criteria

February 2, 2021

First Posted (Actual)

February 5, 2021

Study Record Updates

Last Update Posted (Actual)

February 5, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 500/62

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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