Ultraviolet Radiation Forecasting Based Heliotherapy For Psoriasis in Bangkok, Thailand

NCT04740983 | Unknown DMC

• 1 other identifier: 500/62
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Conditions

Psoriasis Vulgaris

Keywords

Heliotherapy; sun-bathing; psoriasis; ultraviolet radiation; forecasting; Thailand

Outcome Measures

Primary Outcomes (1)

• Changes of Targeted PASI score

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

  16 weeks

Secondary Outcomes (1)

• Incidence of possible acute side effects after sun bathing

  16 weeks

Study Arms (2)

Heliotherapy

EXPERIMENTAL

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)

Control

NO INTERVENTION

only will receive olive oil (in-house formulation)

Interventions

Heliotherapy (a sole sun-bathing) OTHER

16-week heliotherapy regimen based on the predicted anti psoriasis effective irradiance values.

Heliotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chulalongkorn University: lead
• King Chulalongkorn Memorial Hospital: collaborator

MeSH Terms

Conditions

Psoriasis

Interventions

Heliotherapy

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant dermatologist, Dr.

Study Record Dates

• First Submitted: May 23, 2020
• First Posted: February 5, 2021
• Study Start: March 15, 2021
• Primary Completion: August 30, 2021
• Study Completion: December 31, 2021
• Last Updated: February 5, 2021

Record last verified: 2021-02