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Recruiting NCT07055009

Multi-centred Clinico-genetic Study of Actinic Prurigo in Thailand

Observational Actinic Prurigo

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Targeted long-read HLA sequencing, RNA extraction, Full Skin examination.
Who it may be relevant to
Registry conditions: Actinic Prurigo. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This research project investigates the clinical and genetic associations of Actinic Prurigo (AP) in the Thai population. As a rare chronic photodermatosis, AP has been observed to occur more frequently in individuals with certain genetic predispositions, particularly specific Human Leukocyte Antigen (HLA) types. Previous studies have suggested variations in clinical presentation and HLA allele distributions between Asian and Western populations. The primary aim is to explore the relationship between clinical manifestations of AP and genetic profiles, including HLA typing, among Thai individuals. Additionally, the study seeks to examine whether different HLA types are associated with varying responses to treatment. The study design is a cross-sectional comparative study, involving both AP patients and age-matched healthy controls. Given the rarity of the condition, patient recruitment will be conducted across four collaborating institutions: King Chulalongkorn Memorial Hospital Siriraj Hospital Institute of Dermatology

Interventions

  • Diagnostic test Targeted long-read HLA sequencing
    Genetic study
  • Other RNA extraction
    Nanostring technology, Seattle
  • Other Full Skin examination
    Skin and mucosa examination

Primary outcome measures

  • Targeted long-read HLA sequencing [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (2)
  • Short-read whole genome sequencing (WGS) [Time frame: through study completion, an average of 1 year]
  • Immunology study [Time frame: through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • Thai ethnicity
  • Diagnosed with Actinic Prurigo (AP) according to the diagnostic criteria defined for this study
  • Mentally competent, able to communicate, and able to read Thai.
  • Participants receiving Thalidomide treatment must use two simultaneous methods of contraception, starting at least 4 weeks prior to initiating the medication and continuing throughout the treatment period and for at least 4 weeks after discontinuation.

Exclusion criteria

  • History and physical examination findings suggestive of other photodermatoses such as Lupus erythematosus, Porphyria, or Polymorphous Light Eruption, among others.
  • Elevated Epstein-Barr Virus (EBV) viral load detected in blood testing (EBV viral load will be tested in all participants).
  • Low Minimal Erythema Dose (MED) to UVB radiation as the only abnormal finding.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Thailand · 1 center
  • Faculty of Medicine Chulalongkorn University — Bangkok

Identifiers

NCT: NCT07055009 · CU41/2566

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗