Actinic PrurigoNCT07055009
Multi-centred Clinico-genetic Study of Actinic Prurigo in Thailand
An observational study of Actinic Prurigo, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Actinic Prurigo
- What is being tested?
- Targeted long-read HLA sequencing, RNA extraction and Full Skin examination
- How many people
- 47 participants
- Where
- 1 siteThailand
- Study dates
- 30 Mar 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Actinic Prurigo (AP)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Chulalongkorn University
Bangkok
Kittima Leklad, +6622564253, kittima.l@chula.ac.th
About this study
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.
Read more
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
- Conditions
- Actinic Prurigo
- Being tested
- Targeted long-read HLA sequencing, RNA extraction, Full Skin examination
- Keywords
- Actinic prurigo, subtype actinic prurigo, HLA typing, genetic
- Medical subject headings
- Actinic Prurigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted long-read HLA sequencingDiagnostic test
Also called Short-read whole genome sequencing
Genetic study
RNA extractionOther
Nanostring technology, Seattle
Full Skin examinationOther
Skin and mucosa examination
| Study group | Role | What they receive |
|---|---|---|
| Case | Not described Receives: Diagnostic Test: Targeted long-read HLA sequencing; Other: RNA extraction; Other: Full Skin examination | |
| Control | Not described Receives: Diagnostic Test: Targeted long-read HLA sequencing; Other: RNA extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Targeted long-read HLA sequencing
Correlation between the occurrence of Actinic Prurigo (AP), its clinical manifestations, and genetic factors-including HLA types-in individuals of Thai ancestry.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Short-read whole genome sequencing (WGS)
Correlation between the occurrence of Actinic Prurigo (AP), its clinical manifestations, and genetic factors-including short-read whole genome sequencing (WGS)-in individuals of Thai ancestry.
Measured: through study completion, an average of 1 year
Immunology study
Correlation between the occurrence of Actinic Prurigo (AP), its clinical manifestations, and immunological factors in individuals of Thai ancestry, measured by RNA extraction and gene expression analysis.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start30 Mar 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic PrurigoStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Systems Research Institute,Thailand
- Responsible party
- Principal investigator, Einapak Boontaveeyuwat, MD, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055009
- Sponsor's protocol ID
- CU41/2566
- Status last verified
- May 2026
- First submitted
- 4 Jun 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centred Clinico-genetic Study of Actinic Prurigo in Thailand
- ClinicalTrials.gov ID
- NCT07055009
- Acronym / sponsor ID
- CU41/2566
- Conditions
- Actinic Prurigo
- Keywords
- Actinic prurigo, subtype actinic prurigo, HLA typing, genetic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Health Systems Research Institute,Thailand
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jul 2025 (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.
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
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Diagnostic Test: Targeted long-read HLA sequencing, Other: RNA extraction, Other: Full Skin examination |
| Control | – | Diagnostic Test: Targeted long-read HLA sequencing, Other: RNA extraction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Actinic Prurigo (AP)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Targeted long-read HLA sequencingAlso: Short-read whole genome sequencingGenetic study | Diagnostic test | Case, Control |
| RNA extractionNanostring technology, Seattle | Other | Case, Control |
| Full Skin examinationSkin and mucosa examination | Other | Case |
Primary outcome
Targeted long-read HLA sequencing
Time frame: through study completion, an average of 1 year
Correlation between the occurrence of Actinic Prurigo (AP), its clinical manifestations, and genetic factors-including HLA types-in individuals of Thai ancestry.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Actinic Prurigo, run by Chulalongkorn University at 1 site in Thailand.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Einapak Boontaveeyuwat, MD (+66922995700, einapak.b@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Targeted long-read HLA sequencing (time frame: through study completion, an average of 1 year). 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 12 May 2026.