Psoriasis Trial, Recruiting NCT07021495 Sponsor: Leiden University Medical Center Condition: Psoriasis
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Psoriasis Trial, Recruiting

NCT07021495
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For patients with skin conditions (general requirements):

  • People who are able to understand and sign a written consent form before any study procedures begin
  • People who are male or non-pregnant female, aged 18 or older
  • People who are willing to avoid extensive washing, bathing, or swimming of the affected skin area for 12 hours before each study visit
  • People who are willing and able to follow the study schedule and requirements
  • Female participants who are willing to avoid becoming pregnant from the start of the study until the last visit (month 12)
  • People who are willing to begin the treatment prescribed as part of the study

For people with Atopic Dermatitis (eczema):

  • People with a confirmed diagnosis of chronic, moderate-to-severe eczema (meeting standard diagnostic criteria) for at least 3 years before joining
  • People who have recent records (within the last 6 months) showing their condition was serious enough to warrant treatment with immune-suppressing medicines, biologics, or JAK-inhibitor medicines
  • People who have recent records (within the last 6 months) showing that previous treatments did not work well enough, where applicable
  • People with a disease severity score (EASI) of 7 or higher at the time of joining
  • People who have at least one suitable affected skin area identified by the study doctor
  • People who are about to start treatment with one of the following medicines: cyclosporine A, dupilumab, tralokinumab, lebrikizumab, abrocitinib, or upadacitinib

For people with Cutaneous Lupus Erythematosus (CLE — a form of lupus affecting the skin):

  • People with a confirmed diagnosis of CLE (including SCLE, CDLE, or LET types), confirmed through skin examination and laboratory testing
  • People with a disease activity score (CLASI-A) of 3 or higher, not counting hair loss or mouth ulcers
  • People who are about to start treatment with topical corticosteroids, hydroxychloroquine, or methotrexate (alone or in combination)

For people with Chronic Spontaneous Urticaria (CSU — long-term hives with no clear cause):

  • People with a confirmed diagnosis of moderate-to-severe CSU lasting at least 3 months, whose symptoms continue despite taking second-generation antihistamine tablets (at up to four times the standard approved dose)
  • People currently taking antihistamines who have been on a stable dose for at least 2 weeks before the study starts, and who are willing to keep that dose the same throughout the study
  • People who are about to start treatment with omalizumab, cyclosporine A, or a BTK inhibitor (where that medicine is approved and covered by health insurance in the Netherlands)

For people with Hidradenitis Suppurativa (HS — a skin condition causing painful lumps):

  • People with a history of moderate-to-severe HS (based on a standard scoring system) for at least 1 year before joining
  • People who are about to start treatment with anti-TNF or anti-IL17 medicines (such as secukinumab or bimekizumab, where approved and covered in the Netherlands)

For people with Mycosis Fungoides (MF — a type of skin lymphoma):

  • People with a confirmed diagnosis of cutaneous T-cell lymphoma (CTCL), MF type, confirmed through tissue sampling or clinical assessment
  • People in early stages (IA–IIA) who have at least one patch or plaque lesion present
  • People who are about to start treatment with topical chlormethine, topical corticosteroids, or light therapy (PUVA or UV-B)

For people with Psoriasis (PSO):

  • People with a confirmed diagnosis of chronic plaque psoriasis for at least 6 months before joining
  • People with a psoriasis severity score (PASI) of 5 or higher, with at least one suitable affected skin area identified by the study doctor
  • People who are about to start treatment with a biologic medicine, including anti-TNF, anti-IL23, anti-IL17, or anti-TYK2 medicines

For healthy volunteers:

  • People who are male or non-pregnant female, aged 18 or older
  • People who are in stable good health, as assessed by the study doctor
  • People with no significant skin disease, as judged by the study doctor
  • People with no history of raised or thickened scarring (hypertrophic scarring or keloid)
  • People willing to avoid extensive washing or bathing of the study skin area for 12 hours before each visit
  • People willing to stop using any skin treatments (prescription or over-the-counter) on the study area for 2 weeks before the study starts
  • People willing to avoid applying any skin products (creams, ointments, lotions) to the skin 24 hours before each study visit
  • People willing to stop any antibiotic treatment for 14 days before the study starts
  • People willing and able to follow the full study schedule
  • Female participants who are willing to avoid becoming pregnant from the start of the study until the last visit

Who may not be able to join:

For patients (general):

  • People who have another skin infection or skin disease in the area being studied, other than their main condition
  • People who have taken an unapproved experimental drug within 4 weeks before joining
  • People who have any other condition or health factor that the study doctor believes could interfere with the study
  • People who have recently used certain treatments within the preferred washout period (confirm with trial site): topical treatments within 1 week; light therapy within 4 weeks; non-biologic systemic treatments within 4 weeks; radiotherapy or surgery in the treatment area within 8 weeks; biologic medicines within 8 weeks; chemotherapy within 3 months — note that these are preferred waiting periods and are not strict exclusion rules, as this is a real-world study

For people with CLE specifically:

  • People who have been diagnosed with systemic lupus erythematosus (SLE — lupus affecting internal organs)

For people with CSU specifically:

  • People who have received omalizumab within 8 weeks before the study starts
  • People whose hive or swelling symptoms are caused by other specific conditions, such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis, or inherited or drug-induced angioedema (confirm with trial site)

For people with MF specifically:

  • People with an ongoing, uncontrolled active skin infection (other than a secondary infection of MF lesions, as judged by the study doctor)

For people with Psoriasis specifically:

  • People whose psoriasis is primarily of the erythrodermic, pustular, or guttate type
  • People with psoriasis that was caused by a medication

For healthy volunteers:

  • People with a history of immune system problems, such as immune suppression, severe allergies, or anaphylaxis, that the study doctor believes could affect the study
  • People with any significant uncontrolled health condition (such as neurological, psychiatric, heart, lung, digestive, liver, or kidney conditions) that the study doctor believes could affect the study
  • People who have used systemic antibiotic treatment for more than 2 months in total during the past 12 months
  • People who have used any immune-suppressing or immune-modifying treatment within the 30 days before the study starts
  • People who have donated or lost more than 500mL of blood in the 3 months before joining, or who have participated in another drug study within 3 months before joining or more than 4 times in the past year
  • People who have been drinking more than 5 standard alcoholic drinks per day on average in the 3 months before joining; alcohol must also be avoided for at least 24 hours before each study visit
  • People who test positive for drugs in a urine test at the start of the study, or who have a history of drug misuse
  • People who have had high levels of UV (sun or sunbed) exposure within 3 weeks before the first visit, or who cannot avoid this during the study
  • People who have done intense physical exercise within 48 hours before any study visit
  • People with any other condition or known factor that the study doctor believes could interfere with the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +31 71 526 9111

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Leiden University Medical Center
Registry
ClinicalTrials.gov
Start date
29 July 2025
Est. completion
31 December 2029

Where this trial is recruiting

🇳🇱 Netherlands

Primary endpoints

Lipidomics of the stratum corneum and OLINK; Cutaneous microbiome; Serum biomarkers; Plasma biomarkers; Eczema Area and Severity Index (EASI); objective Severity Scoring of Atopic Dermatitis (oSCORAD); Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD); Cutaneous LE Disease Area and Severity Index Activity (CLASI-A); Total Sum Score; The Cutaneous Lupus Activity-Investigator Global Assessment (CLA-IGA); International Hidradenitis Suppurativa Severity Score System (IHS4); Modified Severity-Weighted Assessment Tool (mSWAT); Cutaneous Lymphoma Activity and Severity Ind...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov