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Nodular PrurigoPhase 3NCT06524323

A Randomized, Double-blinded, Self-controlled Clinical Study of Intralesional Injection of 5-fluorouracil Plus Triamcinolone for the Treatment of Refractory Nodular Prurigo

A Phase 3 study testing 5-fluorouracil Injection and Triamcinolone Acetonide in people with Nodular Prurigo, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Nodular pruritus is a chronic inflammatory skin disease manifested as individual or multiple highly keratotic nodules with severe itching. The goal of this clinical trial is to compare the efficacy and safety of treating refractory nodular pruritus with intralesional injections of 5-fluorouracil alone or… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nodular Prurigo
What is being tested?
5-fluorouracil Injection and Triamcinolone Acetonide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Sep 2024to 31 Aug 2026
Phase
Phase 3
Are there results?
None posted in the registry

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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1) Fully understand and voluntarily sign an informed consent form for this experiment;
  • 2) When signing the informed consent form, the age of male or female participants is ≥ 18 years old and ≤ 70 years old;
  • 3) During the screening of subjects, the onset time of nodular prurigo was at least 6 months, and it met the diagnostic criteria for nodular prurigo;
  • 4) Within the 12 weeks before screening, no intralesional injection of triamcinolone acetonide or 5-FU combined with triamcinolone acetonide treatment was received;
  • 5) Within the specified time window before screening, there is a clear medical history showing that patients who have received any of the following treatment regimens can partially alleviate nodular prurigo but have not been completely cleared:
  • Continuous use of systemic therapies such as antihistamines, antiepileptic drugs (gabapentin, pregabalin, etc.), glucocorticoids, or immunosuppressants (methotrexate, cyclosporine, thalidomide, etc.) for the first 4 weeks before screening;
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  • Continuous use of small molecule inhibitors (including tofacitinib/tofacitinib, baritinib/baritinib, Upadacitinib/Upatinib, Abrocitinib/Abrocitinib, ruxolitinib/Lucetinib, filgotinib/Figetinib, lestaurtinib/letatinib, pacritinib/parkatinib, Delgocitinib, SHR0302, etc.) for the first 4 weeks before screening;
  • Continuous use of biologics (including monoclonal antibodies targeting IL-4, IL-13, IL-31, IgE, etc.) for the first 8 weeks before screening;
  • Continuous use of phototherapy (such as UVB, PUVA, etc.) for the first 4 weeks before screening;
  • 6) From the start of screening until the end of the visit, the subject can only continue to use moisturizers and the treatment regimens listed in the Inclusion Criteria 5;
  • 7) Multiple symmetrically distributed nodules (10-12 nodules on one side) were observed in the trunk and limbs during subject screening;
  • 8) During the subject screening, the Pruritus Numerical Rating Scale (NRS) score was ≥ 4 points;
  • 9) For women with reproductive ability and all male subjects, abstinence or contraception must be maintained during the trial period and for 6 months after discontinuation of the trial drug:
  • 10) The subjects can communicate well and agree to comply with the study and follow-up procedures.

Who cannot join

  • 1) Have other inflammatory skin diseases (such as psoriasis), as well as any abnormal skin changes that may affect the evaluation of treatment response for nodular prurigo;
  • 2) Known or suspected allergy to 5-fluorouracil and its analogs;
  • 3) Have received aspirin drugs within the first week before screening and need to be taken for a long time, and should not be discontinued;
  • 4) Within the specified time window before the first administration, individuals with the following infection status:
  • Patients with active tuberculosis (TB), latent untreated TB, or a history of TB or non-tuberculous mycobacterium infection with potential incomplete treatment within 48 weeks before screening, or patients with TB screening indicating latent TB infection;
  • The following infections that are active and uncontrolled during screening: HIV positive, active syphilis, HBsAg positive for hepatitis B with HBV-DNA detection values exceeding the lower limit of quantification, positive anti-HCV antibodies or HCV-RNA positive for hepatitis C;
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  • Screening for bacterial, viral, mycoplasma, parasitic, protozoan, or fungal infections with any clinical symptoms within the first two weeks that require systemic anti-infection treatment, or screening for individuals with active lung infections indicated by chest imaging examination;
  • Screening for individuals with a history of herpes simplex virus or varicella-zoster virus infection within the first 4 weeks, or those with superficial skin infections that require treatment within the first week but have not recovered;
  • 5) Individuals with the following serious chronic or acute diseases that have not been controlled:
  • Have a clear history of arterial or venous thromboembolism within the first 12 weeks of randomization, or have a high-risk state that requires long-term use of anticoagulants to prevent thrombosis;
  • Individuals with severe heart disease within the first 12 weeks of randomization, including myocardial infarction, heart failure (grade III or IV according to the NYHA classification), history of unstable angina, or third-degree atrioventricular block and other life-threatening arrhythmias;
  • Individuals who have experienced severe trauma or major surgery within the first 4 weeks of randomization;
  • Serious neurological disorders were present during screening, including acute cerebrovascular diseases within the first 6 months of randomization, previous seizures within the first 4 weeks of randomization or the need for continuous anti-epileptic drug treatment, known or suspected demyelinating neurological disorders during screening, peripheral neuropathy with CTCAE V5.0 ≥ 2, and any significant neurological dysfunction remaining;
  • During screening, there were severe mental illness patients, including any severe/unstable mental/psychological illness or somatic illness/symptoms, as well as recent or current suicidal thoughts or behaviors, as well as other researchers who believed they would pose an unacceptable risk to participants in the study, except for those with mild emotional disorders caused by nodular prurigo who do not require antipsychotic or sedative maintenance therapy;
  • When screening, individuals with known or suspected immunodeficiency diseases, first-degree relatives with hereditary immunodeficiency diseases, or those who have received organ transplants that require sustained immunosuppression;
  • There is known or suspected leukopenia during screening;
  • Individuals with a known or suspected history of thrombocytopenia, coagulation disorders, or platelet dysfunction during screening;
  • Have other serious and uncontrolled diseases, including severe lung, liver, kidney, endocrine and metabolic, lymphatic system, autoimmune and connective tissue diseases, etc;
  • 6) Have the following events within the specified time window before the first administration of the investigational drug:
  • Individuals with a history of drug abuse, alcohol abuse, or addiction, including those who frequently (>3 times per week) use sedatives, sleeping pills, or tranquilizers;
  • Individuals who have received any clinical trial treatment of drugs or medical devices within the first 4 weeks of randomization;
  • When screening, there is a clear plan to undergo major surgeries during the study period, or significant changes in work and life status that may affect compliance with the study;
  • 7) During screening or baseline visits, laboratory tests did not meet the following criteria:
  • Blood routine: WBC count ≥ lower limit of normal (LLN), neutrophil count ≥ LLN, lymphocyte count ≥ LLN, platelet count ≥ 100 × 109/L, hemoglobin ≥ 100g/L;
  • Liver function indicators: ALT<2.0 x ULN, AST<2.0 x ULN, total bilirubin<1.5 x ULN;
  • Renal function indicators: glomerular filtration rate (eGFR) ≥ 60 ml/min/1.73 m2;
  • Blood glucose: Fasting blood glucose<8.9mmol/L (allowed to be controlled by hypoglycemic drugs);
  • Blood pressure: systolic blood pressure<160mmHg and/or diastolic blood pressure<100mmHg (allowed to be controlled by no more than two antihypertensive drugs);
  • Coagulation function indicators: PT<1.5 x ULN, APTT<1.5 x ULN, INR<1.5;
  • 12 lead electrocardiogram QTc<480ms, cardiac ultrasound LVEF ≥ lower limit of normal value;
  • 8) The researchers believe that any other subjects who are unsuitable to participate in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310000

Other trials in China

About this study

Nodular pruritus is a chronic inflammatory skin disease manifested as individual or multiple highly keratotic nodules with severe itching. The goal of this clinical trial is to compare the efficacy and safety of treating refractory nodular pruritus with intralesional injections of 5-fluorouracil alone or 5-fluorouracil plus triamcinolone acetonide.

Read the detailed description

The study is a single-center, randomized, double-blinded, self-controlled clinical trial and is expected to enroll 60 patients. The trial is set up with a self-control design, comparing the two treated sides on the arms or legs with 1:1 interindividual randomization (right side: triamcinolone acetonide-alone; left side: 5-fluorouracil plus triamcinolone acetonide; or the other way round). Patients who meet all the inclusion criteria and do not meet any of the exclusion criteria are randomly enrolled and receive trial medication treatment. All enrolled patients with receive intralesional injections of the trial medication once every 4 weeks for a total of 12 weeks. For the first 4 weeks after the initial dose, follow-up visits are scheduled every 2 weeks; from weeks 5 to 12, follow-up visits are scheduled every 4 weeks.

Conditions
Nodular Prurigo
Being tested
5-fluorouracil Injection, Triamcinolone Acetonide
Keywords
nodular prurigo, 5-fluorouracil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5-fluorouracil InjectionDrug

    The mixture contains 2mL of triamcinolone acetonide injection and 4mL of 5-fluorouracil injection, which is diluted with saline to 10mL.

  • Triamcinolone AcetonideDrug

    The mixture contains 2mL of triamcinolone acetonide injection which is diluted with saline to 10mL.

Study groups in NCT06524323
Study groupRoleWhat they receive
Control sideOtherIntralesional injection of triamcinolone acetonide alone
Receives: Drug: Triamcinolone Acetonide
Experimental sideExperimentalIntralesional injection of 5-fluorouracil plus triamcinolone acetonide
Receives: Drug: 5-fluorouracil Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clearance rate

    The proportion of subjects with a clearance rate of ≥ 90%

    Measured: Week 12 after administration

  2. NRS score

    The proportion of subjects whose NRS score improved by ≥ 4 points from baseline

    Measured: Week 12 after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06524323
Sponsor's protocol ID
2024-0042
Status last verified
Jul 2024
First submitted
23 Jul 2024
Last updated
29 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 5-fluorouracil Injection and Triamcinolone Acetonide in people with Nodular Prurigo, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

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 14 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 29 Jul 2024. 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 China. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clearance rate (time frame: Week 12 after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06524323.

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 29 Jul 2024.

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