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

NCT06524323 | Not Yet Recruiting Phase 3

• 1 other identifier: 2024-0042
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 5-fluorouracil plus triamcinolone acetonide.

Conditions

Nodular Prurigo

Keywords

nodular prurigo; 5-fluorouracil

Outcome Measures

Primary Outcomes (2)

• Clearance rate

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

  Week 12 after administration

• NRS score

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

  Week 12 after administration

Study Arms (2)

Control side

OTHER

Intralesional injection of triamcinolone acetonide alone

Drug: Triamcinolone Acetonide

Experimental side

EXPERIMENTAL

Intralesional injection of 5-fluorouracil plus triamcinolone acetonide

Drug: 5-fluorouracil Injection

Interventions

5-fluorouracil Injection DRUG

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

Experimental side

Triamcinolone Acetonide DRUG

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

Control side

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Fully understand and voluntarily sign an informed consent form for this experiment;
• \) When signing the informed consent form, the age of male or female participants is ≥ 18 years old and ≤ 70 years old;
• \) 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;
• \) Within the 12 weeks before screening, no intralesional injection of triamcinolone acetonide or 5-FU combined with triamcinolone acetonide treatment was received;
• \) 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;
• 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;
• \) Multiple symmetrically distributed nodules (10-12 nodules on one side) were observed in the trunk and limbs during subject screening;
• \) During the subject screening, the Pruritus Numerical Rating Scale (NRS) score was ≥ 4 points;
• \) 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:
• \) The subjects can communicate well and agree to comply with the study and follow-up procedures.

You may not qualify if:

• \) 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;
• \) Known or suspected allergy to 5-fluorouracil and its analogs;
• \) Have received aspirin drugs within the first week before screening and need to be taken for a long time, and should not be discontinued;
• \) 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;
• 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;
• \) 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;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Interventions

Fluorouracil; Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)