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Observe the Efficacy and Safety of Dupilumab in Management of Refractory Prurigo Nodularis

Observe the Efficacy and Safety of Dupilumab in Management of Refractory Prurigo Nodularis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100047789
Enrollment
Unknown
Registered
2021-06-26
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prurigo nodularis

Interventions

Case series:No

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years; 2. Has typical clinical manifestation of prurigo nodularis; 3. Has suffered from prurigo nodularis for 3 months; 4. One week before treating with dupilumab, NRS>=7; 5. Number of nodular>=20; 6. Not response to topical corticosteroids, or has the contraindication of topical corticosteroids; 7. Has used emollients for one or two times for more than 5 days in the week before treatment; 8. The patient promise to record the symptoms everyday.

Exclusion criteria

Exclusion criteria: 1. Suffered from other dermatologic disease that might affect the evaluation of efficacy of treatment; 2. Nodularis prurigo induced by medications; 3. Nodularis prurigo induced by neuropathies or psychiatric diseases; 4. Has suffered from atopic dermatitis in 6 months; 5. Any other condition that could affect the efficacy of treatment or evaluation of the efficacy of treatment; 6. Abnormal renal function; 7. Uncontrolled thyroid diseases; 8. Active mycobacterial infection, or previous mycobacterial infection that has not undergone standard treatment; 9. Parasite infection; 10. Has suffered from active infection (e.g. bacterial infection, protozoan infection, viral infection, and fungal infection) in 2 weeks; 11. Immunodeficiency; 12. History of malignancy (except for cervical in situ carcinoma, cutaneous squamous cell carcinoma or basal cell carcinoma that have been cured).

Design outcomes

Primary

MeasureTime frame
Number of prurigo nodularis each time;Observe the adverse drug reactions caused by dupilumab;

Secondary

MeasureTime frame
The percentage of patients whose numerical rating scale decrease by not less than 4 at week 8;The percentage of patients whose numerical rating scale decrease by not less than 4 at week 16;The duration from onset of treatment with dupilumab to relief of symptoms.;

Countries

China

Contacts

Public ContactLian Cuihong

Shenzhen Second People's Hospital

15814692161@163.com+86 15814692161

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026