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Study for preliminary efficacy/safety and pharmacokinetics of benvitimod cream in the treatment by systemic exposure of Atopic Dermatitis

Study for preliminary efficacy/safety and pharmacokinetics of benvitimod cream in the treatment by systemic exposure of Atopic Dermatitis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026921
Enrollment
Unknown
Registered
2019-10-26
Start date
2019-05-08
Completion date
Unknown
Last updated
2019-10-28

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

Conditions

Atopic Dermatitis

Interventions

Case series:Two times a day for 20 consecutive days

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male and female patients aged over 18 years; 2. Clinical diagnosis of Atopic Dermatitis (Course of disease >=6 month, BAS 10% to 30%); 3. Have a baseline IGA of >=3; 4. Willing and able to comply with the protocol, provide written informed consent prior to the initiation of any study-related procedures.

Exclusion criteria

Exclusion criteria: 1. Pregnancy, lactation or who plan to be pregnant; 2. Any other skin diseases that may affectt the evaluation of the test results, or the presence of scars, fetal plaques tattoos, etc.in the affected area may affect the evaluation of skin lesions; 3. Skin lesions are confined to the hands and feet; 4. Obvious skin local bacterial,viruses and fungal infections; 5. The following therapists were used within the following time limitsbefore enrollment: (1) Using topic anti-inflammatory drugs within 2 weeks,(including glucocorticoid or calcineurin inhibitors such as atopic dermatitis treatment; (2) Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before the baseline visit and any phototherapy (including laser), photo-chemotherapy within four weeks prior to the baseline visit; 6. Have obvious heart,lung,gastrointestinal, liver, kidney, blood, nerve and mental illness,and the condition is unstable; 7. Suffering from mental illness, or other causes that may interfere with the trial; 8. A history of malignant tumors; 9. ALT or AST representing liver function is two times larger than the upper limit of normal value, or serum creatinine representing renal function, is higher than the upper limit of normal value; 10. Known or suspected hypersensitivity to any of the constituents of the investigational product; 11. Alcohol,drug addiction and drug dependence; 12. Treatment with other investigational drugs within three months of day 0 or current participation in another clinical trial; 13. The subjects may not participate the study because of other reasons, or whose researchers think are unsuitable for this study.

Design outcomes

Primary

MeasureTime frame
EASI;

Countries

China

Contacts

Public ContactJianzhong Zhang

Peking University People's Hospital

rmzjz@126.com+86 13552865791

Outcome results

None listed

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