A Randomized Controlled Study on the Combined and Sequential Optimal Plan of Traditional Chinese Medicine Internal and External Therapy for Psoriasis

Phase 4

• Conditions: Psoriasis

• Registration Number: ITMCTR2000003594
• Lead Sponsor: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Have plaque psoriasis; the course of the disease is not limited;
2. Have skin lesions covering <= 10% of the BSA (should be mainly located on the trunk and/or limbs, palms/soles, face/scalp; the vulva area should not be included);
3. Aged between 18 and 70 years;
4. Provide informed consent.

Exclusion Criteria

1. Patients with other active skin diseases that may affect condition assessment;
2. Patients who have received systematic treatment with research drugs, biological agents, or immunosuppressive agents within 2 months prior to screening;
3. Patients who have received treatment with topical glucocorticoids, retinoic acid, or phototherapy, within 2 weeks prior to screening;
4. Patients with severe, uncontrollable local, or systemic acute or chronic infections;
5. Patients with severe systemic diseases or any of the following clinical test indicators: an increase in alanine transferase or glutamate transferase level of > 1.5 times the upper limit of normal or an increase in serum creatinine level of > 1.5 times the upper limit of normal. Patients with any of the main standard blood indicators (i.e., white blood cell count, red blood cell count, hemoglobin level, and platelet count) below the lower limit of normal, or those with other laboratory abnormalities, as judged by the investigators, will be excluded;
6. Patients with a history of malignant tumors or primary/secondary immunodeficiency and hypersensitivity.
7. Patients who have undergone a major surgery within 8 weeks of treatment or will require such surgery during the study period;
8. Patients who are pregnant or lactating;
9. Patients with a history of alcohol or drug abuse;
10. Patients with a history or family history of a serious mental illness;
11. Patients with a family history of cancer;
12. Patients who were judged by the investigators to be unsuitable for inclusion in the study for and other reasons.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified