Efficacy and Safety of Benvitimod Cream in the Retreatment of Mild to Moderate Psoriasis

NCT05326659 | Unknown

• 1 other identifier: TJ201808BWMD
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retreatment, multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the retreatment of mild to moderate stable psoriasis vulgaris in adults. Approximately 390 participants with mild to moderate stable psoriasis vulgaris will be enrolled and randomly divided into two groups in a 2:1 ratio. They will use either the Benvitimod cream or placebo at the skin with psoriasis vulgaris for 12 weeks.

Conditions

Psoriasis

Keywords

Benvitimod Cream; Psoriasis; Retreatment

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with ≥75% improvement in Psoriasis Area and Severity Index (PASI) score 12 weeks after retreatment with Benvitimod cream or placebo

  The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.

  Week 12

Secondary Outcomes (10)

• Proportion of participants with ≥90% improvement in Psoriasis Area and Severity Index (PASI) score 12 weeks after retreatment with Benvitimod cream or placebo

  Week 12

• Proportion of participants who Physician Global Assessment (PGA) score achieved 0 or 1 12 weeks after retreatment with Benvitimod cream or placebo

  Week 12

• Change of Psoriasis Area and Severity Index (PASI) score over time after retreatment with Benvitimod cream or placebo

  Week 12

• Change of erythema (redness), induration (plaque thickness), and scale score in the skin lesions over time after retreatment with Benvitimod cream or placebo

  Week 12

• Duration of remission after treatment response

  Week 12

Study Arms (2)

Benvitimod Cream

EXPERIMENTAL

Benvitimod cream, 1%, applied twice daily for 12 weeks after enrolment.

Drug: Benvitimod Cream

Placebo

PLACEBO COMPARATOR

Placebo, applied twice daily for 12 weeks after enrolment.

Drug: Placebo

Interventions

Benvitimod Cream DRUG

Benvitimod cream, 1%, applied twice daily for 12 weeks after enrolment.

Benvitimod Cream

Placebo DRUG

Placebo, applied twice daily for 12 weeks after enrolment.

Placebo

Eligibility Criteria

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

You may qualify if:

• Age 18\~65 years.
• Patients who were treated with Benvitimod cream and have discontinued medication were again diagnosed as suitable for treatment with Benvitimod cream.
• The participant with diagnosis of mild to moderate stable psoriasis vulgaris:
• BSA \< 10%.
• PGA ≥ 2.
• Capable of giving written informed consent.

You may not qualify if:

• ALT/AST \> 3 ULN, BUN/Cr \> 1.5 ULN.
• Skin lesions were limited to head，face and skin folds.
• Women who are pregnant, breast-feeding, or planning to become pregnant.
• Known to be allergic to active ingredients or any of the components of the drug.
• Alcoholic, or regular use of Chinese herbs or sedatives, sleeping pills, tranquilizers and other addictive drugs.
• Subjects who have other conditions that may interfere with the evaluation of the efficacy of psoriasis and/or other serious skin diseases other than psoriasis.
• Subjects who have serious diseases of the central nervous system, cardiovascular system, kidney, liver, digestive tract, respiratory system, metabolism and skeletal muscle system.
• Subjects who were considered unsuitable to participate in the study by the investigators.
• Received uv phototherapy, photochemotherapy, or systemic therapy (e.g., systemic glucocorticoid, methotrexate, retinoic acid, or cyclosporine) within 4 weeks prior to baseline visit.
• Received topical anti-psoriasis therapy (including topical glucocorticoids, retinoids, vitamin D analogues, or calcineurin inhibitors) within 2 weeks prior to baseline visit, except where the site of administration was not the target lesion after enrollment.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Zhonghao Pharmaceutical: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jianzhong Zhang

CONTACT

010-88325472; rmzjz@126.com

Lin Cai

CONTACT

13611236310; scailin66@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 13, 2022
• Study Start: April 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)