Psoriasis of the scalp
Conditions
Interventions
Experimental group 1:TAP-1502 Spray (1%)
Control group:Placebo
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 and above, male or female; 2. Clinically diagnosed as stable plaque psoriasis, the condition must have remained stable for at least 6 months before randomization, and scalp involvement must also be present; 3. The affected area of psoriasis on the scalp is = 3 points; 4. For psoriasis except on the scalp, the PGA score is <= 2, the affected body surface area (BSA) is <= 10%, and it is suitable for treatment with medium-potency or lower topical medications; 5. Fertile women of childbearing age with potential for fertility (including those who have had menarche and do not meet the criteria for no fertility potential) have a negative blood pregnancy test at the baseline screening and agree to take effective contraceptive measures during the study. Women with no fertility potential must meet at least one of the following criteria: a. Postmenopausal status, defined as at least 12 consecutive months of amenorrhea without other pathological or physiological causes; b. Have undergone hysterectomy and/or bilateral oophorectomy, with documented records; c. Medically confirmed ovarian failure; 6. Fully understand the content of the experiment, voluntarily participate in the experiment, and have signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with non-plaque psoriasis (such as erythrodermic psoriasis, pustular psoriasis, and psoriatic arthritis), those with progressive vulgar psoriasis, guttate psoriasis, and inverse psoriasis; 2. Those with severe diseases of the central nervous system, cardiovascular system, kidneys, liver, digestive tract, respiratory system, metabolism, and bone marrow and muscle system; 3. Those with serum alanine aminotransferase (ALT) and aspartate transaminase (AST) levels exceeding twice the upper limit of the normal range, or with serum creatinine levels exceeding 1.5 times the upper limit of the normal range for renal function; 4. Individuals with active human immunodeficiency virus (HIV) infection, active hepatitis C virus (HCV) infection (anti-HCV positive), active hepatitis B virus (HBV) infection (HBV-DNA > 2000 IU/mL or 1000 copies/mL), or positive Treponema pallidum antibody; 5. Women who are pregnant, breastfeeding, or planning to become pregnant; 6. Those who are allergic to the active ingredients or excipients of the investigational drug are known; 7. Subjects who have participated in any other drug clinical trials within 3 months prior to the first administration; 8. Exclude those with a history of alcohol abuse or drug abuse/dependence within the previous 12 months; 9. There are other serious skin diseases or skin problems in the scalp area that researchers believe would interfere with the assessment of scalp psoriasis, such as definite skin bacterial infections, viral infections, fungal infections, parasitic infections, seborrheic dermatitis, atopic dermatitis, etc., or there are pigmentation, large areas of scars, pigmented lesions, sunburn, etc. 10. Those who have used benvitimod cream for treatment in the past; 11. Has a history of malignant cancer or has received treatment for any type of malignant cancer within the past 5 years (except for skin squamous cell carcinoma, basal cell carcinoma or skin carcinoma in situ that were cured only by cryosurgery or surgical excision); 12. Those who had received biological agents known to affect scalp psoriasis (such as secukinumab, adalimumab, infliximab, etc.) before the baseline visit and had not reached the washout period of five half-lives after medication; 13. Those who had received ultraviolet phototherapy, photochemotherapy, excimer laser therapy or systemic treatments known to affect scalp psoriasis (including systemic glucocorticoids, retinoids, immunosuppressants, phosphodiesterase 4 inhibitors, traditional Chinese medicine, etc.) within 4 weeks before the baseline visit; 14. Those who received any local anti-psoriasis treatment on the scalp within 2 weeks before the baseline visit (including local use of glucocorticoids, vitamin D3 derivatives, retinoids, calcineurin inhibitors, etc.) or those who used medium-potency or higher topical psoriasis treatment drugs on areas other than the scalp within 2 weeks before the baseline visit (such as calcipotriol betamethasone compound cream, 1-4 grade topical glucocorticoids, etc.); 15. The subjects may be unable to complete this study for other reasons, or the researchers may consider them unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients with a scalp PGA of 0 or 1 and a decrease of at least 2 points from baseline (scalp PGA response rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of patients with a >=75% decrease from baseline in PSSI (PSSI 75 response rate);The longitudinal change value of the percentage change in PSSI score from baseline;The longitudinal change value of the PGA score of the scalp;The percentage change in visual analogue scale (VAS) for scalp pruritus from baseline; | — |
Countries
China
Contacts
Public ContactJianzhong Zhang
Peking University People's Hospital
Outcome results
None listed