Evaluate the Efficacy and Safety of Boroda Supramolecular Active Zinc in the Treatment of Scalp Psoriasis

Study Overview
=================
Brief Summary
-----------------
A multicenter, randomized, single-blind, parallel-controlled clinical study to evaluate the efficacy and safety of boroda supramolecular active zinc in the treatment of scalp psoriasis. Main objective:：Compare the efficacy of boroda supramolecular active zinc and capotetriol liniment in the treatment of scalp psoriasis Secondary objective: To observe the safety of boroda supramolecular active zinc in the treatment of subjects with scalp psoriasis

Official Title
-----------------
A Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Study to Evaluate the Efficacy and Safety of Boroda Supramolecular Active Zinc in the Treatment of Scalp Psoriasis

Conditions
-----------------
Scalp Psoriasis

Intervention / Treatment
-----------------
* Other: Boleda Supramolecular Active Zinc Conditioner
* Drug: Capotetriol scalp solution
* Other: Supramolecular Hydrogel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18-65，regardless of gender； Clinically diagnosed as scalp psoriasis and severity of the disease： According to the researchers evaluation of clinical signs, each of the three clinical signs of scalp psoriasis, erythema, infiltration and scales, needs to be < 3 points, and at least one sign score is ≥ 1. <25% of the total scalp area (the fully expanded flat palm (including the surface of five fingers) is equivalent to approximately 25% of the scalp area). The judgment of mild to moderate outcome need to be in accordance with the overall evaluation criteria; At the time of admission, the skin lesions of the body and limbs of the subjects need to have clinical signs of psoriasis vulgaris (the maximum surface of the affected area is ≤10%) or had been diagnosed as psoriasis vulgaris on the body and limbs at the early stage. Subjects must sign a informed consent of notification in prior to the study; Exclusion Criteria: Subjects are diagnosed with active guttate psoriasis, pustular psoriasis, arthropathy psoriasis and erythroderma psoriasis at present. The subjects scalp associated with other diseases that may affect the judgment of curative effect: such as, viral infection, fungal infection, bacterial infection, parasitic infection, skin manifestations associated with syphilis or tuberculosis, rosacea, acne, post-acne inflammation, skin atrophy, atrophic stria, increased skin venous vulnerability, ichthyosis, ulcer or wound that skin manifestations related to injury; Any infectious skin disease that confuses the evaluation of the efficacy of scalp psoriasis The subjects that had received systemic biotherapy (listed or not listed) in the past three months of randomized enrollment that may have potential effects on scalp psoriasis, such as alefaxer, legalizumab, etanercept, infliximab, etc. The subjects who had received non-biological systemic therapies that may have an impact on scalp psoriasis, such as corticosteroids, vitamin D-type drugs, Tretinoin, immunosuppressive agents, etc. in 4 weeks before the 2nd screening visit or during the study period. Randomly enrolled (1st visit) subjects who have received PUVA treatment 4 weeks before or during the study period; Randomly enrolled (1st visit) subjects that had received ultraviolet therapy 2 weeks before or during the study period; The subjects that had received the following treatments 2 weeks before the 2nd screening or during the study period: Strong or extremely effective steroid hormone external preparations for psoriasis on the body and limbs (WHO Class III-IV); External immunomodulators (such as tacrolimus ointment, etc.) External use of vitamin D analogues (e.g. captopril preparation, tacalcitol and calcitriol); External treatment of various types of scalp psoriasis (except for shampoos or softeners that are not steroid drugs); Other treatments for psoriasis: such as traditional Chinese medicine or Chinese patent medicine, hot springs, etc. During the study period, it is planned to start or change the use of concomitant drugs that may affect scalp psoriasis, such as beta-blockers, antimalarials, lithium preparations, etc. Subjects who are known or suspected to be allergic to the drug components in the study; Pregnant or fertile female intend to be pregnant or lactating during the study period; In the 2nd screening visit, the serum or urine pregnancy test of fertile women is positive. The subjects who participated in other clinical trials within 4 weeks of randomization; The subjects with known or suspected poor compliance who could not complete the tests, such as alcoholism, drug dependence or mental illness, or the subjects who are not suitable to participate in this clinical research that determined by the researchers.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Boleda Supramolecular Active Zinc<br>Boleda Supramolecular Active Zinc (Shanghai Ruizhi Pharmaceutical Technology Co., Ltd.): 30ml/bottle. Once a day for 4 weeks, apply topically to the scalp psoriasis area, gently massage for 15 minutes then rinse off with warm water. | Other: Boleda Supramolecular Active Zinc Conditioner<br>* Boleda Supramolecular Active Zinc Conditioner (Shanghai Ruizhi Pharmaceutical Technology Co., Ltd.): 30ml/bottle. Once a day for 4 weeks, apply topically to the scalp psoriasis area, gently massage for 15 minutes then rinse off with warm water.<br>|
| Active Comparator: Capotetriol scalp solution<br>30ml/bottle. Two times a day for 4 weeks, topically applied to scalp psoriasis. | Drug: Capotetriol scalp solution<br>* Capotetriol scalp solution: 30ml/bottle. Two times a day for 4 weeks, topically applied to scalp psoriasis.<br>|
| Placebo Comparator: Supramolecular Hydrogel<br>30ml/bottle. Once a day for 4 weeks, apply topically to the scalp psoriasis area, gently massage for 15 minutes then rinse off with warm water. | Other: Supramolecular Hydrogel<br>* Supramolecular Hydrogel (Shanghai Ruizhi Pharmaceutical Technology Co., Ltd.): 30ml/bottle. Once a day for 4 weeks, apply topically to the scalp psoriasis area, gently massage for 15 minutes then rinse off with warm water.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate at the end of treatment (4th week) in each group (percentage of patients with overall score of < 1) | The overall criteria for assessing the severity of disease for researchers are a static skin scoring system consisting of six levels (score of 0-5) of change from disappearance to very serious diseases. The main endpoint of the overall assessment criteria for disease severity according to the researchers will be disease control, defined as disappearance (score of 0)  or extreme mild (score of 1)  disease grade at the end of treatment. At the end of treatment, the proportion of the subjects who are evaluated as disease under control (signs disappeared and extremely mild) by the overall assessment of the severity of disease by researchers base on observation. Comparing the disease control rates among the groups can reflect the differentiation treatment efficacy. | Change of success rate from baseline at 4 weeks | 
| The clinical signs of psoriasis (erythema, infiltration, and scaly) (The Total sign score (TSS)) | Scoring each symptom once on the basis of the five-point system given below can assess the average severity of all scalp lesions. 0 = no sign = Mild = Medium = Severity = Extremely severe At the end of treatment, researchers need to evaluate scalp psoriasis in all subjects from three aspects: erythema, infiltration and scales. The percentage of remission per clinical sign (erythema, infiltration, scales) in each group (percentage of patients with clinical score = 0). | Change of sclinical signs of psoriasis from baseline at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation criteria of pruritus symptoms in the subjects | At the end of treatment, the subject are assessed for the severity of the disease according to the four-level system presented below. Researchers should explain the grading criteria to patients, and the subjects should judge the grading and tick it. Asymptomatic: no itching; Mild: mild itching, no irritation; Moderate: markedly itchy, somewhat irritable, but no insomnia; Severe: Strong itching causes significant irritability, affects sleep, and scratches are visible. | Change of spruritus symptoms from baseline at 4 weeks |