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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The clinical signs of psoriasis (erythema, infiltration, and scaly) (The Total sign score (TSS))
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •<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;
排除标准
- •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.
研究组 & 干预措施
Boleda Supramolecular Active Zinc
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.
干预措施: Boleda Supramolecular Active Zinc Conditioner (Other)
Capotetriol scalp solution
30ml/bottle. Two times a day for 4 weeks, topically applied to scalp psoriasis.
干预措施: Capotetriol scalp solution (Drug)
Supramolecular Hydrogel
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.
干预措施: Supramolecular Hydrogel (Other)
结局指标
主要结局
The clinical signs of psoriasis (erythema, infiltration, and scaly) (The Total sign score (TSS))
时间窗: Change of sclinical signs of psoriasis from baseline at 4 weeks
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 1. = Mild 2. = Medium 3. = Severity 4. = 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).
Success rate at the end of treatment (4th week) in each group (percentage of patients with overall score of < 1)
时间窗: Change of success rate from baseline at 4 weeks
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.
次要结局
- Evaluation criteria of pruritus symptoms in the subjects(Change of spruritus symptoms from baseline at 4 weeks)
研究者
Gang Wang, MD
chief of dermatology
Xijing Hospital