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

2021년 3월 15일 업데이트: Gang Wang, MD, Xijing Hospital

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

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

연구 개요

연구 유형

중재적

등록 (실제)

240

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Shaanxi
      • Xi'an, Shaanxi, 중국, 710032
        • Dermatology Derpartment of Xijing Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Age between 18-65,regardless of gender;
  2. 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;
  3. 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.
  4. Subjects must sign a informed consent of notification in prior to the study;

Exclusion Criteria:

  1. Subjects are diagnosed with active guttate psoriasis, pustular psoriasis, arthropathy psoriasis and erythroderma psoriasis at present.
  2. 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;
  3. Any infectious skin disease that confuses the evaluation of the efficacy of scalp psoriasis
  4. 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.
  5. 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.
  6. Randomly enrolled (1st visit) subjects who have received PUVA treatment 4 weeks before or during the study period;
  7. Randomly enrolled (1st visit) subjects that had received ultraviolet therapy 2 weeks before or during the study period;
  8. The subjects that had received the following treatments 2 weeks before the 2nd screening or during the study period:

    1. Strong or extremely effective steroid hormone external preparations for psoriasis on the body and limbs (WHO Class III-IV);
    2. External immunomodulators (such as tacrolimus ointment, etc.)
    3. External use of vitamin D analogues (e.g. captopril preparation, tacalcitol and calcitriol);
    4. External treatment of various types of scalp psoriasis (except for shampoos or softeners that are not steroid drugs);
    5. Other treatments for psoriasis: such as traditional Chinese medicine or Chinese patent medicine, hot springs, etc.
  9. 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.
  10. Subjects who are known or suspected to be allergic to the drug components in the study;
  11. Pregnant or fertile female intend to be pregnant or lactating during the study period;
  12. In the 2nd screening visit, the serum or urine pregnancy test of fertile women is positive.
  13. The subjects who participated in other clinical trials within 4 weeks of randomization;
  14. 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
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.
활성 비교기: Capotetriol scalp solution
30ml/bottle. Two times a day for 4 weeks, topically applied to scalp psoriasis.
Capotetriol scalp solution: 30ml/bottle. Two times a day for 4 weeks, topically applied to scalp psoriasis.
위약 비교기: 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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Success rate at the end of treatment (4th week) in each group (percentage of patients with overall score of < 1)
기간: 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.

Change of success rate from baseline at 4 weeks
The clinical signs of psoriasis (erythema, infiltration, and scaly) (The Total sign score (TSS))
기간: 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).

Change of sclinical signs of psoriasis from baseline at 4 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Evaluation criteria of pruritus symptoms in the subjects
기간: Change of spruritus symptoms from baseline at 4 weeks

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.

  1. Asymptomatic: no itching;
  2. Mild: mild itching, no irritation;
  3. Moderate: markedly itchy, somewhat irritable, but no insomnia;
  4. Severe: Strong itching causes significant irritability, affects sleep, and scratches are visible.
Change of spruritus symptoms from baseline at 4 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2018년 11월 30일

기본 완료 (실제)

2019년 7월 4일

연구 완료 (실제)

2019년 11월 25일

연구 등록 날짜

최초 제출

2021년 3월 9일

QC 기준을 충족하는 최초 제출

2021년 3월 15일

처음 게시됨 (실제)

2021년 3월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 3월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 3월 15일

마지막으로 확인됨

2021년 3월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • XijingH-PF-Pso-2018/2019

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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