- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01098721
A Safety/Efficacy Study of a Non-steroid, Topical Cream Treatment of Psoriasis Over 12-weeks (134993)
A Double-blinded, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Topically Applied 1.0% WBI-1001 Cream for 12 Weeks, in the Treatment of Mild to Moderate Plaque Psoriasis.
연구 개요
상세 설명
A double-blinded, placebo-controlled study. Following screening, eligible patients will be randomized on Day 0 into one of two treatment groups in a 1:2 ratio:
Group 1: placebo (vehicle) cream, twice daily (BID). Group 2: 1.0% WBI-1001 cream, BID. Patients will be randomized to treat all treatable lesion areas except for the face, scalp, groin and genital areas, and will be instructed to apply the cream twice daily for 84 days, at the same time each day, once in the morning and once in the evening.
During the study patients will visit the study centre for assessment of efficacy, safety and tolerability at 0, 14, 28, 56 and 84 days after initiation, and patients will be phoned at Day 112 for a follow-up safety assessment.
Patients that withdraw from the study before Day 56 due to reasons other than adverse events will be replaced as necessary to ensure that there are at least 16 patients from the placebo and 32 from the active cream treated groups remaining in the study at Day 56.
연구 유형
등록 (실제)
단계
- 2 단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- A clinical diagnosis of stable plaque psoriasis for at least 6 months representing a maximum of 10% of BSA with a minimum of 1% BSA excluding the face, groin ,scalp and genital regions and with a minimum of one target plaque that is at least 2 x 2 cm in size at Day 0.
- PGA of 2 to 4 at Day 0.
- In good general health and free of any disease state or physical condition that might impair the evaluation of plaque psoriasis.
- Women of child bearing potential (WOCBP) must have a negative serum beta-human chorionic gonadotrophin (b-hCG) pregnancy test before randomization. WOBCP who are not abstinent from sex with male partners may be entered into the study if they are willing to continue to use adequate contraceptive precautions for the duration of the study. Male patients with female sexual partners who are able to become pregnant must ensure that an acceptable method of birth control is used while they are in the study. Women who are lactating will not be eligible for the study.
- Willing and able to comply with the protocol and likely to attend all study visits.
- Provide written, informed consent prior to the initiation of any study-related procedures.
Exclusion Criteria:
- Spontaneously improving or rapidly deteriorating plaque psoriasis.
- Any other skin diseases that might interfere with the clinical assessment of plaque psoriasis and/or put the patient at risk.
- Pustular, erythrodermic or other non-plaque forms pf psoriasis.
- Guttate psoriasis as the dominant form of psoriasis.
- Other concomitant, serious illness or medical condition (eg., human immunodeficiency virus, renal insufficiency, clinically significant abnormal laboratory values) that could put the patient at risk during the study.
- History of neurological/psychiatric disorders, including psychotic disorders or dementia, or any other reason that would interfere with the patient's participation in the trial.
- Systemic immunomodulatory therapy known to affect psoriasis and decreases immune cell populations (eg., alefacept) within 24 weeks of the baseline visit.
- Systemic immunomodulatory therapy known to affect psoriasis and that does not typically decrease immune cell populations (eg., etanercept) within 12 weeks prior to the baseline visit.
- Any phototherapy (including laser for the treatment of psoriasis), photo-chemotherapy,or systemic psoriasis therapy (such as systemic corticosteroids, methotrexate, retinoids or cyclosporine) within 4 weeks prior to the baseline visit.
- Prolonged exposure to artificial or natural sources of ultraviolet radiation within 4 weeks prior to the baseline visit or intention to have such exposure during the study, thought by the investigator likely to modify the patient's psoriasis.
- Topical anti-psoriatic therapy (including topical retinoids and vitamin D analogs) on the areas to be treated within 2 weeks prior to the baseline visit.
- Alcohol abuse during the last 2 years as defined by the consumption of >14 standard drinks of alcohol per week.
- Use of lithium within 2 weeks prior to the screening visit.
- Use of beta blockers (eg., propranolol) within 2 weeks prior to the screening visit unless on a stable dose for >3 months.
- Known or suspected hypersensitivity to any of the constituents of the investigational product.
- Treatment with an investigational drug within 1 month of Day 0 or current participation in another clinical trial.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
위약 비교기: Group 1
A placebo cream applied topically twice daily (BID)by each of 20 patients, once in the morning and once in the evening for 12 weeks.
|
Comparison of two doses (0% and 1.0%) of the the WBI-1001 cream applied topically, twice daily for 12 weeks.
|
활성 비교기: Group 2
A 1.0% WBI-1001 cream applied topically twice daily (BID) by each of 40 patients, once in the morning and once in the evening for 12 weeks.
|
Comparison of two doses (0% and 1.0%) of the the WBI-1001 cream applied topically, twice daily for 12 weeks.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change from baseline (Day 0) in PGA in patients randomized to placebo as compared to patients randomized to 1.0% WBI-1001.
기간: 84 days
|
The primary indication of efficacy will be demonstrated by improvement in the Physician's Global Assessment (PGA) in patients treated with the active (1.0%
WBI-1001) cream as compared with those treated with the placebo cream.
|
84 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in PASI score from baseline (Day 0) to Day 84 for patients in Group 1 compared with those in Group 2.
기간: 84 days
|
Change in the Psoriasis Area and Severity Index (PASI) score from the baseline (Day 0) at Day 84 in patients randomized to the placebo compared with those randomized to the 1.0% WBI-1001 cream treatment.
|
84 days
|
Blood and urine analyses and vital signs assessments of patients from Day 0 to Day 84, and the follow-up at Day 112.
기간: 84 days plus 112 day follow-up.
|
Comparative assessment of the laboratory analyses and vital signs of Group 1 and Group 2 patients from Day 0 to Day 84, and the follow-up at Day 112.
|
84 days plus 112 day follow-up.
|
Change from baseline in BSA at Day 84 in patients randomized to placebo compared with those randomized to 1.0% WBI-1001 cream treatment.
기간: 84 days
|
Change in the BSA of involved skin (except for the face, scalp, groin and genital areas) from that at baseline (Day 0) to that at Day 84 when comparing patients in Group 1 with those in Group 2.
|
84 days
|
Change from baseline (Day 0) in mean target lesion score at Day 84 in patients in Group 1 compared with those in Group 2.
기간: 84 days
|
84 days
|
|
Change from baseline (Day 0)in target lesion induration at Day 84 in patients in Group 1 compared with those in Group 2.
기간: 84 days
|
84 days
|
|
Change from baseline (Day 0) in target lesion scaling at Day 84 in patients in Group 1 compared with those in Group 2.
기간: 84 days
|
84 days
|
|
Change from baseline (Day 0)in target lesion erythema at Day 84 in patients from Group 1 compared with those from Group 2.
기간: 84 days
|
84 days
|
|
Type, frequency, severity and relationship of adverse events in patients from Group 1 compared with those from Group 2.
기간: 84 days + follow-up at 112 days
|
84 days + follow-up at 112 days
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Robert Bissonnette, MD, MSc, Innovaderm Research Inc.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
WBI-1001에 대한 임상 시험
-
Cancer Institute and Hospital, Chinese Academy...완전한
-
Guangdong Association of Clinical TrialsGuangdong Provincial People's Hospital완전한
-
K36 Therapeutics, Inc.모병
-
HemaQuest Pharmaceuticals Inc.완전한겸상 적혈구 질환 | 겸상 적혈구 빈혈 | 낫적혈구 장애 | 헤모글로빈 S병 | 헤모글로빈 S로 인한 겸상 질병미국, 레바논, 캐나다, 이집트, 자메이카
-
NSABP Foundation IncNational Cancer Institute (NCI); Radiation Therapy Oncology Group모집하지 않고 적극적으로2기 유방암 | IB기 유방암미국, 캐나다, 이스라엘, 푸에르토 리코, 대한민국, 일본, 아일랜드