- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02385318
To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis
2021년 10월 29일 업데이트: Padagis LLC
The purpose of this study is to compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of actinic keratosis.
연구 개요
연구 유형
중재적
등록 (실제)
519
단계
- 3단계
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 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria
- Provide written informed consent/assent
- Healthy male or non-pregnant females, >18 years old
- Subjects must have clinical diagnosis of actinic keratosis
- Subjects must be in general good health and free from any clinically significant disease that might interfere with the study evaluations in the opinion of the investigator
- Subjects must be willing to refrain from using non-approved products on the targeted treatment area during the study period.
- Subjects should be willing to refrain from using any type of bandage or dressing on the treatment area or apply the gel to open skin wounds, infections, or exfoliative dermatitis.
- Subjects must be willing and able to comply with the requirements of the study for the duration of the study period.
- Females of childbearing potential willing to use an acceptable form of birth control
Exclusion
- Females who are pregnant, nursing, or planning a pregnancy within the study participation period
- Subjects who are immunocompromised or HIV positive or who have any immune-system disorders including auto-immune disease
- Subjects who have or had an active herpes infection within 14 days prior to the baseline visit
- Subjects who have any evidence of carcinoma or any other cancer on the face and scalp
- Presence of an incompletely healed wound within the treatment area or within 5cm of the treatment area
- Presence of any skin condition in the treatment area that may be made worse by treatment with the study medication
- Subjects who have used a tanning salon, tanning booth, sunbathing or have excessive prolonged exposure to the sun 7 days prior to Visit 1/Day 1 (baseline) or planned throughout the study
- Subjects who plan to use artificial tanners within 5cm of the selected treatment area throughout the study
- Use of NSAIDs within 7 days from Visit 1/Day 1 (Baseline) or initiation during the trial.
- Subjects who had select cosmetic or therapeutic procedures within 2cm of the selected treatment area and within 14 days of Visit 1/Day 1 (baseline) or within 10cm of the selected treatment area planned anytime during the study.
- Subjects who have had or are scheduling elective surgery within 1 month before or after the study period
- Prior use within 30 days of Visit 1/ Day 1 (baseline) or planned use during the study of immunomodulators, immunosuppressive therapies, interferon, interferon inducers, systemic corticosteroids, and cytotoxic drugs
- Subjects undergoing treatment or received treatment within 8 weeks of Visit 1/Day 1 (baseline) and within 2cm of the selected area or planned during anytime in the study of: 5-FU, imiquimod, diclofenac, photodynamic therapy used in combination with photosensitizing cream.
- Subjects who used PUVA or UVB therapy on the face or scalp within 6 months prior to Visit 1/Day 1 (baseline) or are planning to receive PUVA therapy, UVB therapy, or nonprescription UV light sources anywhere on the body during the study.
- Subjects who have taken systemic chemotherapy medications within the last 6 months prior to Visit 1/Day 1 (baseline) or planned use anytime during the study.
- Subjects who have undergone resurfacing procedures within the last 6 months prior to Visit 1/Day 1 (baseline) or planned use anytime during the study.
- Subjects who have been treated within 1 month or planning to receive treatment with systemic retinoids, hyaluronic acid, other medicated actinic keratosis therapy, or topical steroids anywhere on the head during the study.
- Subject who have a history of hypersensitivity or allergy to any ingredient in the drug product.
- Use of medicated make-up in the treatment area or significant change in the use of consumer products within 30 days of Visit 1/Day 1 (baseline) and planned use or change throughout the study.
- Start or change of dose of hormonal treatment within the past 3 months (90 days) or planned start/change throughout the study.
- Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements
- Participation in any clinical study involving an investigational product, agent, or device in the 30 days prior to Visit 1/Day 1 (baseline) or throughout the study
- Subjects who have been previously enrolled in this study
- Employee of the research center or private practice
- Subjects who in the opinion of the investigator are unlikely to be able to follow the restrictions of the protocol and complete the study
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: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
위약 비교기: 위약 제품
위약 젤
|
|
실험적: Test Product
Ingenol Mebutate
|
다른 이름들:
|
활성 비교기: Reference product
Ingenol Mebutate
|
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the Investigator
기간: Day 57
|
Day 57
|
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
2015년 2월 1일
기본 완료 (실제)
2015년 12월 1일
연구 완료 (실제)
2015년 12월 1일
연구 등록 날짜
최초 제출
2015년 1월 30일
QC 기준을 충족하는 최초 제출
2015년 3월 5일
처음 게시됨 (추정)
2015년 3월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 11월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 10월 29일
마지막으로 확인됨
2021년 10월 1일
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. .
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