- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07695753
A Study to Evaluate the Ability of Sunscreen Products to Modulate the Effects of Deep UVA +/- HEV Blue Light Induced Pigmentation and Biomarkers of Cutaneous Oxidative Stress
2026년 7월 8일 업데이트: Kenvue Brands LLC
A Single Center, Controlled Study to Evaluate the Ability of Sunscreen Products to Modulate the Effects of Deep UVA +/- HEV Blue Light Induced Pigmentation and Biomarkers of Cutaneous Oxidative Stress
To assess the level of sub pigmentation following an acute exposure to a Deep Ultraviolet A and high energy Blue Light wavelengths (380-420 nm).
This study will compare the unprotected control with test products in Condition #1 and Condition #2 to assess pigmentation as well as cutaneous oxidative stress and inflammation biomarkers that occur with exposure to the same light regimen.
연구 개요
연구 유형
중재적
등록 (실제)
22
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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New Jersey
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Union, New Jersey, 미국, 07083
- SGS North America, Inc. - Union Research Center
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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
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- Fitzpatrick Skin Type III or IV targeting to complete at least 5 subjects in each skin type.
- Has ITA (calculated per the method defined in ISO24442:2022) of 10.00° to 41.00° for each test site (average value from subsites 1 and 7 per site) , with no variation in ITA° greater than 5° between test sites (having uniform skin color over the whole test area).
- Agrees to receive artificial sunlight (UV) exposure on the back.
- Agrees to refrain from sun exposure on the back, use of tanning beds, and self-tanning lotions, creams, or sprays until the completion of the study.
- Generally in good health based on medical history reported by the subject.
- Able to read, write, speak, and understand English.
- Has signed the Consent for Photograph Release and ICD including Health Insurance Portability and Accountability Act (HIPAA) disclosure.
- Intends to complete the study and is willing and able to follow all study instructions.
Exclusion Criteria:
- Has known allergies or adverse reactions to latex, common topical skincare products, UV light, or ingredients in the ISMs.
- Has a history of abnormal responses to sunlight or UV radiation.
- Has been instructed by a physician, pharmacist, or health professional to avoid sunlight because of a medical condition and/or because of drug contraindications.
- Has a history of photosensitivity (a reaction to sunlight) disorders (including solar urticaria [hives], phototoxicity, photo-allergy, polymorphous light eruptions).
- Is regularly taking a medication with photosensitizing potential, such as high blood pressure medication, acne medications (e.g., Accutane), certain psychiatric medications (e.g., Thorazine, tricyclic anti-depressants), certain antibiotics (e.g., Cipro, tetracycline), antihistamines (e.g., Benadryl), Levulan, or Psoralen.
- Is regularly taking other medication that could affect the results of the study (e.g., corticosteroids, steroidal or nonsteroidal anti-inflammatory drugs [NSAIDs], antihypertensive drugs, steroid inhalers, drugs that induce skin coloring, etc.). Low dose aspirin (≤81mg per day) is acceptable.
- Has used a tanning bed/lamp, has had extended sun exposure of the test area (the lower back), or has participated in a UV exposure study within 4 weeks before Visit 1.
- Has a concurrent illness, a medical history of a disease/condition, or a pre-existing/dormant dermatologic condition (e.g., psoriasis, rashes, eczema, seborrheic, severe excoriations, skin infection [fungal, bacterial, or viral], etc.) that could interfere with the outcome of the study or increase health risk to the subject, as determined by the PI or designee.
- Via visible light and Wood's lamp evaluation: presence of sunburn, suntan, scars, tattoos, active dermal lesions, nevi, blemishes, moles, excessive tan spots from prior sunscreen testing, excessive hair, or uneven skin tone on the test area (back) that might interfere with the study.
- Has a history of immunosuppression/immune deficiency disorders (including HIV infection, AIDS, multiple sclerosis, Crohn's disease, rheumatoid arthritis), organ transplant (heart, kidney, etc.), and/or undergoing radiation or chemotherapy as determined by study documentation.
- Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication.
Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including:
- Non-steroidal anti-inflammatory drugs within 5 days before Visit 1.*
- Antihistamines within 14 days before Visit 1.*
- Antibiotics within 16 days prior to Visit 1.*
- Immunosuppressive drugs or steroidal drugs within 2 months before Visit 1.*
- Systemic or topical medication that is known to alter responses to UV radiation.* * If an individual is taking one of these medication types, the individual is not considered eligible at screening. However, if a subject begins using one of these medications during the study, the PI should be consulted to consider the impact of the specific medication on subject safety and/or the study results.
- Has a personal or family history of skin cancer.
- Has skeletal protrusions and/or extreme areas of curvature in the test area.
- Is self-reported to be pregnant, lactating, or planning to become pregnant during the study or within 30 days of study completion.
- Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study .
- Has shaved, waxed, and/or used any hair removal method on the test area (back) within 2 weeks before visit 1.
- Has applied any leave on product(s) on the test area within 24 hours before Visit 1.
- Is simultaneously participating in any other clinical study or has participated in any product-use study within 30 days prior to Visit 1.
- Has started a long-term medication within the last 2 months.
- Has started hormone replacement therapies (HRT) or hormones for birth control or menopause less than 3 months before study enrollment or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
- Is an employee/contractor of the PI, Study Site, or Sponsor or immediate family member of the PI, Study Site Personnel, or Sponsor
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: All Subjects (Condition #1)
A trained designee will mark four test sites on the subject's back.
Each test site will contain seven subsites: one on-irradiated control (subsite 1) and six subsites (subsites 2-7) designated for increasing light-radiation doses.
At Visit 1, the IPs will be applied under Condition #1.
Test site 1 will remain unprotected.
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At Visit 1, the IPs will be applied under Condition #1.
After 24 hours, the test site will be cleaned, the same IP will be reapplied directly to the test site and allowed to air dry before irradiation.
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실험적: All Subjects (Condition #2)
At Visit 2, Sunscreen A will be applied to test site 4 under Condition #2.
Test site 1 will remain unprotected.
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At Visit 2, Sunscreen A will be applied to site 4 under Condition #2.
The site will air dry before irradiation.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical evaluation of pigmentation
기간: Visit 2/Day 2 (15 Minutes Post-Irradiation timepoint only) and Visit 3 (18-22 Hours Post-Irradiation).
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Percent mean change from baseline analysis and comparison between test sites and between subsites .
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Visit 2/Day 2 (15 Minutes Post-Irradiation timepoint only) and Visit 3 (18-22 Hours Post-Irradiation).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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SkinColorCatch measurements
기간: Visit 1/Day1, Visit 2/Day2 (Pre- irradiation and 15 Minutes Post-Irradiation), and Visit 3/Day 3 (18-22 Hours Post-Irradiation).
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Percent mean change from baseline analysis and comparison between test sites and between subsites
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Visit 1/Day1, Visit 2/Day2 (Pre- irradiation and 15 Minutes Post-Irradiation), and Visit 3/Day 3 (18-22 Hours Post-Irradiation).
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Imaging of test sites
기간: Visit 2/Day 2 (15 Minutes Post-Irradiation timepoint only) and Visit 3/Day 3(18-22 Hours Post-Irradiation).
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Percent mean change from baseline analysis and comparison between test sites and between subsites
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Visit 2/Day 2 (15 Minutes Post-Irradiation timepoint only) and Visit 3/Day 3(18-22 Hours Post-Irradiation).
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Tape stripping for protein analyses
기간: Visit 3/Day 3 (18-22 Hours Post-Irradiation)
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Percent mean change from baseline analysis and comparison between test sites and between subsites.
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Visit 3/Day 3 (18-22 Hours Post-Irradiation)
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Skin swabbing for cutaneous biomarkers
기간: Visit 3/Day 3 (18-22 Hours Post-Irradiation
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Percent mean change from baseline analysis and comparison between test sites and between subsites.
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Visit 3/Day 3 (18-22 Hours Post-Irradiation
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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)
2025년 10월 27일
기본 완료 (실제)
2025년 12월 6일
연구 완료 (실제)
2025년 12월 6일
연구 등록 날짜
최초 제출
2026년 6월 11일
QC 기준을 충족하는 최초 제출
2026년 7월 8일
처음 게시됨 (실제)
2026년 7월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 8일
마지막으로 확인됨
2026년 7월 6일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CS2025SK100256
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .
산화 스트레스에 대한 임상 시험
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Goethe UniversityLudwig-Maximilians - University of Munich완전한
Sunscreen application #1에 대한 임상 시험
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Denver Health and Hospital Authority완전한
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University Hospital of North NorwayThe Research Council of Norway; European Commission; Oslo University College완전한
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London Vision ClinicOptana GmbH모집하지 않고 적극적으로
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St. George's Hospital, London아직 모집하지 않음
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mHealth Systems Inc.Boston Children's Hospital; University of North Carolina, Charlotte모병
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Johns Hopkins Bloomberg School of Public HealthNational Heart, Lung, and Blood Institute (NHLBI); Oakland University모병정상 및 비상 상황에서 식량 불안 인구의 건강 식품 접근성 개선미국