Effect of Topical Sulforaphane on Skin Aging and With Ultraviolet and Visible Light Exposure
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- keratin 16 presence as determined by immunofluorescence assay
研究概览
简要总结
The study is to compare the expression of both keratin 16 and 17 before and after application of sulforaphane on both photoprotected and photoexposed area, and to determine whether these findings alter skin aging as well as skin response to ultraviolet (UV) and visible light exposure.
详细描述
The study is to compare the expression of both keratin 16 and 17 before and after application of sulforaphane on both photoprotected and photoexposed area, and to determine whether these findings alter skin aging as well as skin response to ultraviolet (UV) and visible light exposure.
Each study participant will have up to eight study visits. Topical sulforaphane will be applied for up to 6 months. Photography, clinical assessment, UV light irradiation, Visible light treatment, Skin biopsies, non invasive elasticity measurements such as cutometer and ballistometer, and others will be involved in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be over the age of 18 years old with healthy skin or moderate degree of photoaging/intrinsic aging;
- •Must be healthy enough to undergo skin biopsy, light irradiation, and other study procedures in the opinion of the investigator;
- •Must be willing to comply with the requirements of the protocol;
- •Must have the ability to understand and communicate with the investigator;
- •Participant must provide informed consent.
排除标准
- •Subjects who are unable to provide informed consent;
- •Subject with significant medical history or current skin diseases that the investigator feels is not safe for study participation;
- •Subjects who have been treated with systemic retinoids or steroids within the past month prior to entry to the study;
- •Subjects who have been treated with topical steroids, retinoids or other topical drugs used within 2 weeks prior to entry to the study;
- •Recently treated or current skin diseases that would affect clinical evaluation and biopsy;
- •Subjects with a known allergy to broccoli.
- •Presence or suspicion of bleeding disorder or diathesis which would complicate biopsy.
- •Subjects with a history of excessive scar or keloid formation in the past 10 years.
- •Pregnant or nursing subjects (self-reported).
- •Subjects with known allergy to anesthetics used.
- •Patients with history of investigational drug use in the 30 days prior to entry into the study.
研究组 & 干预措施
Sulforaphane without light challenge
Participants with moderate photodamage and moderate intrinsic skin aging will apply sulforaphane (broccoli sprout extract) in jojoba oil nightly (without any UV or visible light irradiation) for up to 6 months and have up to 9 biopsies taken just before treatment and occurring at regular intervals during the study
干预措施: Sulforaphane (broccoli sprout extract) (Drug)
Sulforaphane with light challenge
Participants will have 2 test areas irradiated with up to 5 UV or visible light treatments and biopsies taken before and within 7 days after UV or visible light irradiation; one of the UV/visible light treated areas will be pre-treated with sulforaphane (broccoli sprout extract) for up to 28 consecutive nights and the other UV/visible light treated areas will be pre-treated with jojoba oil.
干预措施: Sulforaphane (broccoli sprout extract) (Drug)
Sulforaphane with light challenge
Participants will have 2 test areas irradiated with up to 5 UV or visible light treatments and biopsies taken before and within 7 days after UV or visible light irradiation; one of the UV/visible light treated areas will be pre-treated with sulforaphane (broccoli sprout extract) for up to 28 consecutive nights and the other UV/visible light treated areas will be pre-treated with jojoba oil.
干预措施: UV or visible light (Radiation)
结局指标
主要结局
keratin 16 presence as determined by immunofluorescence assay
时间窗: Up to 6 months
The investigators will detect the presence of keratin 16 in the basal layer of the epidermis in both photoprotected and photodamaged skin treated with sulforaphane (SF), by immunofluorescence assay, to determine whether SF can improve skin fragility and other features seen in these conditions
keratin 16 fold change as determined by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
时间窗: Up to 6 months
The investigators will detect the fold change of keratin 16 in the basal layer of the epidermis in both photoprotected and photodamaged skin treated with SF, by RT-PCR, to determine whether SF can improve skin fragility and other features seen in these conditions
keratin 17 presence as determined by immunofluorescence assay
时间窗: Up to 6 months
The investigators will detect the presence of keratin 17 in the basal layer of the epidermis in both photoprotected and photodamaged skin treated with SF, by immunofluorescence assay, to determine whether SF can improve skin fragility and other features seen in these conditions
keratin 17 fold change as determined by RT-PCR
时间窗: Up to 6 months
The investigators will detect the fold change of keratin 17 in the basal layer of the epidermis in both photoprotected and photodamaged skin treated with sulforaphane (SF), by RT-PCR, to determine whether SF can improve skin fragility and other features seen in these conditions
次要结局
- keratin expression changes as determined by RT-PCR(Up to 6 months)