Effect of Topical Sulforaphane on Skin Fragility Seen in Skin Aging and With Ultraviolet Exposure
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Clinical Change Score for Mottled Hyperpigmentation
研究概览
简要总结
This study aims to compare the expression of keratins before and after application of sulforaphane (SF) to determine whether this agent alters skin fragility seen in both intrinsic and extrinsic skin aging and UV light exposure.
详细描述
The primary purpose of the study is to compare the expression of keratins before and after application of sulforaphane (SF) and determine whether these findings alter skin fragility seen in both intrinsic and extrinsic skin aging as well as in ultraviolet (UV) light exposure.
This investigation will be done in collaboration with researchers from the Department of Biochemistry and Molecular Biology and Bloomberg School of Public Health at Johns Hopkins University. The study population recruited by Johns Hopkins Department of Dermatology will include up to 50 individuals over the age of 18 with healthy skin. Each study participant will have four on-site study visits and will be asked to contribute photographs, undergo non invasive elasticity measurements, use topical sulforaphane for 7 days and contribute up to four biopsy specimens for laboratory study. The investigators will also evaluate any differences in keratins' expression in skin exposed to acute UV light, separately and after pretreatment with sulforaphane.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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;
- •Must be healthy enough to undergo skin biopsy, UV 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
Group A
Sulforaphane will be applied topically to both sites for up to 7 consecutive nights. Biopsies will be obtained prior to, and immediately after this intervention, on standard photoprotected and photoexposed sites.
干预措施: Sulforaphane (Drug)
Group A
Sulforaphane will be applied topically to both sites for up to 7 consecutive nights. Biopsies will be obtained prior to, and immediately after this intervention, on standard photoprotected and photoexposed sites.
干预措施: 4 mm skin punch biopsy (Procedure)
Group B
Two photoprotected sites will be identified. Sulforaphane will be applied topically to a single selected site for up to 7 consecutive nights. Both site will be exposed to UV. Biopsies of both sites will be obtained prior to, and 24 hours after UV exposure.
干预措施: Sulforaphane (Drug)
Group B
Two photoprotected sites will be identified. Sulforaphane will be applied topically to a single selected site for up to 7 consecutive nights. Both site will be exposed to UV. Biopsies of both sites will be obtained prior to, and 24 hours after UV exposure.
干预措施: Narrow-band Ultraviolet B exposure (Radiation)
Group B
Two photoprotected sites will be identified. Sulforaphane will be applied topically to a single selected site for up to 7 consecutive nights. Both site will be exposed to UV. Biopsies of both sites will be obtained prior to, and 24 hours after UV exposure.
干预措施: 4 mm skin punch biopsy (Procedure)
结局指标
主要结局
Clinical Change Score for Mottled Hyperpigmentation
时间窗: Clinical Change Score for Mottled Hyperpigmentation , up to 1 week
Clinical assessment of mottled hyperpigmentation pre and post Sulforaphane (SF) treatment will be done for both photoprotected and photodamaged skin treated with sulforaphane. Mottled Hyperpigmentation Score system will be applied, with scale of 0 to 4, 4= clear improvement after 1 week of SF or placebo application.
次要结局
- Gene Expression Changes as Assessed by Immunohistochemistry (IHC)(Up to 6 months)
- Gene Expression Changes as Assessed by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR)(Up to 6 months)