Effect of Topical Sulforaphane on Skin Aging and With Ultraviolet and Visible Light Exposure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Topical Sulforaphane on Skin Aging and With Ultraviolet and Visible Light Exposure

Conditions
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Skin Aging

Intervention / Treatment
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* Drug: Sulforaphane (broccoli sprout extract)
* Radiation: UV or visible light


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sulforaphane without light challenge<br>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 | Drug: Sulforaphane (broccoli sprout extract)<br>* Participants will topically apply Sulforaphane for a period of time<br>|
| Active Comparator: Sulforaphane with light challenge<br>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. | Drug: Sulforaphane (broccoli sprout extract)<br>* Participants will topically apply Sulforaphane for a period of time<br>Radiation: UV or visible light<br>* Participants will have 2 test areas irradiated with up to 5 UV or visible light treatments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| keratin 16 presence as determined by immunofluorescence assay | 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 | Up to 6 months | 
| keratin 17 presence as determined by immunofluorescence assay | 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 | Up to 6 months | 
| keratin 16 fold change as determined by Reverse Transcription Polymerase Chain Reaction (RT-PCR) | 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 | Up to 6 months | 
| keratin 17 fold change as determined by RT-PCR | 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 | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| keratin expression changes as determined by RT-PCR | The investigators will test the fold change of keratin expression in human skin after acute UV and visible light light exposure, separately and in combination with application of topical sulforaphane by RT-PCR. | Up to 6 months |