What side effects are associated with this type of intervention?

Common treatments for skin aging, such as topical antioxidants (e.g., vitamin C, vitamin E, coenzyme Q10) and Nrf2 activators, can cause side effects like skin irritation, redness, and allergic reactions. While generally well-tolerated, these treatments may lead to mild dermatitis in some individuals. Consulting with a healthcare provider is essential to tailor the treatment to individual needs and to monitor for any adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for skin aging that focus on antioxidant properties and protection against UV damage. Notable examples include topical retinoids like tretinoin, which promote collagen production and skin renewal, and antioxidants such as vitamin C serums that neutralize free radicals. Additionally, products containing hyaluronic acid are approved for their hydrating and plumping effects on the skin. While sulforaphane specifically targets the Nrf2 pathway to reduce oxidative stress, similar antioxidant-based treatments are widely recognized for their efficacy in mitigating signs of skin aging.

What other types of research exist?

Promising alternatives to Sulforaphane for skin aging include photodynamic therapy (PDT) with agents like aminolevulinic acid (ALA) and methyl aminolevulinate (MAL), which have shown efficacy in treating actinic keratosis and potentially improving skin appearance. Additionally, compounds like hypericin used in photodynamic therapy have demonstrated anti-aging effects through their photodynamic activity. These treatments offer novel approaches by leveraging light-activated compounds to induce beneficial skin changes.

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Phytochemical

Sulforaphane for Skin Aging

Q: What is the mechanism of action of this treatment?

The most common treatments for skin aging often involve antioxidants and agents that activate the Nrf2 pathway. Antioxidants, such as sulforaphane, help neutralize free radicals, which are unstable molecules that can damage skin cells and accelerate aging. Activation of the Nrf2 pathway enhances the skin's defense mechanisms by upregulating the expression of various protective genes, including those involved in antioxidant production and detoxification processes. These mechanisms are crucial for skin aging patients as they help reduce oxidative stress, improve skin resilience, and potentially reverse some signs of aging, leading to healthier and more youthful-looking skin.

Phase < 1

Recruiting

Led By Anna Chien

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be over the age of 18 years old with healthy skin or moderate degree of photoaging/intrinsic aging

Be older than 18 years old

Must not have

Subjects with a history of excessive scar or keloid formation in the past 10 years

Presence or suspicion of bleeding disorder or diathesis which would complicate biopsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Summary

This trial involves applying sulforaphane, a compound from vegetables, to the skin of participants. The study aims to see if sulforaphane can change how the skin ages and responds to light by looking at specific skin proteins. Participants will have both sun-exposed and non-exposed skin areas treated and monitored over time.

Who is the study for?

This trial is for adults over 18 with healthy skin or moderate photoaging, who can undergo a skin biopsy and light exposure. They must understand the study and agree to follow its rules. People with recent drug trials, broccoli allergies, steroid or retinoid treatments, bleeding disorders, excessive scarring tendencies, pregnancy/nursing status, anesthesia allergies or significant medical issues are excluded.

What is being tested?

The trial tests how sulforaphane (a compound from broccoli) affects skin aging when applied before exposing the skin to UV and visible light. Researchers will look at changes in specific proteins (keratin 16 & 17) in protected vs. exposed skin areas to assess any impact on aging.

What are the potential side effects?

Potential side effects of topical sulforaphane may include local irritation or allergic reactions where it's applied. The procedure itself might cause discomfort during biopsies and temporary redness or sensitivity due to light exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 and have healthy skin or some signs of aging.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had excessive scarring or keloids in the last 10 years.

Select...

I might have a bleeding disorder that could make a biopsy risky.

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I have not taken systemic retinoids or steroids in the last month.

Select...

I am unable to understand and give consent for my treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

keratin 16 fold change as determined by Reverse Transcription Polymerase Chain Reaction (RT-PCR)

keratin 16 presence as determined by immunofluorescence assay

keratin 17 fold change as determined by RT-PCR

+1 more

Secondary study objectives

keratin expression changes as determined by RT-PCR

Trial Design

2Treatment groups

Active Control

Group I: Sulforaphane without light challengeActive Control1 Intervention

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

Group II: Sulforaphane with light challengeActive Control2 Interventions

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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for skin aging often involve antioxidants and agents that activate the Nrf2 pathway. Antioxidants, such as sulforaphane, help neutralize free radicals, which are unstable molecules that can damage skin cells and accelerate aging. Activation of the Nrf2 pathway enhances the skin's defense mechanisms by upregulating the expression of various protective genes, including those involved in antioxidant production and detoxification processes. These mechanisms are crucial for skin aging patients as they help reduce oxidative stress, improve skin resilience, and potentially reverse some signs of aging, leading to healthier and more youthful-looking skin.