Sulforaphane for Skin Aging

Overseen By Carly Dillen

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Johns Hopkins University

Must not be taking: Systemic retinoids, Steroids, Topical steroids, Retinoids

Disqualifiers: Skin diseases, Bleeding disorder, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 6 months

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop using systemic retinoids or steroids for at least a month and topical steroids, retinoids, or other topical drugs for at least two weeks before joining the study.

What evidence supports the effectiveness of the treatment Sulforaphane for skin aging?

Research shows that sulforaphane, found in broccoli, can help protect the skin from aging by boosting antioxidant activity and collagen production, which are important for maintaining skin health. Studies in mice and human skin models suggest that sulforaphane can reduce skin damage from UV light and improve skin appearance by activating protective pathways in the body. ^{1 2 3 4 5}

Is sulforaphane safe for human use?

Research shows that sulforaphane, found in broccoli sprout extracts, is generally safe for humans. Studies involving topical and oral applications in healthy individuals reported no significant adverse reactions or toxicities. ^{1 5 6 7 8}

How does the treatment sulforaphane differ from other treatments for skin aging?

Sulforaphane is unique because it activates the Nrf2 pathway, which helps control inflammation and oxidative stress, key factors in skin aging. Unlike many treatments, it is derived from natural sources like broccoli and works by enhancing the skin's antioxidant capacity and collagen production, offering a novel approach to combating skin aging. ^{1 2 3 6 9}

Research Team

Anna Chien

Principal Investigator

Department of Dermatology, Johns Hopkins School of Medicine

Eligibility Criteria

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.

Inclusion Criteria

I can understand and talk with my doctor.

I am healthy enough for skin biopsy, light treatment, and study procedures.

Participant must provide informed consent

Exclusion Criteria

I do not have skin conditions that could interfere with clinical tests.

Pregnant or nursing subjects (self-reported)

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply topical sulforaphane for up to 6 months, with up to 8 study visits including photography, clinical assessment, UV light irradiation, visible light treatment, skin biopsies, and non-invasive elasticity measurements

6 months

Up to 8 visits (in-person)

Follow-up

Participants are monitored for changes in keratin expression and skin response after treatment

4 weeks

Treatment Details

Interventions

• Sulforaphane
• UV or visible light

Trial Overview 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.

Participant Groups

Group I: Sulforaphane without light challenge Active Control 1 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 challenge Active Control 2 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.

Sulforaphane is already approved in United States for the following indications:

Approved in United States as Avmacol ES for:

• None approved; used in clinical trials for various conditions including chronic kidney disease and prevention of age-associated cardiac and vascular dysfunction

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Findings from Research

Aqueous extract from glucoraphanin-rich broccoli sprouts significantly inhibits the formation of advanced glycation end products (AGEs) and reduces inflammatory markers in human umbilical vein endothelial cells (HUVECs), suggesting a protective effect against vascular injury.

The extract also prevents oxidative stress by reducing reactive oxygen species (ROS) generation in HUVECs exposed to AGEs, highlighting its potential as an anti-inflammatory and antioxidant agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aqueous Extract of Glucoraphanin-Rich Broccoli Sprouts Inhibits Formation of Advanced Glycation End Products and Attenuates Inflammatory Reactions in Endothelial Cells. Sotokawauchi, A., Ishibashi, Y., Matsui, T., et al.[2020]

Sulforaphane (SF), a beneficial compound from broccoli, is absorbed more effectively from myrosinase-rich broccoli sprouts compared to glucoraphanin-rich broccoli powder, with a 74% recovery in urine from sprouts versus only 19% from the powder.

Combining broccoli sprouts with the powder improved SF absorption, suggesting that this combination could enhance the health benefits of broccoli products without causing any toxicity, as indicated by liver function tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sulforaphane absorption and excretion following ingestion of a semi-purified broccoli powder rich in glucoraphanin and broccoli sprouts in healthy men. Cramer, JM., Jeffery, EH.[2021]

A phase I clinical study involving healthy volunteers showed that broccoli sprout extracts containing glucoraphanin and sulforaphane were safe and well-tolerated, with no significant adverse effects reported during the treatment period.

The study demonstrated that the isothiocyanate sulforaphane was excreted at a much higher rate (70.6% of the dose) compared to glucosinolates, indicating effective absorption and potential for protective health benefits against diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerance, and metabolism of broccoli sprout glucosinolates and isothiocyanates: a clinical phase I study. Shapiro, TA., Fahey, JW., Dinkova-Kostova, AT., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-Term Intake of Glucoraphanin-Enriched Kale Suppresses Skin Aging via Activating Nrf2 and the TβRII/Smad Pathway in SAMP1 Mice. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Dietary supplementation with sulforaphane ameliorates skin aging through activation of the Keap1-Nrf2 pathway. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Aqueous Extract of Glucoraphanin-Rich Broccoli Sprouts Inhibits Formation of Advanced Glycation End Products and Attenuates Inflammatory Reactions in Endothelial Cells. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Photoprotective Properties of Isothiocyanate and Nitrile Glucosinolate Derivatives From Meadowfoam (Limnanthes alba) Against UVB Irradiation in Human Skin Equivalent. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Induction of the phase 2 response in mouse and human skin by sulforaphane-containing broccoli sprout extracts. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Sulforaphane absorption and excretion following ingestion of a semi-purified broccoli powder rich in glucoraphanin and broccoli sprouts in healthy men. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Keap1-nrf2 signaling: a target for cancer prevention by sulforaphane. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Safety, tolerance, and metabolism of broccoli sprout glucosinolates and isothiocyanates: a clinical phase I study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

What do we know about sulforaphane protection against photoaging? [2021]