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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests sulforaphane, an extract from broccoli sprouts, to determine its effects on skin aging and the skin's response to light. Researchers aim to discover whether sulforaphane alters certain proteins in the skin before and after exposure to ultraviolet (UV) and visible light. Participants will apply sulforaphane either without light exposure or with a light challenge to assess its impact on skin health. This trial may suit individuals with moderate skin aging who are willing to undergo skin biopsies and adhere to the study's guidelines. As an Early Phase 1 trial, this research seeks to understand how sulforaphane functions in people, offering participants a chance to contribute to groundbreaking skin health research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that sulforaphane, a substance in broccoli, is generally safe. It has been used in various forms, such as extracts, for up to six months without major issues. Some studies tested broccoli seed extract and found it non-toxic even with repeated use, indicating that sulforaphane is usually well-tolerated.

For those considering this treatment with light exposure, current evidence also supports sulforaphane's safety. Although it might be used with some UV or visible light in this trial, past studies have not shown any significant side effects from the compound itself. Overall, while sulforaphane remains under study, existing research supports its safe use in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for skin aging, which often involve topical retinoids or hyaluronic acid fillers, sulforaphane offers a plant-based approach derived from broccoli sprout extract. Researchers are excited about sulforaphane because it targets skin aging at a cellular level by potentially activating protective enzymes, which might reduce oxidative damage and improve skin resilience. The study also explores two unique application methods: one without light exposure and another combined with UV or visible light, aiming to understand how sulforaphane interacts with different environmental factors to enhance skin health.

What evidence suggests that sulforaphane might be an effective treatment for skin aging?

Research has shown that sulforaphane, a substance in broccoli sprouts, may help protect and improve skin health. Studies have found that sulforaphane can reduce damage from sunlight, which often leads to skin aging. In this trial, participants will be divided into two groups: one group will apply sulforaphane without any UV or visible light irradiation, while the other group will receive sulforaphane with light challenge. Previous observations indicate that sulforaphane decreases skin inflammation caused by UVB rays, suggesting it could act as a protective agent. Additionally, sulforaphane has anti-inflammatory effects, which might help reduce signs of skin aging. These findings suggest that sulforaphane could be effective in fighting skin damage and aging, especially when the skin is exposed to light. ^{6 7 8 9 10}

Who Is on the Research Team?

Anna Chien

Principal Investigator

Department of Dermatology, Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03730649

Effect of Topical Sulforaphane on Skin Aging and With ... 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, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2077285/

Sulforaphane mobilizes cellular defenses that protect skin ... The a* measurements, confirmed by visual inspection, provided evidence that, although SF treatment inhibited UV erythema in most observations ( ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03126539

Effect of Topical Sulforaphane on Skin Fragility Seen in ... This study aims to compare the expression of keratins before and after application of sulforaphane (SF) to determine whether this agent alters skin ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955286309000874

Sulforaphane suppresses ultraviolet B-induced ... These results suggest that SF has a potential use as a compound for protection against UVB-induced skin inflammation. Introduction. Cruciferous vegetables (e.g. ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3280724/

Dietary glucoraphanin-rich broccoli sprout extracts protect ... Sulforaphane was subsequently shown to protect against carcinogenesis in more than 10 different animal models involving various carcinogens and target organs.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6804255/

Broccoli or Sulforaphane: Is It the Source or Dose That ... There is robust epidemiological evidence for the beneficial effects of broccoli consumption on health, many of them clearly mediated by the isothiocyanate ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05745636

NCT05745636 | Broccoli Seed Extract and Skin Health The primary objective of this study is to examine the influence of 4-weeks ingestion of TrueBroc®, (broccoli seed extract, BSE) with mustard seed powder ...

8. webmd.com webmd.com/vitamins/ai/ingredientmono-1070/sulforaphane

Sulforaphane - Uses, Side Effects, and More It is possibly safe when used as medicine. Sulforaphane and sulforaphane-rich broccoli extract products have been used safely for up to 6 months. It's usually ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0273230015300441

Broccoli seed extract: Genotoxicity and subchronic toxicity ... A broccoli seed extract (BSE) containing 13% glucoraphanin was tested for genotoxicity and repeated dose toxicity.

10. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/Sulforaphane-Cognitive-Vitality-For-Researchers.pdf

Sulforaphane Aging and related health concerns: Evidence from multiple meta-analyses suggest that eating cruciferous vegetables may prevent cancer, but there is little ...