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

Johns Hopkins University

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Skin Aging

Treatments: Radiation: UV or visible light; Drug: Sulforaphane (broccoli sprout extract)

Study type: Interventional

Funder types: Other

Identifiers

NCT03730649

IRB00184806

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Sulforaphane without light challenge

Active Comparator group

Description:

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

Treatment:

Drug: Sulforaphane (broccoli sprout extract)

Sulforaphane with light challenge

Active Comparator group

Description:

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.

Treatment:

Drug: Sulforaphane (broccoli sprout extract)

Radiation: UV or visible light