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

Early Phase 1Active Not RecruitingNCT03730649

Johns Hopkins University12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Skin Aging

Interventions

Sulforaphane (broccoli sprout extract)DRUG

Participants will topically apply Sulforaphane for a period of time

UV or visible lightRADIATION

Participants will have 2 test areas irradiated with up to 5 UV or visible light treatments

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Cutaneous Translational Research Program, Department of Dermatology, Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Up to 6 months

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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