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

Early Phase 1
Active, not recruiting
Conditions
Skin Aging
Interventions
Radiation: UV or visible light
Registration Number
NCT03730649
Lead Sponsor
Johns Hopkins University
Brief Summary

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.

Detailed 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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
120
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sulforaphane with light challengeUV or visible lightParticipants 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 without light challengeSulforaphane (broccoli sprout extract)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
Sulforaphane with light challengeSulforaphane (broccoli sprout extract)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.
Primary Outcome Measures
NameTimeMethod
keratin 16 presence as determined by immunofluorescence assayUp to 6 months

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

keratin 16 fold change as determined by Reverse Transcription Polymerase Chain Reaction (RT-PCR)Up to 6 months

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

keratin 17 presence as determined by immunofluorescence assayUp to 6 months

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

keratin 17 fold change as determined by RT-PCRUp to 6 months

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

Secondary Outcome Measures
NameTimeMethod
keratin expression changes as determined by RT-PCRUp to 6 months

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.

Trial Locations

Locations (1)

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

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Baltimore, Maryland, United States

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