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NCT Number: NCT03730649

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

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

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sulforaphane (broccoli sprout extract)

Drug

Participants will topically apply Sulforaphane for a period of time

UV or visible light

Radiation

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

Primary outcomes

  1. keratin 16 presence as determined by immunofluorescence assay

    Time frame: Up 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

  2. keratin 17 presence as determined by immunofluorescence assay

    Time frame: Up 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

  3. keratin 16 fold change as determined by Reverse Transcription Polymerase Chain Reaction (RT-PCR)

    Time frame: 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

  4. keratin 17 fold change as determined by RT-PCR

    Time frame: Up 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 outcomes

  1. keratin expression changes as determined by RT-PCR

    Time frame: Up 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Nov 5, 2018
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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