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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03730649
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : June 9, 2023
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Skin Aging Drug: Sulforaphane (broccoli sprout extract) Radiation: UV or visible light Early Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Topical Sulforaphane on Skin Aging and With Ultraviolet and Visible Light Exposure
Actual Study Start Date : October 9, 2019
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Sulforaphane without light challenge
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
 Drug: Sulforaphane (broccoli sprout extract)
Participants will topically apply Sulforaphane for a period of time
Active Comparator: Sulforaphane with light challenge
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.
 Drug: Sulforaphane (broccoli sprout extract)
Participants will topically apply Sulforaphane for a period of time

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730649


Contacts
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Contact: Ruizhi Wang 410-502-7546 rwang53@jhmi.edu
Contact: Carly Dillen 410-502-7546 cpage9@jhmi.edu

Locations
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United States, Maryland
Cutaneous Translational Research Program, Department of Dermatology, Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21287
Contact: Ruizhi Wang    410-502-7546    Rwang@jhmi.edu   
Contact: Carly Dillen    4105027546    cpage9@jhmi.edu   
Principal Investigator: Anna L Chien, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Anna Chien Department of Dermatology, Johns Hopkins School of Medicine
More Information
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Publications:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03730649    
Other Study ID Numbers: IRB00184806
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: June 9, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sulforaphane
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents