Clinical trial NCT03730649: Effect of Topical Sulforaphane on Skin Aging and With Ultraviolet and Visible Light Exposure
Official title: Effect of Topical Sulforaphane on Skin Aging and With Ultraviolet and Visible Light Exposure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Skin Aging
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: keratin 16 presence as determined by immunofluorescence assay
timeFrame: Up to 6 months
measure: keratin 17 presence as determined by immunofluorescence assay
timeFrame: Up to 6 months
measure: keratin 16 fold change as determined by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
timeFrame: Up to 6 months
measure: keratin 17 fold change as determined by RT-PCR
timeFrame: Up to 6 months
Secondary outcomes:
measure: keratin expression changes as determined by RT-PCR
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Cutaneous Translational Research Program, Department of Dermatology, Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Department of Dermatology, Johns Hopkins School of Medicine
name: Anna Chien
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Talalay P, Fahey JW, Healy ZR, Wehage SL, Benedict AL, Min C, Dinkova-Kostova AT. Sulforaphane mobilizes cellular defenses that protect skin against damage by UV radiation. Proc Natl Acad Sci U S A. 2007 Oct 30;104(44):17500-5. doi: 10.1073/pnas.0708710104. Epub 2007 Oct 23.
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citation: Singh K, Connors SL, Macklin EA, Smith KD, Fahey JW, Talalay P, Zimmerman AW. Sulforaphane treatment of autism spectrum disorder (ASD). Proc Natl Acad Sci U S A. 2014 Oct 28;111(43):15550-5. doi: 10.1073/pnas.1416940111. Epub 2014 Oct 13.
citation: Kerns ML, DePianto D, Dinkova-Kostova AT, Talalay P, Coulombe PA. Reprogramming of keratin biosynthesis by sulforaphane restores skin integrity in epidermolysis bullosa simplex. Proc Natl Acad Sci U S A. 2007 Sep 4;104(36):14460-5. doi: 10.1073/pnas.0706486104. Epub 2007 Aug 27.
citation: Sikdar S, Papadopoulou M, Dubois J. What do we know about sulforaphane protection against photoaging? J Cosmet Dermatol. 2016 Mar;15(1):72-7. doi: 10.1111/jocd.12176. Epub 2016 Jan 22.