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

Skin Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03730649
• Other study ID #: IRB00184806
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 9, 2019
• Est. completion date: April 2025

Study information

• Verified date: June 2023
• Source: Johns Hopkins University
• Contact: Ruizhi Wang
• Phone: 410-502-7546
• Email: rwang53[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Skin Aging

Intervention

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

Locations

Country	Name	City	State
United States	Cutaneous Translational Research Program, Department of Dermatology, Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (7)

Dinkova-Kostova AT, Talalay P, Sharkey J, Zhang Y, Holtzclaw WD, Wang XJ, David E, Schiavoni KH, Finlayson S, Mierke DF, Honda T. An exceptionally potent inducer of cytoprotective enzymes: elucidation of the structural features that determine inducer potency and reactivity with Keap1. J Biol Chem. 2010 Oct 29;285(44):33747-55. doi: 10.1074/jbc.M110.163485. Epub 2010 Aug 26. — View Citation

Egner PA, Chen JG, Wang JB, Wu Y, Sun Y, Lu JH, Zhu J, Zhang YH, Chen YS, Friesen MD, Jacobson LP, Munoz A, Ng D, Qian GS, Zhu YR, Chen TY, Botting NP, Zhang Q, Fahey JW, Talalay P, Groopman JD, Kensler TW. Bioavailability of Sulforaphane from two broccoli sprout beverages: results of a short-term, cross-over clinical trial in Qidong, China. Cancer Prev Res (Phila). 2011 Mar;4(3):384-95. doi: 10.1158/1940-6207.CAPR-10-0296. — View 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. — View Citation

Shapiro TA, Fahey JW, Dinkova-Kostova AT, Holtzclaw WD, Stephenson KK, Wade KL, Ye L, Talalay P. Safety, tolerance, and metabolism of broccoli sprout glucosinolates and isothiocyanates: a clinical phase I study. Nutr Cancer. 2006;55(1):53-62. doi: 10.1207/s15327914nc5501_7. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 6 months
Primary	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	Up to 6 months
Primary	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	Up to 6 months
Primary	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	Up to 6 months
Secondary	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.	Up to 6 months