Effect of Topical Sulforaphane on Skin Fragility Seen in Skin Aging and With Ultraviolet Exposure

Phase 2

Terminated

Interventions: Drug: Sulforaphane
Radiation: Narrow-band Ultraviolet B exposure
Procedure: 4 mm skin punch biopsy

Brief Summary: This study aims to compare the expression of keratins before and after application of sulforaphane (SF) to determine whether this agent alters skin fragility seen in both intrinsic and extrinsic skin aging and UV light exposure.

Detailed Description: The primary purpose of the study is to compare the expression of keratins before and after application of sulforaphane (SF) and determine whether these findings alter skin fragility seen in both intrinsic and extrinsic skin aging as well as in ultraviolet (UV) light exposure.

This investigation will be done in collaboration with researchers from the Department of Biochemistry and Molecular Biology and Bloomberg School of Public Health at Johns Hopkins University. The study population recruited by Johns Hopkins Department of Dermatology will include up to 50 individuals over the age of 18 with healthy skin. Each study participant will have four on-site study visits and will be asked to contribute photographs, undergo non invasive elasticity measurements, use topical sulforaphane for 7 days and contribute up to four biopsy specimens for laboratory study. The investigators will also evaluate any differences in keratins' expression in skin exposed to acute UV light, separately and after pretreatment with sulforaphane.

Recruitment & Eligibility

Inclusion Criteria

Participants must be over the age of 18 years old with healthy skin;
Must be healthy enough to undergo skin biopsy, UV 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.

Arm && Interventions

Group	Intervention	Description
Group B	Narrow-band Ultraviolet B exposure	Two photoprotected sites will be identified. Sulforaphane will be applied topically to a single selected site for up to 7 consecutive nights. Both site will be exposed to UV. Biopsies of both sites will be obtained prior to, and 24 hours after UV exposure.
Group A	4 mm skin punch biopsy	Sulforaphane will be applied topically to both sites for up to 7 consecutive nights. Biopsies will be obtained prior to, and immediately after this intervention, on standard photoprotected and photoexposed sites.
Group B	4 mm skin punch biopsy	Two photoprotected sites will be identified. Sulforaphane will be applied topically to a single selected site for up to 7 consecutive nights. Both site will be exposed to UV. Biopsies of both sites will be obtained prior to, and 24 hours after UV exposure.
Group A	Sulforaphane	Sulforaphane will be applied topically to both sites for up to 7 consecutive nights. Biopsies will be obtained prior to, and immediately after this intervention, on standard photoprotected and photoexposed sites.
Group B	Sulforaphane	Two photoprotected sites will be identified. Sulforaphane will be applied topically to a single selected site for up to 7 consecutive nights. Both site will be exposed to UV. Biopsies of both sites will be obtained prior to, and 24 hours after UV exposure.

Primary Outcome Measures

Name	Time	Method
Clinical Change Score for Mottled Hyperpigmentation	Clinical Change Score for Mottled Hyperpigmentation , up to 1 week	Clinical assessment of mottled hyperpigmentation pre and post Sulforaphane (SF) treatment will be done for both photoprotected and photodamaged skin treated with sulforaphane. Mottled Hyperpigmentation Score system will be applied, with scale of 0 to 4, 4= clear improvement after 1 week of SF or placebo application.

Secondary Outcome Measures

Name	Time	Method
Gene Expression Changes as Assessed by Immunohistochemistry (IHC)	Up to 6 months	We will measure the fold-change in gene expression in human skin after acute UV light exposure, separately and in combination with application of topical sulforaphane using IHC.
Gene Expression Changes as Assessed by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR)	Up to 6 months	We will measure the fold-change in gene expression in human skin after acute UV light exposure, separately and in combination with application of topical sulforaphane using RT-PCR.

Locations (1): Cutaneous Translational Research Program, Department of Dermatology, Johns Hopkins University School of Medicine
🇺🇸
Baltimore, Maryland, United States