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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03126539
• Other study ID #: IRB00105668
• Status: Terminated
• Phase: Phase 2
• Start date: September 15, 2017
• Est. completion date: January 18, 2019

Study information

• Verified date: June 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: January 18, 2019
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participants must be over the age of 18 years old with healthy skin;

2. Must be healthy enough to undergo skin biopsy, UV light irradiation, and other study procedures in the opinion of the investigator;

3. Must be willing to comply with the requirements of the protocol;

4. Must have the ability to understand and communicate with the investigator;

5. Participant must provide informed consent.

Exclusion Criteria:

1. Subjects who are unable to provide informed consent;

2. Subject with significant medical history or current skin diseases that the investigator feels is not safe for study participation;

3. Subjects who have been treated with systemic retinoids or steroids within the past month prior to entry to the study;

4. Subjects who have been treated with topical steroids, retinoids or other topical drugs used within 2 weeks prior to entry to the study;

5. Recently treated or current skin diseases that would affect clinical evaluation and biopsy;

6. Subjects with a known allergy to broccoli.

7. Presence or suspicion of bleeding disorder or diathesis which would complicate biopsy.

8. Subjects with a history of excessive scar or keloid formation in the past 10 years.

9. Pregnant or nursing subjects (self-reported).

10. Subjects with known allergy to anesthetics used.

11. Patients with history of investigational drug use in the 30 days prior to entry into the study.

Related Conditions & MeSH terms

• Aging

Intervention

Drug:
• Sulforaphane
Isothiocyanate sulforaphane (SF), derived from broccoli sprouts, has been known to induce an antioxidant response through the Keap1-Nrf2-antioxidant response element pathway.

Radiation:
• Narrow-band Ultraviolet B exposure
The investigators will use a Lumera ultraviolet B (UVB) light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320 nm).

Procedure:
• 4 mm skin punch biopsy
All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than four total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications and blends well with the surrounding skin.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Change Score for Mottled Hyperpigmentation	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.	Clinical Change Score for Mottled Hyperpigmentation , up to 1 week
Secondary	Gene Expression Changes as Assessed by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR)	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.	Up to 6 months
Secondary	Gene Expression Changes as Assessed by Immunohistochemistry (IHC)	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.	Up to 6 months