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

NCT03126539 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: IRB00105668
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

aging; ultraviolet exposure; skin fragility; sulforaphane

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Gene Expression Changes as Assessed by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR)

  Up to 6 months

• Gene Expression Changes as Assessed by Immunohistochemistry (IHC)

  Up to 6 months

Study Arms (2)

Group A

EXPERIMENTAL

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.

Drug: Sulforaphane; Procedure: 4 mm skin punch biopsy

Group B

EXPERIMENTAL

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.

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

Interventions

Sulforaphane DRUG

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

Also known as: Broccoli sprout extract; isothiocyanate sulforaphane

Group A; Group B

Narrow-band Ultraviolet B exposure RADIATION

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).

Also known as: UVB, UV

Group B

4 mm skin punch biopsy PROCEDURE

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.

Also known as: biopsy

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Cutaneous Translational Research Program, Department of Dermatology, Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Interventions

sulforaphane; Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Anna Chien
• Organization: Johns Hopkins University

CTReP@jhmi.edu

410-502-7546

Study Officials

• Anna Chien

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 24, 2017
• Study Start: September 15, 2017
• Primary Completion: January 18, 2019
• Study Completion: January 18, 2019
• Last Updated: June 29, 2023
• Results First Posted: February 25, 2020

Record last verified: 2023-06

Locations

US (1)