Effect of Broccoli Sprout Extract on Keratinocyte Differentiation in Normal Skin

• ClinicalTrials.gov Identifier: NCT02592954
• Recruitment Status: Completed
• First Posted: October 30, 2015
• Last Update Posted: December 6, 2017
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

Brief Summary:

Adult participants will apply a broccoli sprout extract-jojoba oil compound to one arm every night under occlusion for 1 week. Jojoba oil alone will be applied to the other arm. At the end of 1 week, a 6mm punch biopsy will be taken from both arms and analyzed via polymerase chain reaction (PCR) and immunohistochemistry for differences in various skin proteins.

Condition or disease	Intervention/treatment	Phase
Epidermolysis Bullosa Simplex; Pachyonychia Congenita	Drug: Jojoba oil with broccoli sprout extract; Drug: Jojoba oil (placebo)	Phase 1

Detailed Description:

10 adult volunteers, including African American, Caucasian, male and female participants, will be recruited from parents of patients seen in the pediatric dermatology clinic. Each participant will receive 7ml of broccoli sprout extract (BSE) in jojoba oil, containing 3500nmol of sulforaphane (Please see the preparation of broccoli sprout extract below). 500nmol of sulforaphane will be applied each night. The participants will apply the BSE-jojoba oil mixture over a circle, 3cm in diameter, on the upper arm every night for 7 consecutive nights. The control arm will have only jojoba oil applied. Both arms will be occluded with saran wrap every night. After the seventh night, the volunteers will have a 6mm biopsy taken from each arm (2 total), performed by a dermatology resident. The biopsies will be cleaned with alcohol, numbed with 0.5-1cc of 1% lidocaine with epinephrine, and closed with one 4-0 nylon nonabsorbable suture. The biopsy site will be covered with Vaseline and a bandaid. The area will be kept covered for 24 hours, after which it may be washed with soap and water and then recovered with Vaseline and a bandaid. The suture will be removed 10-14 days after the procedure. From the initial visit through the final visit for suture removal, we expect the duration of the trial to last approximately 1 month. The participants will be told to avoid applying any topical medications or over the counter lotions or creams for the duration of the study and will also be told to wash with Dove soap in the shower. They will also be advised to avoid a diet high in cruciferous plants such as broccoli, mustard, and horseradish. The biopsy results will each be divided in half. One half to be frozen for cryosectioning and immunofluorescence staining and the other half to be used for protein or RNA extraction for molecular assays (real time polymerase chain reaction and/or quantitative polymerase chain reaction for select messenger RNAs and western blotting for select protein antigens). The levels of keratin 1, keratin 5, keratin 10, keratin 14, keratin 16, keratin 17, and Nrf2 will be studied with both immunofluorescence and RNA PCR.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Effect of Broccoli Sprout Extract on Keratinocyte Differentiation in Normal Skin
• Study Start Date: September 2015
• Actual Primary Completion Date: December 2016
• Actual Study Completion Date: December 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Jojoba oil with broccoli sprout extract; 500nmol of broccoli sprout extract in 1ml of jojoba oil will be applied to the same arm every night under saran wrap for 1 week	Drug: Jojoba oil with broccoli sprout extract; 500nmol of broccoli sprout extract in 1ml of jojoba oil will be applied to the same arm every night under saran wrap for 1 week
Placebo Comparator: Jojoba oil; 1ml of jojoba oil will be applied to the same arm every night under saran wrap for 1 week	Drug: Jojoba oil (placebo); 1ml of jojoba oil will be applied to the same arm every night under saran wrap for 1 week

Outcome Measures

Primary Outcome Measures :

1. Immunohistochemistry [ Time Frame: Within 1 month of skin biopsy ]
   Immunohistochemistry of protein levels of keratin 1, keratin 5, keratin 10, keratin 14, keratin 16, keratin 17, and Nrf2
2. Real time- Polymerase Chain Reaction [ Time Frame: Within 1 month of skin biopsy ]
   Real time- Polymerase Chain Reaction of protein levels of keratin 1, keratin 5, keratin 10, keratin 14, keratin 16, keratin 17, and Nrf2

Secondary Outcome Measures :

1. Adverse Events [ Time Frame: During the trial until 2 months after the trial ends ]
   Any adverse events associated with topical application of the drug or placebo

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Able to attend 3 visits at the designated times.

Exclusion Criteria:

• Pregnant
• Known allergy to broccoli, lidocaine, or epinephrine

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Johns Hopkins University

Investigators

• Principal Investigator: Bernard Cohen, MD; Professor of Dermatology

More Information

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02592954
• Other Study ID Numbers: BSE2015
• First Posted: October 30, 2015
• Last Update Posted: December 6, 2017
• Last Verified: December 2017

Additional relevant MeSH terms:

Epidermolysis Bullosa; Epidermolysis Bullosa Simplex; Pachyonychia Congenita; Nails, Malformed; Skin Abnormalities; Congenital Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases; Skin Diseases, Vesiculobullous; Pathological Conditions, Anatomical; Ectodermal Dysplasia; Abnormalities, Multiple; Nail Diseases