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Effect of Broccoli Sprout Extract on Keratinocyte Differentiation in Normal Skin

Primary Purpose

Epidermolysis Bullosa Simplex, Pachyonychia Congenita

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Jojoba oil with broccoli sprout extract
Jojoba oil (placebo)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Epidermolysis Bullosa Simplex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Able to attend 3 visits at the designated times.

Exclusion Criteria:

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

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Jojoba oil with broccoli sprout extract

Jojoba oil

Arm Description

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

1ml of jojoba oil will be applied to the same arm every night under saran wrap for 1 week

Outcomes

Primary Outcome Measures

Immunohistochemistry
Immunohistochemistry of protein levels of keratin 1, keratin 5, keratin 10, keratin 14, keratin 16, keratin 17, and Nrf2
Real time- Polymerase Chain Reaction
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

Adverse Events
Any adverse events associated with topical application of the drug or placebo

Full Information

First Posted
October 29, 2015
Last Updated
December 4, 2017
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02592954
Brief Title
Effect of Broccoli Sprout Extract on Keratinocyte Differentiation in Normal Skin
Official Title
Effect of Broccoli Sprout Extract on Keratinocyte Differentiation in Normal Skin
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidermolysis Bullosa Simplex, Pachyonychia Congenita

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Jojoba oil with broccoli sprout extract
Arm Type
Experimental
Arm Description
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
Arm Title
Jojoba oil
Arm Type
Placebo Comparator
Arm Description
1ml of jojoba oil will be applied to the same arm every night under saran wrap for 1 week
Intervention Type
Drug
Intervention Name(s)
Jojoba oil with broccoli sprout extract
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Jojoba oil (placebo)
Intervention Description
1ml of jojoba oil will be applied to the same arm every night under saran wrap for 1 week
Primary Outcome Measure Information:
Title
Immunohistochemistry
Description
Immunohistochemistry of protein levels of keratin 1, keratin 5, keratin 10, keratin 14, keratin 16, keratin 17, and Nrf2
Time Frame
Within 1 month of skin biopsy
Title
Real time- Polymerase Chain Reaction
Description
Real time- Polymerase Chain Reaction of protein levels of keratin 1, keratin 5, keratin 10, keratin 14, keratin 16, keratin 17, and Nrf2
Time Frame
Within 1 month of skin biopsy
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Any adverse events associated with topical application of the drug or placebo
Time Frame
During the trial until 2 months after the trial ends

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Able to attend 3 visits at the designated times. Exclusion Criteria: Pregnant Known allergy to broccoli, lidocaine, or epinephrine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Cohen, MD
Organizational Affiliation
Professor of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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Effect of Broccoli Sprout Extract on Keratinocyte Differentiation in Normal Skin

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