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Effect of Broccoli Sprout Extract on Keratinocyte Differentiation in Normal Skin

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2015 by Bernard Cohen, Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Bernard Cohen, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02592954
First received: October 29, 2015
Last updated: NA
Last verified: October 2015
History: No changes posted
  Purpose
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 Intervention Phase
Epidermolysis Bullosa Simplex Pachyonychia Congenita Drug: Jojoba oil with broccoli sprout extract Drug: Jojoba oil (placebo) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: Effect of Broccoli Sprout Extract on Keratinocyte Differentiation in Normal Skin

Resource links provided by NLM:


Further study details as provided by Bernard Cohen, Johns Hopkins University:

Primary Outcome Measures:
  • 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

  • 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:
  • 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


Estimated Enrollment: 10
Study Start Date: September 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02592954

Contacts
Contact: Bernard Cohen, MD 410-955-5933 bcohena@jhmi.edu
Contact: Lark Guss, MD 760-831-9758 lgreenw5@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Bernard Cohen, MD    410-955-5933    bcohena@jhmi.edu   
Contact: Lark Guss, MD    760-831-9758    lgreenw5@jhmi.edu   
Principal Investigator: Bernard Cohen, MD         
Sub-Investigator: Lark Guss, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Bernard Cohen, MD Professor of Dermatology
  More Information

Responsible Party: Bernard Cohen, Professor of Pediatric Dermatology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02592954     History of Changes
Other Study ID Numbers: BSE2015
Study First Received: October 29, 2015
Last Updated: October 29, 2015

Additional relevant MeSH terms:
Epidermolysis Bullosa
Epidermolysis Bullosa Simplex
Nails, Malformed
Pachyonychia Congenita
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous
Pathological Conditions, Anatomical
Ectodermal Dysplasia
Nail Diseases

ClinicalTrials.gov processed this record on August 22, 2017