Effect of Broccoli Sprout Extract on Keratinocyte Differentiation in Normal Skin

NCT02592954 | Completed Phase 1 DMC

• 1 other identifier: BSE2015
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Epidermolysis Bullosa Simplex; Pachyonychia Congenita

Outcome Measures

Primary Outcomes (2)

• Immunohistochemistry

  Immunohistochemistry of protein levels of keratin 1, keratin 5, keratin 10, keratin 14, keratin 16, keratin 17, and Nrf2

  Within 1 month of skin biopsy

• 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

  Within 1 month of skin biopsy

Secondary Outcomes (1)

• Adverse Events

  During the trial until 2 months after the trial ends

Study Arms (2)

Jojoba oil with broccoli sprout extract

EXPERIMENTAL

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

Jojoba oil

PLACEBO COMPARATOR

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

Drug: Jojoba oil (placebo)

Interventions

Jojoba oil with broccoli sprout extract DRUG

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

Jojoba oil with broccoli sprout extract

Jojoba oil (placebo) DRUG

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

Jojoba oil

Eligibility Criteria

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

You may qualify if:

• Able to attend 3 visits at the designated times.

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Epidermolysis Bullosa Simplex; Pachyonychia Congenita

Interventions

jojoba wax

Condition Hierarchy (Ancestors)

Epidermolysis Bullosa; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous; Ectodermal Dysplasia; Abnormalities, Multiple; Nail Diseases

Study Officials

• Bernard Cohen, MD

  Professor of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: October 30, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 6, 2017

Record last verified: 2017-12

Locations

US (1)