Epidermolysis Bullosa SimplexPhase 1NCT02592954
Effect of Broccoli Sprout Extract on Keratinocyte Differentiation in Normal Skin
A Phase 1 study testing Jojoba oil with broccoli sprout extract in people with Epidermolysis Bullosa Simplex and Pachyonychia Congenita, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epidermolysis Bullosa Simplex, Pachyonychia Congenita
- What is being tested?
- Jojoba oil with broccoli sprout extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to attend 3 visits at the designated times.
Who cannot join
- Pregnant
- Known allergy to broccoli, lidocaine, or epinephrine
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Jojoba oil with broccoli sprout extract, Jojoba oil (placebo)
- Medical subject headings
- Epidermolysis Bullosa Simplex, Pachyonychia Congenita
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jojoba oil with broccoli sprout extractDrug
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 (placebo)Drug
1ml of jojoba oil will be applied to the same arm every night under saran wrap for 1 week
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Jojoba oil (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunohistochemistry
Immunohistochemistry of protein levels of keratin 1, keratin 5, keratin 10, keratin 14, keratin 16, keratin 17, and Nrf2
Measured: 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
Measured: Within 1 month of skin biopsy
Secondary outcomes (1)
Adverse Events
Any adverse events associated with topical application of the drug or placebo
Measured: During the trial until 2 months after the trial ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermolysis Bullosa SimplexStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard Cohen, MD, Principal investigator, Professor of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592954
- Sponsor's protocol ID
- BSE2015
- Status last verified
- Dec 2017
- First submitted
- 29 Oct 2015
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Broccoli Sprout Extract on Keratinocyte Differentiation in Normal Skin
- ClinicalTrials.gov ID
- NCT02592954
- Acronym / sponsor ID
- BSE2015
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jojoba oil with broccoli sprout extract | Experimental | Drug: Jojoba oil with broccoli sprout extract500nmol 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 | Placebo comparator | Drug: Jojoba oil (placebo)1ml of jojoba oil will be applied to the same arm every night under saran wrap for 1 week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Able to attend 3 visits at the designated times.
Key exclusion criteria (2 listed)
- Pregnant
- Known allergy to broccoli, lidocaine, or epinephrine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jojoba oil with broccoli sprout extract500nmol 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)1ml of jojoba oil will be applied to the same arm every night under saran wrap for 1 week | Drug | Jojoba oil |
Primary outcome
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
1 secondary outcome
Adverse Events
Time frame: During the trial until 2 months after the trial ends
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Cohen, MD principal investigator
Professor of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Jojoba oil with broccoli sprout extract in people with Epidermolysis Bullosa Simplex and Pachyonychia Congenita, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunohistochemistry (time frame: Within 1 month of skin biopsy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.