AgingPhase 2NCT03126539

Effect of Topical Sulforaphane on Skin Fragility Seen in Skin Aging and With Ultraviolet Exposure

A Phase 2 study testing Sulforaphane, Narrow-band Ultraviolet B exposure and 4 mm skin punch biopsy in people with Aging, run by Johns Hopkins University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study aims to compare the expression of keratins before and after application of sulforaphane (SF) to determine whether this agent alters skin fragility seen in both intrinsic and extrinsic skin aging and UV light exposure. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Aging
What is being tested?: Sulforaphane, Narrow-band Ultraviolet B exposure and 4 mm skin punch biopsy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 15 Sep 2017to 18 Jan 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Participants must be over the age of 18 years old with healthy skin;
Must be healthy enough to undergo skin biopsy, UV light irradiation, and other study procedures in the opinion of the investigator;
Must be willing to comply with the requirements of the protocol;
Must have the ability to understand and communicate with the investigator;
Participant must provide informed consent.

Who cannot join

Subjects who are unable to provide informed consent;
Subject with significant medical history or current skin diseases that the investigator feels is not safe for study participation;
Subjects who have been treated with systemic retinoids or steroids within the past month prior to entry to the study;
Subjects who have been treated with topical steroids, retinoids or other topical drugs used within 2 weeks prior to entry to the study;
Recently treated or current skin diseases that would affect clinical evaluation and biopsy;
Subjects with a known allergy to broccoli.

Show all 11Show fewer

Presence or suspicion of bleeding disorder or diathesis which would complicate biopsy.
Subjects with a history of excessive scar or keloid formation in the past 10 years.
Pregnant or nursing subjects (self-reported).
Subjects with known allergy to anesthetics used.
Patients with history of investigational drug use in the 30 days prior to entry into the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cutaneous Translational Research Program, Department of Dermatology, Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287

Other trials in United States

About this study

Read the detailed description

The primary purpose of the study is to compare the expression of keratins before and after application of sulforaphane (SF) and determine whether these findings alter skin fragility seen in both intrinsic and extrinsic skin aging as well as in ultraviolet (UV) light exposure.

This investigation will be done in collaboration with researchers from the Department of Biochemistry and Molecular Biology and Bloomberg School of Public Health at Johns Hopkins University. The study population recruited by Johns Hopkins Department of Dermatology will include up to 50 individuals over the age of 18 with healthy skin. Each study participant will have four on-site study visits and will be asked to contribute photographs, undergo non invasive elasticity measurements, use topical sulforaphane for 7 days and contribute up to four biopsy specimens for laboratory study. The investigators will also evaluate any differences in keratins' expression in skin exposed to acute UV light, separately and after pretreatment with sulforaphane.

Conditions: Aging
Being tested: Sulforaphane, Narrow-band Ultraviolet B exposure, 4 mm skin punch biopsy
Keywords: aging, ultraviolet exposure, skin fragility, sulforaphane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SulforaphaneDrug
Also called Broccoli sprout extract; isothiocyanate sulforaphane
Isothiocyanate sulforaphane (SF), derived from broccoli sprouts, has been known to induce an antioxidant response through the Keap1-Nrf2-antioxidant response element pathway.
Narrow-band Ultraviolet B exposureRadiation
Also called UVB, UV
The investigators will use a Lumera ultraviolet B (UVB) light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320 nm).
4 mm skin punch biopsyProcedure or surgery
Also called biopsy
All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than four total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications and blends well with the surrounding skin.

Study groups in NCT03126539
Study group	Role	What they receive
Group A	Experimental	Sulforaphane will be applied topically to both sites for up to 7 consecutive nights. Biopsies will be obtained prior to, and immediately after this intervention, on standard photoprotected and photoexposed sites. Receives: Drug: Sulforaphane; Procedure: 4 mm skin punch biopsy
Group B	Experimental	Two photoprotected sites will be identified. Sulforaphane will be applied topically to a single selected site for up to 7 consecutive nights. Both site will be exposed to UV. Biopsies of both sites will be obtained prior to, and 24 hours after UV exposure. Receives: Drug: Sulforaphane; Radiation: Narrow-band Ultraviolet B exposure; Procedure: 4 mm skin punch biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Change Score for Mottled Hyperpigmentation
Clinical assessment of mottled hyperpigmentation pre and post Sulforaphane (SF) treatment will be done for both photoprotected and photodamaged skin treated with sulforaphane. Mottled Hyperpigmentation Score system will be applied, with scale of 0 to 4, 4= clear improvement after 1 week of SF or placebo application.
Measured: Clinical Change Score for Mottled Hyperpigmentation , up to 1 week

Secondary outcomes (2)

Gene Expression Changes as Assessed by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR)
We will measure the fold-change in gene expression in human skin after acute UV light exposure, separately and in combination with application of topical sulforaphane using RT-PCR.
Measured: Up to 6 months
Gene Expression Changes as Assessed by Immunohistochemistry (IHC)
We will measure the fold-change in gene expression in human skin after acute UV light exposure, separately and in combination with application of topical sulforaphane using IHC.
Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 201718 Jan 2019

First posted24 Apr 2017
Study start15 Sep 2017
Primary completion18 Jan 2019
Study completion18 Jan 2019

Why it stopped: For administrative reasons, we started a new study

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AgingStudies 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 2
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03126539
Sponsor's protocol ID: IRB00105668
Status last verified: Jun 2023
First submitted: 7 Apr 2017
Last updated: 29 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Topical Sulforaphane on Skin Fragility Seen in Skin Aging and With Ultraviolet Exposure
ClinicalTrials.gov ID: NCT03126539
Acronym / sponsor ID: IRB00105668
Conditions: Aging
Keywords: aging, ultraviolet exposure, skin fragility, sulforaphane
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: For administrative reasons, we started a new study
Enrolment: 9 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Study start: 15 Sep 2017 (actual)
Primary completion: 18 Jan 2019 (actual)
Study completion: 18 Jan 2019 (actual)
First posted: 24 Apr 2017 (actual)
Results: Posted 25 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Drug: Sulforaphane, Procedure: 4 mm skin punch biopsySulforaphane will be applied topically to both sites for up to 7 consecutive nights. Biopsies will be obtained prior to, and immediately after this intervention, on standard photoprotected and photoexposed sites.
Group B	Experimental	Drug: Sulforaphane, Radiation: Narrow-band Ultraviolet B exposure, Procedure: 4 mm skin punch biopsyTwo photoprotected sites will be identified. Sulforaphane will be applied topically to a single selected site for up to 7 consecutive nights. Both site will be exposed to UV. Biopsies of both sites will be obtained prior to, and 24 hours after UV exposure.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Participants must be over the age of 18 years old with healthy skin;
Must be healthy enough to undergo skin biopsy, UV light irradiation, and other study procedures in the opinion of the investigator;
Must be willing to comply with the requirements of the protocol;
Must have the ability to understand and communicate with the investigator;
Participant must provide informed consent.

Key exclusion criteria (11 listed)

Subjects who are unable to provide informed consent;
Subject with significant medical history or current skin diseases that the investigator feels is not safe for study participation;
Subjects who have been treated with systemic retinoids or steroids within the past month prior to entry to the study;
Subjects who have been treated with topical steroids, retinoids or other topical drugs used within 2 weeks prior to entry to the study;
Recently treated or current skin diseases that would affect clinical evaluation and biopsy;

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
SulforaphaneAlso: Broccoli sprout extract; isothiocyanate sulforaphaneIsothiocyanate sulforaphane (SF), derived from broccoli sprouts, has been known to induce an antioxidant response through the Keap1-Nrf2-antioxidant response element pathway.	Drug	Group A, Group B
Narrow-band Ultraviolet B exposureAlso: UVB, UVThe investigators will use a Lumera ultraviolet B (UVB) light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320 nm).	Radiation	Group B
4 mm skin punch biopsyAlso: biopsyAll areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than four total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications and blends well with the surrounding skin.	Procedure or surgery	Group A, Group B

Primary outcome

Clinical Change Score for Mottled Hyperpigmentation
Time frame: Clinical Change Score for Mottled Hyperpigmentation , up to 1 week
Clinical assessment of mottled hyperpigmentation pre and post Sulforaphane (SF) treatment will be done for both photoprotected and photodamaged skin treated with sulforaphane. Mottled Hyperpigmentation Score system will be applied, with scale of 0 to 4, 4= clear improvement after 1 week of SF or placebo application.

2 secondary outcomes

Gene Expression Changes as Assessed by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Time frame: Up to 6 months
Gene Expression Changes as Assessed by Immunohistochemistry (IHC)
Time frame: Up to 6 months

Results and safety

Results posted to the registry on 25 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: No UV Exposure - Sulforaphane	9	8
Group A: No UV Exposure - Placebo	9	8
Group A: No UV Exposure - No Treatment Control	9	8
Group B With UV Exposure - Sulforaphane	0	0
Group B With UV Exposure - Placebo	0	0

Primary outcome: Clinical Change Score for Mottled Hyperpigmentation

Time frame: Clinical Change Score for Mottled Hyperpigmentation , up to 1 week. Mean (Standard Error). Unit: score on a scale

Measure	Group A: No UV Exposure - Sulforaphane n = 8	Group A: No UV Exposure - Placebo n = 8	Group A: No UV Exposure - No Treatment Control n = 9	Group B With UV Exposure - Sulforaphane n = 0	Group B With UV Exposure - Placebo n = 0
Value	2.8 (0.4)	.94 (.2)	0 (0)	–	–

Population analysed: We did not enroll any participant in group B. The results we got were not the comparison between no UV exposure group and UV exposure. Instead, the results were the clinical change score between the SF treated skin spots and no SF treated (placebo) skin spots of each participant.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Four weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A: No UV Exposure	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Group B With UV Exposure	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Anna Chien principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sulforaphane, Narrow-band Ultraviolet B exposure and 4 mm skin punch biopsy in people with Aging, 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 29 Jun 2023. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Clinical Change Score for Mottled Hyperpigmentation (time frame: Clinical Change Score for Mottled Hyperpigmentation , up to 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03126539.

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 29 Jun 2023.