Skin AgingEarly Phase 1NCT03730649
Effect of Topical Sulforaphane on Skin Aging and With Ultraviolet and Visible Light Exposure
A Early Phase 1 study testing Sulforaphane (broccoli sprout extract) and UV or visible light in people with Skin Aging, run by Johns Hopkins University at 1 site in United States.
Trial summary
The study is to compare the expression of both keratin 16 and 17 before and after application of sulforaphane on both photoprotected and photoexposed area, and to determine whether these findings alter skin aging as well as skin response to ultraviolet (UV) and visible 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
- Skin Aging
- What is being tested?
- Sulforaphane (broccoli sprout extract) and UV or visible light
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2019to Oct 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 or moderate degree of photoaging/intrinsic aging;
- Must be healthy enough to undergo skin biopsy, 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
About this study
The study is to compare the expression of both keratin 16 and 17 before and after application of sulforaphane on both photoprotected and photoexposed area, and to determine whether these findings alter skin aging as well as skin response to ultraviolet (UV) and visible light exposure.
Read the detailed description
The study is to compare the expression of both keratin 16 and 17 before and after application of sulforaphane on both photoprotected and photoexposed area, and to determine whether these findings alter skin aging as well as skin response to ultraviolet (UV) and visible light exposure.
Each study participant will have up to eight study visits. Topical sulforaphane will be applied for up to 6 months. Photography, clinical assessment, UV light irradiation, Visible light treatment, Skin biopsies, non invasive elasticity measurements such as cutometer and ballistometer, and others will be involved in this study.
- Conditions
- Skin Aging
- Being tested
- Sulforaphane (broccoli sprout extract), UV or visible light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulforaphane (broccoli sprout extract)Drug
Participants will topically apply Sulforaphane for a period of time
UV or visible lightRadiation
Participants will have 2 test areas irradiated with up to 5 UV or visible light treatments
| Study group | Role | What they receive |
|---|---|---|
| Sulforaphane without light challenge | Active comparator | Participants with moderate photodamage and moderate intrinsic skin aging will apply sulforaphane (broccoli sprout extract) in jojoba oil nightly (without any UV or visible light irradiation) for up to 6 months and have up to 9 biopsies taken just before treatment and occurring at regular intervals during the study Receives: Drug: Sulforaphane (broccoli sprout extract) |
| Sulforaphane with light challenge | Active comparator | Participants will have 2 test areas irradiated with up to 5 UV or visible light treatments and biopsies taken before and within 7 days after UV or visible light irradiation; one of the UV/visible light treated areas will be pre-treated with sulforaphane (broccoli sprout extract) for up to 28 consecutive nights and the other UV/visible light treated areas will be pre-treated with jojoba oil. Receives: Drug: Sulforaphane (broccoli sprout extract); Radiation: UV or visible light |
What is being measured
The primary outcome is the main question the study is designed to answer.
keratin 16 presence as determined by immunofluorescence assay
The investigators will detect the presence of keratin 16 in the basal layer of the epidermis in both photoprotected and photodamaged skin treated with sulforaphane (SF), by immunofluorescence assay, to determine whether SF can improve skin fragility and other features seen in these conditions
Measured: Up to 6 months
keratin 17 presence as determined by immunofluorescence assay
The investigators will detect the presence of keratin 17 in the basal layer of the epidermis in both photoprotected and photodamaged skin treated with SF, by immunofluorescence assay, to determine whether SF can improve skin fragility and other features seen in these conditions
Measured: Up to 6 months
keratin 16 fold change as determined by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
The investigators will detect the fold change of keratin 16 in the basal layer of the epidermis in both photoprotected and photodamaged skin treated with SF, by RT-PCR, to determine whether SF can improve skin fragility and other features seen in these conditions
Measured: Up to 6 months
keratin 17 fold change as determined by RT-PCR
The investigators will detect the fold change of keratin 17 in the basal layer of the epidermis in both photoprotected and photodamaged skin treated with sulforaphane (SF), by RT-PCR, to determine whether SF can improve skin fragility and other features seen in these conditions
Measured: Up to 6 months
Secondary outcomes (1)
keratin expression changes as determined by RT-PCR
The investigators will test the fold change of keratin expression in human skin after acute UV and visible light light exposure, separately and in combination with application of topical sulforaphane by RT-PCR.
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.
- First posted5 Nov 2018
- Study start9 Oct 2019
- Primary completion1 Mar 2025
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Skin 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Chien, Principal investigator, Department of Dermatology, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730649
- Sponsor's protocol ID
- IRB00184806
- Status last verified
- Sep 2026
- First submitted
- 2 Nov 2018
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dinkova-Kostova AT, Talalay P, Sharkey J, Zhang Y, Holtzclaw WD, Wang XJ, David E, Schiavoni KH, Finlayson S, Mierke DF, Honda T. An exceptionally potent inducer of cytoprotective enzymes: elucidation of the structural features that determine inducer potency and reactivity with Keap1. J Biol Chem. 2010 Oct 29;285(44):33747-55. doi: 10.1074/jbc.M110.163485. Epub 2010 Aug 26.
PubMed 20801881Talalay P, Fahey JW, Healy ZR, Wehage SL, Benedict AL, Min C, Dinkova-Kostova AT. Sulforaphane mobilizes cellular defenses that protect skin against damage by UV radiation. Proc Natl Acad Sci U S A. 2007 Oct 30;104(44):17500-5. doi: 10.1073/pnas.0708710104. Epub 2007 Oct 23.
PubMed 17956979Shapiro TA, Fahey JW, Dinkova-Kostova AT, Holtzclaw WD, Stephenson KK, Wade KL, Ye L, Talalay P. Safety, tolerance, and metabolism of broccoli sprout glucosinolates and isothiocyanates: a clinical phase I study. Nutr Cancer. 2006;55(1):53-62. doi: 10.1207/s15327914nc5501_7.
PubMed 16965241Egner PA, Chen JG, Wang JB, Wu Y, Sun Y, Lu JH, Zhu J, Zhang YH, Chen YS, Friesen MD, Jacobson LP, Munoz A, Ng D, Qian GS, Zhu YR, Chen TY, Botting NP, Zhang Q, Fahey JW, Talalay P, Groopman JD, Kensler TW. Bioavailability of Sulforaphane from two broccoli sprout beverages: results of a short-term, cross-over clinical trial in Qidong, China. Cancer Prev Res (Phila). 2011 Mar;4(3):384-95. doi: 10.1158/1940-6207.CAPR-10-0296.
PubMed 21372038Singh K, Connors SL, Macklin EA, Smith KD, Fahey JW, Talalay P, Zimmerman AW. Sulforaphane treatment of autism spectrum disorder (ASD). Proc Natl Acad Sci U S A. 2014 Oct 28;111(43):15550-5. doi: 10.1073/pnas.1416940111. Epub 2014 Oct 13.
PubMed 25313065Kerns ML, DePianto D, Dinkova-Kostova AT, Talalay P, Coulombe PA. Reprogramming of keratin biosynthesis by sulforaphane restores skin integrity in epidermolysis bullosa simplex. Proc Natl Acad Sci U S A. 2007 Sep 4;104(36):14460-5. doi: 10.1073/pnas.0706486104. Epub 2007 Aug 27.
PubMed 17724334Sikdar S, Papadopoulou M, Dubois J. What do we know about sulforaphane protection against photoaging? J Cosmet Dermatol. 2016 Mar;15(1):72-7. doi: 10.1111/jocd.12176. Epub 2016 Jan 22.
PubMed 26799467
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Sulforaphane on Skin Aging and With Ultraviolet and Visible Light Exposure
- ClinicalTrials.gov ID
- NCT03730649
- Acronym / sponsor ID
- IRB00184806
- Conditions
- Skin Aging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- Oct 2027 (estimated)
- First posted
- 5 Nov 2018 (actual)
- 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.
The study is to compare the expression of both keratin 16 and 17 before and after application of sulforaphane on both photoprotected and photoexposed area, and to determine whether these findings alter skin aging as well as skin response to ultraviolet (UV) and visible light exposure.
Detailed description
The study is to compare the expression of both keratin 16 and 17 before and after application of sulforaphane on both photoprotected and photoexposed area, and to determine whether these findings alter skin aging as well as skin response to ultraviolet (UV) and visible light exposure.
Each study participant will have up to eight study visits. Topical sulforaphane will be applied for up to 6 months. Photography, clinical assessment, UV light irradiation, Visible light treatment, Skin biopsies, non invasive elasticity measurements such as cutometer and ballistometer, and others will be involved in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sulforaphane without light challenge | Active comparator | Drug: Sulforaphane (broccoli sprout extract)Participants with moderate photodamage and moderate intrinsic skin aging will apply sulforaphane (broccoli sprout extract) in jojoba oil nightly (without any UV or visible light irradiation) for up to 6 months and have up to 9 biopsies taken just before treatment and occurring at regular intervals during the study |
| Sulforaphane with light challenge | Active comparator | Drug: Sulforaphane (broccoli sprout extract), Radiation: UV or visible lightParticipants will have 2 test areas irradiated with up to 5 UV or visible light treatments and biopsies taken before and within 7 days after UV or visible light irradiation; one of the UV/visible light treated areas will be pre-treated with sulforaphane (broccoli sprout extract) for up to 28 consecutive nights and the other UV/visible light treated areas will be pre-treated with jojoba oil. |
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 or moderate degree of photoaging/intrinsic aging;
- Must be healthy enough to undergo skin biopsy, 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 |
|---|---|---|
| Sulforaphane (broccoli sprout extract)Participants will topically apply Sulforaphane for a period of time | Drug | Sulforaphane with light challenge, Sulforaphane without light challenge |
| UV or visible lightParticipants will have 2 test areas irradiated with up to 5 UV or visible light treatments | Radiation | Sulforaphane with light challenge |
Primary outcome
keratin 16 presence as determined by immunofluorescence assay
Time frame: Up to 6 months
The investigators will detect the presence of keratin 16 in the basal layer of the epidermis in both photoprotected and photodamaged skin treated with sulforaphane (SF), by immunofluorescence assay, to determine whether SF can improve skin fragility and other features seen in these conditions
keratin 17 presence as determined by immunofluorescence assay
Time frame: Up to 6 months
The investigators will detect the presence of keratin 17 in the basal layer of the epidermis in both photoprotected and photodamaged skin treated with SF, by immunofluorescence assay, to determine whether SF can improve skin fragility and other features seen in these conditions
keratin 16 fold change as determined by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Time frame: Up to 6 months
The investigators will detect the fold change of keratin 16 in the basal layer of the epidermis in both photoprotected and photodamaged skin treated with SF, by RT-PCR, to determine whether SF can improve skin fragility and other features seen in these conditions
keratin 17 fold change as determined by RT-PCR
Time frame: Up to 6 months
The investigators will detect the fold change of keratin 17 in the basal layer of the epidermis in both photoprotected and photodamaged skin treated with sulforaphane (SF), by RT-PCR, to determine whether SF can improve skin fragility and other features seen in these conditions
1 secondary outcome
keratin expression changes as determined by RT-PCR
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 20801881Dinkova-Kostova AT, Talalay P, Sharkey J, Zhang Y, Holtzclaw WD, Wang XJ, David E, Schiavoni KH, Finlayson S, Mierke DF, Honda T. An exceptionally potent inducer of cytoprotective enzymes: elucidation of the structural features that determine inducer potency and reactivity with Keap1. J Biol Chem. 2010 Oct 29;285(44):33747-55. doi: 10.1074/jbc.M110.163485. Epub 2010 Aug 26.
- Background: PubMed 17956979Talalay P, Fahey JW, Healy ZR, Wehage SL, Benedict AL, Min C, Dinkova-Kostova AT. Sulforaphane mobilizes cellular defenses that protect skin against damage by UV radiation. Proc Natl Acad Sci U S A. 2007 Oct 30;104(44):17500-5. doi: 10.1073/pnas.0708710104. Epub 2007 Oct 23.
- Background: PubMed 16965241Shapiro TA, Fahey JW, Dinkova-Kostova AT, Holtzclaw WD, Stephenson KK, Wade KL, Ye L, Talalay P. Safety, tolerance, and metabolism of broccoli sprout glucosinolates and isothiocyanates: a clinical phase I study. Nutr Cancer. 2006;55(1):53-62. doi: 10.1207/s15327914nc5501_7.
- Background: PubMed 21372038Egner PA, Chen JG, Wang JB, Wu Y, Sun Y, Lu JH, Zhu J, Zhang YH, Chen YS, Friesen MD, Jacobson LP, Munoz A, Ng D, Qian GS, Zhu YR, Chen TY, Botting NP, Zhang Q, Fahey JW, Talalay P, Groopman JD, Kensler TW. Bioavailability of Sulforaphane from two broccoli sprout beverages: results of a short-term, cross-over clinical trial in Qidong, China. Cancer Prev Res (Phila). 2011 Mar;4(3):384-95. doi: 10.1158/1940-6207.CAPR-10-0296.
- Background: PubMed 25313065Singh K, Connors SL, Macklin EA, Smith KD, Fahey JW, Talalay P, Zimmerman AW. Sulforaphane treatment of autism spectrum disorder (ASD). Proc Natl Acad Sci U S A. 2014 Oct 28;111(43):15550-5. doi: 10.1073/pnas.1416940111. Epub 2014 Oct 13.
- Background: PubMed 17724334Kerns ML, DePianto D, Dinkova-Kostova AT, Talalay P, Coulombe PA. Reprogramming of keratin biosynthesis by sulforaphane restores skin integrity in epidermolysis bullosa simplex. Proc Natl Acad Sci U S A. 2007 Sep 4;104(36):14460-5. doi: 10.1073/pnas.0706486104. Epub 2007 Aug 27.
- Background: PubMed 26799467Sikdar S, Papadopoulou M, Dubois J. What do we know about sulforaphane protection against photoaging? J Cosmet Dermatol. 2016 Mar;15(1):72-7. doi: 10.1111/jocd.12176. Epub 2016 Jan 22.
- Individual participant dataSharing planned: No
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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
Department of Dermatology, Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sulforaphane (broccoli sprout extract) and UV or visible light in people with Skin 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
keratin 16 presence as determined by immunofluorescence assay (time frame: Up to 6 months). The study lists 4 primary outcomes in all. 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 NCT03730649, which also lists 7 linked publications.
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 4 Sep 2026.