Effect of Topical Sulforaphane on Skin Fragility Seen in Skin Aging and With Ultraviolet Exposure
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ClinicalTrials.gov Identifier: NCT03126539 |
Recruitment Status :
Terminated
(For administrative reasons, we started a new study)
First Posted : April 24, 2017
Results First Posted : February 25, 2020
Last Update Posted : February 25, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | April 7, 2017 | ||||
First Posted Date ICMJE | April 24, 2017 | ||||
Results First Submitted Date ICMJE | November 22, 2019 | ||||
Results First Posted Date ICMJE | February 25, 2020 | ||||
Last Update Posted Date | February 25, 2020 | ||||
Actual Study Start Date ICMJE | September 15, 2017 | ||||
Actual Primary Completion Date | January 25, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
Quantitative RT-PCR and Immunohistochemistry to assess Keratin 16 and 17 induction in the basal epidermis. [ Time Frame: Within 6 months after last patient recruited. ] We quantify the induction as measured by fold-change of keratin 16 and keratin 17 in the basal layer of the epidermis in both photoprotected and photodamaged skin treated with sulforaphane.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Quantitative RT-PCR and Immunohistochemistry to assess gene expression changes [ Time Frame: Within 6 months after last patient recruited. ] 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.
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effect of Topical Sulforaphane on Skin Fragility Seen in Skin Aging and With Ultraviolet Exposure | ||||
Official Title ICMJE | Effect of Topical Sulforaphane on Skin Fragility Seen in Skin Aging and With Ultraviolet Exposure | ||||
Brief 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. | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other |
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Condition ICMJE | Aging | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
9 | ||||
Original Estimated Enrollment ICMJE |
50 | ||||
Actual Study Completion Date ICMJE | January 25, 2019 | ||||
Actual Primary Completion Date | January 25, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03126539 | ||||
Other Study ID Numbers ICMJE | IRB00105668 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Johns Hopkins University | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Johns Hopkins University | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Johns Hopkins University | ||||
Verification Date | February 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |