Clinical trial NCT03126539: Effect of Topical Sulforaphane on Skin Fragility Seen in Skin Aging and With Ultraviolet Exposure
Official title: Effect of Topical Sulforaphane on Skin Fragility Seen in Skin Aging and With Ultraviolet Exposure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Aging
Keywords: aging
ultraviolet exposure
skin fragility
sulforaphane
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Subjects who are unable to provide informed consent;
2. Subject with significant medical history or current skin diseases that the investigator feels is not safe for study participation;
3. Subjects who have been treated with systemic retinoids or steroids within the past month prior to entry to the study;
4. Subjects who have been treated with topical steroids, retinoids or other topical drugs used within 2 weeks prior to entry to the study;
5. Recently treated or current skin diseases that would affect clinical evaluation and biopsy;
6. Subjects with a known allergy to broccoli.
7. Presence or suspicion of bleeding disorder or diathesis which would complicate biopsy.
8. Subjects with a history of excessive scar or keloid formation in the past 10 years.
9. Pregnant or nursing subjects (self-reported).
10. Subjects with known allergy to anesthetics used.
11. Patients with history of investigational drug use in the 30 days prior to entry into the study.

Primary outcomes:
measure: Clinical Change Score for Mottled Hyperpigmentation
timeFrame: Clinical Change Score for Mottled Hyperpigmentation , up to 1 week
Secondary outcomes:
measure: Gene Expression Changes as Assessed by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR)
timeFrame: Up to 6 months
measure: Gene Expression Changes as Assessed by Immunohistochemistry (IHC)
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Cutaneous Translational Research Program, Department of Dermatology, Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Anna Chien
role: PRINCIPAL_INVESTIGATOR
References: