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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
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Aging
Interventions Drug: Sulforaphane
Radiation: Narrow-band Ultraviolet B exposure
Procedure: 4 mm skin punch biopsy
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A: No UV Exposure - Sulforaphane Group A: No UV Exposure - Placebo Group A: No UV Exposure - No Treatment Control Group B With UV Exposure - Sulforaphane Group B With UV Exposure - Placebo
Hide Arm/Group Description

One photoexposed site will be identified. 500nmol Sulforaphane in jojoba oil will be applied topically to site every night for up to 7 consecutive nights. Biopsy will be obtained after this intervention on standard photoexposed site.

4 mm skin punch 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 five 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.

One photoexposed site will be identified. Jojoba oil will be applied topically to site every night for up to 7 consecutive nights. Biopsy will be obtained after this intervention on standard photoexposed site.

4 mm skin punch 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 five 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.

One photoprotected site and two photoexposed sites will be identified. No treatment will be administered at this site. A 4mm punch biopsy will be obtained from this site as a control.

4 mm skin punch 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 five 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.

One photoprotected site will be identified. 500nmol sulforaphane in jojoba oil will be applied topically to the site for up to 7 consecutive nights. Site will be exposed to UV. Biopsy of site will be obtained prior to, and 24 hours after UV exposure. Narrow-band Ultraviolet B (UVB) exposure: The investigators will use a Lumera UVB light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320nm). 4 mm skin punch 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 typically heals well without complications. One photoprotected sites will be identified. Jojoba Oil will be applied topically to a single selected site for up to 7 consecutive nights. Site will be exposed to UV. Biopsies of site will be obtained prior to, and 24 hours after UV exposure. Narrow-band Ultraviolet B (UVB) exposure: The investigators will use a Lumera UVB light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320nm). 4 mm skin punch 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.
Period Title: Overall Study
Number of participants Number of units (Skin spot) Number of participants Number of units (Skin spot) Number of participants Number of units (Skin spot) Number of participants Number of units (Skin spot) Number of participants Number of units (Skin spot)
Started 9 9 9 9 9 27 0 [1] 0 0 0
Completed 8 8 8 8 8 24 0 0 0 0
Not Completed 1 1 1 1 1 3 0 0 0 0
Reason Not Completed
Lost to Follow-up             1                         1                         1                         0                         0            
[1]
Group B was not done
Arm/Group Title Group A: No UV Exposure Group B With UV Exposure Total
Hide Arm/Group Description

Two photoprotected sites will be identified. 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.

4 mm skin punch 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.

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.

Narrow-band Ultraviolet B exposure: The investigators will use a Lumera UVB light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320 nm).

4 mm skin punch 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

Total of all reporting groups
Overall Number of Baseline Participants 9 0 9
Hide Baseline Analysis Population Description
We did not enroll any participants in Group B.
Age, Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants 0 participants 9 participants
57
(52 to 77)
57
(52 to 77)
[1]
Measure Analysis Population Description: the same
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 0 participants 9 participants
Female
7
  77.8%
7
  77.8%
Male
2
  22.2%
2
  22.2%
[1]
Measure Analysis Population Description: the same
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Caucasian Number Analyzed 9 participants 0 participants 9 participants
9
 100.0%
9
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 9 participants 0 participants 9 participants
9
 100.0%
9
 100.0%
1.Primary Outcome
Title Clinical Change Score for Mottled Hyperpigmentation
Hide Description 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.
Time Frame Clinical Change Score for Mottled Hyperpigmentation , up to 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group A: No UV Exposure - Sulforaphane Group A: No UV Exposure - Placebo Group A: No UV Exposure - No Treatment Control Group B With UV Exposure - Sulforaphane Group B With UV Exposure - Placebo
Hide Arm/Group Description:

One photoexposed site will be identified. 500nmol Sulforaphane in jojoba oil will be applied topically to site every night for up to 7 consecutive nights. Biopsy will be obtained after this intervention on standard photoexposed site.

4 mm skin punch 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 five 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.

One photoexposed site will be identified. Jojoba oil will be applied topically to site every night for up to 7 consecutive nights. Biopsy will be obtained after this intervention on standard photoexposed site.

4 mm skin punch 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 five 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.

One photoprotected site and two photoexposed sites will be identified. No treatment will be administered at this site. A 4mm punch biopsy will be obtained from this site as a control.

4 mm skin punch 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 five 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.

One photoprotected site will be identified. 500nmol sulforaphane in jojoba oil will be applied topically to the site for up to 7 consecutive nights. Site will be exposed to UV. Biopsy of site will be obtained prior to, and 24 hours after UV exposure. Narrow-band Ultraviolet B (UVB) exposure: The investigators will use a Lumera UVB light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320nm). 4 mm skin punch 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 typically heals well without complications.
One photoprotected sites will be identified. Jojoba Oil will be applied topically to a single selected site for up to 7 consecutive nights. Site will be exposed to UV. Biopsies of site will be obtained prior to, and 24 hours after UV exposure. Narrow-band Ultraviolet B (UVB) exposure: The investigators will use a Lumera UVB light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320nm). 4 mm skin punch 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.
Overall Number of Participants Analyzed 8 8 9 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Skin spots
8 8 24 0 0
Mean (Standard Error)
Unit of Measure: score on a scale
2.8  (0.4) .94  (.2) 0  (0)
2.Secondary Outcome
Title Gene Expression Changes as Assessed by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Hide Description 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.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was not collected.
Arm/Group Title Group A: No UV Exposure Group B With UV Exposure
Hide Arm/Group Description:

Two photoprotected sites will be identified. 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.

4 mm skin punch 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.

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.

Narrow-band Ultraviolet B exposure: The investigators will use a Lumera UVB light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320 nm).

4 mm skin punch 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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Gene Expression Changes as Assessed by Immunohistochemistry (IHC)
Hide Description 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.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was not collected.
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

Sulforaphane: Isothiocyanate sulforaphane (SF), derived from broccoli sprouts, has been known to induce an antioxidant response through the Keap1-Nrf2-antioxidant response element pathway.

4 mm skin punch 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.

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.

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 exposure: 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 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 c

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Four weeks
Adverse Event Reporting Description We did not enroll any participants in group B.
 
Arm/Group Title Group A: No UV Exposure Group B With UV Exposure
Hide Arm/Group Description

Two photoprotected sites will be identified. 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.

4 mm skin punch 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.

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.

Narrow-band Ultraviolet B exposure: The investigators will use a Lumera UVB light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320 nm).

4 mm skin punch 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

All-Cause Mortality
Group A: No UV Exposure Group B With UV Exposure
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/0 
Hide Serious Adverse Events
Group A: No UV Exposure Group B With UV Exposure
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A: No UV Exposure Group B With UV Exposure
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Anna Chien
Organization: Johns Hopkins University
Phone: 410-502-7546
EMail: CTReP@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03126539    
Other Study ID Numbers: IRB00105668
First Submitted: April 7, 2017
First Posted: April 24, 2017
Results First Submitted: November 22, 2019
Results First Posted: February 25, 2020
Last Update Posted: February 25, 2020