Trial Outcomes & Findings for Effect of Topical Sulforaphane on Skin Fragility Seen in Skin Aging and With Ultraviolet Exposure (NCT NCT03126539)
NCT ID: NCT03126539
Last Updated: 2023-06-29
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Clinical Change Score for Mottled Hyperpigmentation , up to 1 week
Results posted on
2023-06-29
Participant Flow
Unit of analysis: Skin spot
Participant milestones
| Measure |
Group A: No UV Exposure - Sulforaphane
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.
|
Group A: No UV Exposure - Placebo
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.
|
Group A: No UV Exposure - No Treatment Control
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.
|
Group B With UV Exposure - Sulforaphane
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.
|
Group B With UV Exposure - Placebo
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 Study
STARTED
|
9 9
|
9 9
|
9 27
|
0 0
|
0 0
|
|
Overall Study
COMPLETED
|
8 8
|
8 8
|
8 24
|
0 0
|
0 0
|
|
Overall Study
NOT COMPLETED
|
1 1
|
1 1
|
1 3
|
0 0
|
0 0
|
Reasons for withdrawal
| Measure |
Group A: No UV Exposure - Sulforaphane
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.
|
Group A: No UV Exposure - Placebo
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.
|
Group A: No UV Exposure - No Treatment Control
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.
|
Group B With UV Exposure - Sulforaphane
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.
|
Group B With UV Exposure - Placebo
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 Study
Lost to Follow-up
|
1
|
1
|
1
|
0
|
0
|
Baseline Characteristics
the same
Baseline characteristics by cohort
| Measure |
Group A: No UV Exposure
n=9 Participants
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.
|
Group B With UV Exposure
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
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants • the same
|
—
|
57 years
n=5 Participants • the same
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants • the same
|
—
|
7 Participants
n=5 Participants • the same
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants • the same
|
—
|
2 Participants
n=5 Participants • the same
|
|
Race/Ethnicity, Customized
Caucasian
|
9 Participants
n=5 Participants
|
—
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
—
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Clinical Change Score for Mottled Hyperpigmentation , up to 1 weekPopulation: 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.
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.
Outcome measures
| Measure |
Group A: No UV Exposure - Sulforaphane
n=8 Skin spots
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.
|
Group A: No UV Exposure - Placebo
n=8 Skin spots
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.
|
Group A: No UV Exposure - No Treatment Control
n=24 Skin spots
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.
|
Group B With UV Exposure - Sulforaphane
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.
|
Group B With UV Exposure - Placebo
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.
|
|---|---|---|---|---|---|
|
Clinical Change Score for Mottled Hyperpigmentation
|
2.8 score on a scale
Standard Error 0.4
|
.94 score on a scale
Standard Error .2
|
0 score on a scale
Standard Error 0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Data for this outcome measure was not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Data for this outcome measure was not collected.
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.
Outcome measures
Outcome data not reported
Adverse Events
Group A: No UV Exposure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B With UV Exposure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place