Trial Outcomes & Findings for Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen (NCT NCT05736224)
NCT ID: NCT05736224
Last Updated: 2024-11-27
Results Overview
Ultraviolet radiation (UVR) exposure are indicative of direct DNA damage. DNA will be prepared and assayed by ELISA for quantification of CPDs. CPDs measured in samples obtained immediately after UVR exposure are indicative of direct DNA damage. DNA from skin biopsies was used to quantify the level of DNA damage, represented by CPD levels detected by enzyme-linked immunosorbent assay (ELISA)
COMPLETED
PHASE1
30 participants
5 minutes after UVR exposure
2024-11-27
Participant Flow
Participant milestones
| Measure |
Sunscreen and no Suncreen (All Participants)
All participants will have biopsies from a portion of skin with sunscreen applied and a portion of skin without sunscreen applied
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
Formulation 1
|
8
|
|
Overall Study
Formulation 2
|
14
|
|
Overall Study
Formulation 3
|
8
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Sunscreen and no Suncreen (All Participants)
All participants will have biopsies from a portion of skin with sunscreen applied and a portion of skin without sunscreen applied
|
|---|---|
|
Overall Study
Excluded from analysis because processed biopsy sample was inadequate for analysis
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Sunscreen and no Suncreen (All Participants)
n=30 Participants
All participants will have biopsies from a portion of skin with sunscreen applied and a portion of skin without sunscreen applied
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=30 Participants
|
|
Skin Type (Fitzpatrick)
Fitzpatrick Type I
|
1 Participants
n=30 Participants
|
|
Skin Type (Fitzpatrick)
Fitzpatrick Type II
|
20 Participants
n=30 Participants
|
|
Skin Type (Fitzpatrick)
Fitzpatrick Type II/III
|
2 Participants
n=30 Participants
|
|
Skin Type (Fitzpatrick)
Fitzpatrick Type III
|
7 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 5 minutes after UVR exposurePopulation: Test Sites were delineated on the subjects upper inner arm, then either No sunscreen was applied, or the Test Sunscreen was applied 1 time at the FDA prescribed level (2 mg/cm2) and dried for 15 minutes before UVR exposure. The test sites were biopsied 5 minutes and 4 hours after UVR exposure. Two biopsies (one with sunscreen and one without) were taken per participant.
Ultraviolet radiation (UVR) exposure are indicative of direct DNA damage. DNA will be prepared and assayed by ELISA for quantification of CPDs. CPDs measured in samples obtained immediately after UVR exposure are indicative of direct DNA damage. DNA from skin biopsies was used to quantify the level of DNA damage, represented by CPD levels detected by enzyme-linked immunosorbent assay (ELISA)
Outcome measures
| Measure |
Sunscreen Formulation 1
n=16 biopsies
Two biopsies were taken per participant: one from portion of skin covered by sunscreen and one where no sunscreen was applied.
Sunscreen: The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV Light: UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
|
Sunscreen Formulation 2
n=26 biopsies
Two biopsies were taken per participant: one from portion of skin covered by sunscreen and one where no sunscreen was applied.
Sunscreen: The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV Light: UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
|
Sunscreen Formulation 3
n=16 biopsies
Two biopsies were taken per participant: one from portion of skin covered by sunscreen and one where no sunscreen was applied.
Sunscreen: The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV Light: UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
|
|---|---|---|---|
|
DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement
No sunscreen
|
2.48 Optical Density Units
Standard Error 0.15
|
2.18 Optical Density Units
Standard Error 0.14
|
2.64 Optical Density Units
Standard Error 0.09
|
|
DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement
Sunscreen
|
1.14 Optical Density Units
Standard Error 0.26
|
0.33 Optical Density Units
Standard Error 0.07
|
1.24 Optical Density Units
Standard Error 0.19
|
PRIMARY outcome
Timeframe: 4 hours after UVR exposurePopulation: Test Sites were delineated on the subjects upper inner arm, then either No sunscreen was applied, or the Test Sunscreen was applied 1 time at the FDA prescribed level (2 mg/cm2) and dried for 15 minutes before UVR exposure. The test sites were biopsied 5 minutes and 4 hours after UVR exposure. Two biopsies (one with sunscreen and one without) were taken per participant.
Ultraviolet radiation (UVR) exposure are indicative of direct DNA damage. DNA will be prepared and assayed by ELISA for quantification of CPDs. CPDs measured in samples obtained immediately after UVR exposure are indicative of direct DNA damage. DNA from skin biopsies was used to quantify the level of DNA damage, represented by CPD levels detected by enzyme-linked immunosorbent assay (ELISA)
Outcome measures
| Measure |
Sunscreen Formulation 1
n=16 biopsies
Two biopsies were taken per participant: one from portion of skin covered by sunscreen and one where no sunscreen was applied.
Sunscreen: The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV Light: UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
|
Sunscreen Formulation 2
n=26 biopsies
Two biopsies were taken per participant: one from portion of skin covered by sunscreen and one where no sunscreen was applied.
Sunscreen: The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV Light: UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
|
Sunscreen Formulation 3
n=16 biopsies
Two biopsies were taken per participant: one from portion of skin covered by sunscreen and one where no sunscreen was applied.
Sunscreen: The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV Light: UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
|
|---|---|---|---|
|
DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement
Sunscreen
|
1.03 Optical Density Units
Standard Error 0.26
|
0.24 Optical Density Units
Standard Error 0.05
|
0.92 Optical Density Units
Standard Error 0.23
|
|
DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement
No sunscreen
|
2.41 Optical Density Units
Standard Error 0.21
|
2.07 Optical Density Units
Standard Error 0.14
|
2.42 Optical Density Units
Standard Error 0.08
|
PRIMARY outcome
Timeframe: 5 minutes after UVR exposurePopulation: Test Sites were delineated on the subjects upper inner arm, then either No sunscreen was applied, or the Test Sunscreen was applied 1 time at the FDA prescribed level (2 mg/cm2) and dried for 15 minutes before UVR exposure. The test sites were biopsied 5 minutes and 4 hours after UVR exposure. Two biopsies (one with sunscreen and one without) were taken per participant.
Formalin fixed paraffin embedded skin stained with anti-gH2AX to identify keratinocytes with DNA strand breaks. Indirect, oxidative DNA damage may result in DNA strand breaks that can be visualized by microscopic analysis after staining for gH2AX, which builds up within cells with DNA strand break.
Outcome measures
| Measure |
Sunscreen Formulation 1
n=16 biopsies
Two biopsies were taken per participant: one from portion of skin covered by sunscreen and one where no sunscreen was applied.
Sunscreen: The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV Light: UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
|
Sunscreen Formulation 2
n=26 biopsies
Two biopsies were taken per participant: one from portion of skin covered by sunscreen and one where no sunscreen was applied.
Sunscreen: The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV Light: UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
|
Sunscreen Formulation 3
n=16 biopsies
Two biopsies were taken per participant: one from portion of skin covered by sunscreen and one where no sunscreen was applied.
Sunscreen: The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV Light: UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
|
|---|---|---|---|
|
Detectable DNA Strand Breaks
No sunscreen (normalized)
|
0 fluorescence units
Standard Error 0
|
0 fluorescence units
Standard Error 0
|
0 fluorescence units
Standard Error 0
|
|
Detectable DNA Strand Breaks
Sunscreen (normalized)
|
0 fluorescence units
Standard Error 0
|
0 fluorescence units
Standard Error 0
|
0 fluorescence units
Standard Error 0
|
PRIMARY outcome
Timeframe: 4 hours after UVR exposurePopulation: Test Sites were delineated on the subjects upper inner arm, then either No sunscreen was applied, or the Test Sunscreen was applied 1 time at the FDA prescribed level (2 mg/cm2) and dried for 15 minutes before UVR exposure. The test sites were biopsied 5 minutes and 4 hours after UVR exposure. Two biopsies (one with sunscreen and one without) were taken per participant.
Formalin fixed paraffin embedded skin stained with anti-gH2AX to identify keratinocytes with DNA strand breaks. Indirect, oxidative DNA damage may result in DNA strand breaks that can be visualized by microscopic analysis after staining for gH2AX, which builds up within cells with DNA strand break.
Outcome measures
| Measure |
Sunscreen Formulation 1
n=16 biopsies
Two biopsies were taken per participant: one from portion of skin covered by sunscreen and one where no sunscreen was applied.
Sunscreen: The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV Light: UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
|
Sunscreen Formulation 2
n=26 biopsies
Two biopsies were taken per participant: one from portion of skin covered by sunscreen and one where no sunscreen was applied.
Sunscreen: The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV Light: UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
|
Sunscreen Formulation 3
n=16 biopsies
Two biopsies were taken per participant: one from portion of skin covered by sunscreen and one where no sunscreen was applied.
Sunscreen: The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV Light: UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
|
|---|---|---|---|
|
Number of DNA Strand Breaks
No sunscreen
|
0 fluorescence units
Standard Error 0
|
0 fluorescence units
Standard Error 0
|
0 fluorescence units
Standard Error 0
|
|
Number of DNA Strand Breaks
Sunscreen
|
0 fluorescence units
Standard Error 0
|
0 fluorescence units
Standard Error 0
|
0 fluorescence units
Standard Error 0
|
PRIMARY outcome
Timeframe: 5 minutes after UVR exposurePopulation: Test Sites were delineated on the subjects upper inner arm, then either No sunscreen was applied, or the Test Sunscreen was applied 1 time at the FDA prescribed level (2 mg/cm2) and dried for 15 minutes before UVR exposure. The test sites were biopsied 5 minutes and 4 hours after UVR exposure. Two biopsies (one with sunscreen and one without) were taken per participant.
Formalin fixed paraffin embedded skin stained with anti-3-nitrotyrosine to identify cellular damage. ROS and high energy triplet state species can result in nitration of tyrosine residues of cellular proteins. This type of damage can be visualized by microscopic visualization of 3-nitrotyrosine.
Outcome measures
| Measure |
Sunscreen Formulation 1
n=16 biopsies
Two biopsies were taken per participant: one from portion of skin covered by sunscreen and one where no sunscreen was applied.
Sunscreen: The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV Light: UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
|
Sunscreen Formulation 2
n=26 biopsies
Two biopsies were taken per participant: one from portion of skin covered by sunscreen and one where no sunscreen was applied.
Sunscreen: The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV Light: UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
|
Sunscreen Formulation 3
n=16 biopsies
Two biopsies were taken per participant: one from portion of skin covered by sunscreen and one where no sunscreen was applied.
Sunscreen: The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV Light: UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
|
|---|---|---|---|
|
Cellular Damage
No sunscreen
|
0 fluorescence units
Standard Error 0
|
0 fluorescence units
Standard Error 0
|
0 fluorescence units
Standard Error 0
|
|
Cellular Damage
Sunscreen
|
0 fluorescence units
Standard Error 0
|
0 fluorescence units
Standard Error 0
|
0 fluorescence units
Standard Error 0
|
PRIMARY outcome
Timeframe: 4 hours after UVR exposurePopulation: Test Sites were delineated on the subjects upper inner arm, then either No sunscreen was applied, or the Test Sunscreen was applied 1 time at the FDA prescribed level (2 mg/cm2) and dried for 15 minutes before UVR exposure. The test sites were biopsied 5 minutes and 4 hours after UVR exposure. Two biopsies (one with sunscreen and one without) were taken per participant.
Formalin fixed paraffin embedded skin stained with anti-3-nitrotyrosine to identify cellular damage. ROS and high energy triplet state species can result in nitration of tyrosine residues of cellular proteins. This type of damage can be visualized by microscopic visualization of 3-nitrotyrosine.
Outcome measures
| Measure |
Sunscreen Formulation 1
n=16 biopsies
Two biopsies were taken per participant: one from portion of skin covered by sunscreen and one where no sunscreen was applied.
Sunscreen: The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV Light: UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
|
Sunscreen Formulation 2
n=26 biopsies
Two biopsies were taken per participant: one from portion of skin covered by sunscreen and one where no sunscreen was applied.
Sunscreen: The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV Light: UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
|
Sunscreen Formulation 3
n=16 biopsies
Two biopsies were taken per participant: one from portion of skin covered by sunscreen and one where no sunscreen was applied.
Sunscreen: The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV Light: UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.
|
|---|---|---|---|
|
Cellular Damage
No sunscreen
|
0 fluorescence units
Standard Error 0
|
0 fluorescence units
Standard Error 0
|
0 fluorescence units
Standard Error 0
|
|
Cellular Damage
Sunscreen
|
0 fluorescence units
Standard Error 0
|
0 fluorescence units
Standard Error 0
|
0 fluorescence units
Standard Error 0
|
Adverse Events
Sunscreen and no Suncreen (All Participants)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kacie Carlson, Physician Assistant
Yale University Department of Dermatology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place