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| ID | Type | Description | Link |
|---|---|---|---|
| 2P50CA121974-11A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The primary objective of this study is to evaluate the effects of a novel sunscreen formulation by assessing the extent of ultraviolet radiation (UVR)-induced direct and indirect cellular and DNA damage to human skin, in the presence vs absence of the sunscreen, in a population of healthy adults with fair skin (Fitzpatrick Scale type I, II or III).
Skin cancer is the most commonly diagnosed malignancy in the USA and ultraviolet radiation (UVR) exposure is the major environmental risk factor for skin cancer development. Currently available sunscreens utilize UVR filters that, while absorbing UVR energy, have been shown to induce ROS, resulting in oxidative DNA damage after UVR exposure. Organic sunscreen actives have also been shown to penetrate into the skin, raising direct toxicity, as well as irritant and photoallergic concerns. Further systemic absorption may result in additional health risks such as endocrine disruption. Novel sunscreens that more safely prevent both direct and indirect DNA damage are needed.
The study team have produced a bioadhesive nanoparticle (BNP) sunscreen designed to keep organic UVR filters from penetrating into the skin and have incorporated non-toxic natural products into this sunscreen to further safely boost UVR absorbing capacity and reduce oxidative, indirect DNA damage. This study will test the capacity of this sunscreen to prevent direct and indirect cellular and DNA damage in human skin exposed to UVR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunscreen | Experimental | Portion of skin covered by sunscreen. There are 3 different formulations of sunscreen (Formulation 1, Formulation 2, Formulation 3) |
|
| No treatment control | Other | Portion of skin not covered by sunscreen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunscreen | Drug | The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol. |
| Measure | Description | Time Frame |
|---|---|---|
| DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement | 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) | 5 minutes after UVR exposure |
| DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement | 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) | 4 hours after UVR exposure |
| Detectable DNA Strand Breaks | 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. | 5 minutes after UVR exposure |
| Number of DNA Strand Breaks | 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. | 4 hours after UVR exposure |
| Cellular Damage | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Girardi, MD, FAAD | Evans Professor of Dermatology; Director, Residency Program, Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06511 | United States |
Individual participant data that underlie the results published from this study, after deidentification (text, tables, figures, and appendices), will be made available to researchers who provide a methodologically sound proposal. Proposals should be directed to michael.girardi@yale.edu.
Beginning 3 months and ending 5 years following article publication.
Access will be given to researchers who provide a methodologically sound proposal. Proposals should be directed to michael.girardi@yale.edu. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Race/ethnicity was not collected. Subjects were screened by skin type.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement | 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) | 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. | Posted | Mean | Standard Error | Optical Density Units | 5 minutes after UVR exposure | biopsies | biopsies |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kacie Carlson, Physician Assistant | Yale University Department of Dermatology | 203 785 7432 | Kacie.carlson@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2023 | Aug 9, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 21, 2023 | Feb 13, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D013473 | Sunscreening Agents |
| D014466 | Ultraviolet Rays |
| ID | Term |
|---|---|
| D011837 | Radiation-Protective Agents |
| D020011 | Protective Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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Within subject design where participant serves as own control.
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Laboratory technicians will be blinded to treatment of samples.
| UV Light | Other | UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites. |
|
| 5 minutes after UVR exposure |
| Cellular Damage | 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. | 4 hours after UVR exposure |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Skin Type (Fitzpatrick) | Fitzpatrick Skin Type I: Pale white skin, blue/green eyes, blond/red hair; Always burns, does not tan Fitzpatrick Skin Type II: Fair skin, blue eyes; Burns easily, tans poorly Fitzpatrick Skin Type II/III: Between II and III Fitzpatrick Skin Type III: Darker white skin; Tans after initial burn | Count of Participants | Participants |
|
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. |
| OG001 | Sunscreen Formulation 2 | 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. |
| OG002 | Sunscreen Formulation 3 | 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. |
|
|
|
| Primary | DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement | 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) | 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. | Posted | Mean | Standard Error | Optical Density Units | 4 hours after UVR exposure | biopsies | biopsies |
|
|
|
| Primary | Detectable DNA Strand Breaks | 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. | 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. | Posted | Mean | Standard Error | fluorescence units | 5 minutes after UVR exposure | biopsies | biopsies |
|
|
|
| Primary | Number of DNA Strand Breaks | 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. | 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. | Posted | Mean | Standard Error | fluorescence units | 4 hours after UVR exposure | biopsies | biopsies |
|
|
|
| Primary | Cellular Damage | 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. | 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. | Posted | Mean | Standard Error | fluorescence units | 5 minutes after UVR exposure | biopsies | biopsies |
|
|
|
| Primary | Cellular Damage | 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. | 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. | Posted | Mean | Standard Error | fluorescence units | 4 hours after UVR exposure | biopsies | biopsies |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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| D020164 | Chemical Actions and Uses |
| D003879 | Dermatologic Agents |
| D045506 | Therapeutic Uses |
| D003358 | Cosmetics |
| D020313 | Specialty Uses of Chemicals |
| D008027 | Light |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D055620 | Optical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D011840 | Radiation, Nonionizing |
| D013472 | Sunlight |
| D014887 | Weather |
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
|
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| Sunscreen |
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| Sunscreen (normalized) |
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| Sunscreen |
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| Sunscreen |
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| Sunscreen |
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