Skin CancerPhase 1NCT05736224

Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen

A Phase 1 study testing Sunscreen and UV Light in people with Skin Cancer, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Skin Cancer
What is being tested?: Sunscreen and UV Light
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 15 May 2023to 1 Sep 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Women of child-bearing potential must have negative urine pregnancy test
In good general health as evidenced by medical history
Fair skinned with Fitzpatrick Scale skin types I, II or III using the following Skin Type and Sunburn and Tanning History (based on the first 30-45 minutes of sun exposure after a winter season of no sun exposure):
I always burns easily; never tans (sensitive)
II always burns easily; tans minimally (sensitive)
III burns moderately; tans gradually (light brown) (normal)

Who cannot join

Individuals with active or a history of dermatological disorders-psoriasis, rosacea, eczema, vitiligo, lupus, dermatomyositis, etc
Individuals known to be subject to any abnormal responses to sunlight, such as phototoxic or photoallergic response.
Current use of medication (topical or systemic) that is known to produce abnormal sunlight responses.
History of skin cancer (such as basal cell carcinoma, squamous cell carcinoma, melanoma)
Family history of melanoma
Presence of sunburn, suntan, scars, active dermal lesions or uneven skin tone on the test site.

Show all 12Show fewer

Skin type falling under the Fitzpatrick Scale skin types IV, V or VI using the following Skin Type and Sunburn and Tanning History (based on the first 30-45 minutes of sun exposure after a winter season of no sun exposure):
IV Burns minimally; always tans well (moderate brown) (normal)
V Rarely burns; tans profusely (dark brown) (insensitive)
Use of sunscreen within the last week on the test site area (such that UV filter penetration may confound results)
Febrile illness within 48 hours.
Women with a positive urine pregnancy test

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale School of Medicine
New Haven, Connecticut, 06511

Other trials in United States

About this study

Read the detailed description

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.

Conditions: Skin Cancer
Being tested: Sunscreen, UV Light
Medical subject headings: Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SunscreenDrug
The sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.
UV LightOther
UV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.

Study groups in NCT05736224
Study group	Role	What they receive
Sunscreen	Experimental	Portion of skin covered by sunscreen. There are 3 different formulations of sunscreen (Formulation 1, Formulation 2, Formulation 3) Receives: Drug: Sunscreen; Other: UV Light
No treatment control	Other	Portion of skin not covered by sunscreen. Receives: Other: UV Light

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 hours after UVR exposure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 20231 Sep 2023

First posted21 Feb 2023
Study start15 May 2023
Primary completion1 Sep 2023
Study completion1 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Skin CancerStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Within subject design where participant serves as own control.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05736224
Sponsor's protocol ID: 2000033876
Other IDs: 2P50CA121974-11A1
Status last verified: Nov 2024
First submitted: 9 Feb 2023
Last updated: 27 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen
ClinicalTrials.gov ID: NCT05736224
Acronym / sponsor ID: 2000033876
Conditions: Skin Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 15 May 2023 (actual)
Primary completion: 1 Sep 2023 (actual)
Study completion: 1 Sep 2023 (actual)
First posted: 21 Feb 2023 (actual)
Results: Posted 27 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Within subject design where participant serves as own control.

Arm	Type	Receives
Sunscreen	Experimental	Drug: Sunscreen, Other: UV LightPortion of skin covered by sunscreen. There are 3 different formulations of sunscreen (Formulation 1, Formulation 2, Formulation 3)
No treatment control	Other	Other: UV LightPortion of skin not covered by sunscreen.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Women of child-bearing potential must have negative urine pregnancy test
In good general health as evidenced by medical history
Fair skinned with Fitzpatrick Scale skin types I, II or III using the following Skin Type and Sunburn and Tanning History (based on the first 30-45 minutes of sun exposure after a winter season of no sun exposure):

Key exclusion criteria (12 listed)

Individuals with active or a history of dermatological disorders-psoriasis, rosacea, eczema, vitiligo, lupus, dermatomyositis, etc
Individuals known to be subject to any abnormal responses to sunlight, such as phototoxic or photoallergic response.
Current use of medication (topical or systemic) that is known to produce abnormal sunlight responses.
History of skin cancer (such as basal cell carcinoma, squamous cell carcinoma, melanoma)
Family history of melanoma

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SunscreenThe sunscreen contains bioadhesive nanoparticles (BNP) encapsulating avobenzone and octocrylene plus the non-toxic natural products diosmin, ferulic acid, cytisine and trans-resveratrol.	Drug	Sunscreen
UV LightUV light to the correct sites, and the Multiport 610 solar simulator used to deliver 1 MED UVR to the appropriate subsites.	Other	No treatment control, Sunscreen

Primary outcome

DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement
Time frame: 5 minutes after UVR exposure
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)
DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement
Time frame: 4 hours after UVR exposure
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)
Detectable DNA Strand Breaks
Time frame: 5 minutes after UVR exposure
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.
Number of DNA Strand Breaks
Time frame: 4 hours after UVR exposure
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.
Cellular Damage
Time frame: 5 minutes after UVR exposure
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.
Cellular Damage
Time frame: 4 hours after UVR exposure
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.

Results and safety

Results posted to the registry on 27 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sunscreen and no Suncreen (All Participants)	30	29

Primary outcome: DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement

Time frame: 5 minutes after UVR exposure. Mean (Standard Error). Unit: Optical Density Units

Measure	Sunscreen Formulation 1 n = 8	Sunscreen Formulation 2 n = 13	Sunscreen Formulation 3 n = 8
No sunscreen	2.48 (0.15)	2.18 (0.14)	2.64 (0.09)
Sunscreen	1.14 (0.26)	0.33 (0.07)	1.24 (0.19)

Sunscreen Formulation 1: p = 0.003, t-test, 2 sided

Population analysed: 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.

Primary outcome: DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement

Time frame: 4 hours after UVR exposure. Mean (Standard Error). Unit: Optical Density Units

Measure	Sunscreen Formulation 1 n = 8	Sunscreen Formulation 2 n = 13	Sunscreen Formulation 3 n = 8
No sunscreen	2.41 (0.21)	2.07 (0.14)	2.42 (0.08)
Sunscreen	1.03 (0.26)	0.24 (0.05)	0.92 (0.23)

Primary outcome: Detectable DNA Strand Breaks

Time frame: 5 minutes after UVR exposure. Mean (Standard Error). Unit: fluorescence units

Measure	Sunscreen Formulation 1 n = 8	Sunscreen Formulation 2 n = 13	Sunscreen Formulation 3 n = 8
No sunscreen (normalized)	0 (0)	0 (0)	0 (0)
Sunscreen (normalized)	0 (0)	0 (0)	0 (0)

Primary outcome: Number of DNA Strand Breaks

Time frame: 4 hours after UVR exposure. Mean (Standard Error). Unit: fluorescence units

Measure	Sunscreen Formulation 1 n = 8	Sunscreen Formulation 2 n = 13	Sunscreen Formulation 3 n = 8
No sunscreen	0 (0)	0 (0)	0 (0)
Sunscreen	0 (0)	0 (0)	0 (0)

Adverse events

Time frame: 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sunscreen and no Suncreen (All Participants)	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Girardi, MD, FAAD principal investigator

Evans Professor of Dermatology; Director, Residency Program, Dermatology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sunscreen and UV Light in people with Skin Cancer, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement (time frame: 5 minutes after UVR exposure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05736224.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.