Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen

NCT05736224 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 20000338762P50CA121974-11A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 (Fitzpatrick Scale type I, II or III).

Conditions

Skin Cancer

Outcome Measures

Primary Outcomes (6)

• 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.

  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

Study Arms (2)

Sunscreen

EXPERIMENTAL

Portion of skin covered by sunscreen. There are 3 different formulations of sunscreen (Formulation 1, Formulation 2, Formulation 3)

Drug: Sunscreen; Other: UV Light

No treatment control

OTHER

Portion of skin not covered by sunscreen.

Other: UV Light

Interventions

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.

Sunscreen

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.

No treatment control; Sunscreen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Sunscreening Agents; Ultraviolet Rays

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Ionizing; Radiation, Nonionizing; Sunlight; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Results Point of Contact

• Title: Kacie Carlson, Physician Assistant
• Organization: Yale University Department of Dermatology

Kacie.carlson@yale.edu

203 785 7432

Study Officials

• Michael Girardi, MD, FAAD

  Evans Professor of Dermatology; Director, Residency Program, Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory technicians will be blinded to treatment of samples.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within subject design where participant serves as own control.

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: May 15, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: November 27, 2024
• Results First Posted: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: 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.

Locations

US (1)