Phase 1
N=30
Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen
Skin Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05736224 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement — 2.48; 2.18; 2.64; 1.14 Optical Density Units — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Sunscreen (Drug); UV Light (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement |
2.41; 2.07; 2.42; 1.03; 0.24; 0.92 | — |
| PRIMARY DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement |
2.41; 2.07; 2.42; 1.03; 0.24; 0.92 | — |
| PRIMARY Detectable DNA Strand Breaks |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of DNA Strand Breaks |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Cellular Damage |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Cellular Damage |
0; 0; 0; 0; 0; 0 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05736224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.