Clinical trial · Interventional
Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen
NCT05736224CI-TRIAL-00083060completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sunscreen | Drug | — | UNRESOLVED |
| UV Light | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sunscreen
- description
- Portion of skin covered by sunscreen. There are 3 different formulations of sunscreen (Formulation 1, Formulation 2, Formulation 3)
- interventionNames
- Drug: Sunscreen
- Other: UV Light
- type
- OTHER
- label
- No treatment control
- description
- Portion of skin not covered by sunscreen.
- interventionNames
- Other: UV Light
Primary outcomes (6)
- measure
- DNA Damage Level by Cyclobutane Pyrimidine Dimer (CPD) Measurement
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.