Clinical trial · Interventional
A Sunscreen Based on Bioadhesive Nanoparticles
Assessing the Safety and Efficacy of Multifunctional Skin-adhesive Nanoparticles for UV Protection in Humans
NCT02668536CI-TRIAL-00032044completedPhase 1ClinicalTrials.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 initial focus of the study will be on safety, sun protection factor (SPF) characterization, and substantivity (duration of protection) studies. The primary outcome of the study will be to measure the sun protection factor (SPF) of a bioadhesive nanoparticles (BNP) formulation in 20-25 healthy volunteers with fair skin.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| UV Ray Skin Damage | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BNP | Device | — | UNRESOLVED |
| Standard Sunscreen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- UV Filter + BNP
- description
- A UV filtering agent and bioadhesive nanoparticles (BNPs) will comprise the experimental condition in this study. Participants will have 5 sites on their torso where they will have these placed.
- interventionNames
- Drug: Standard Sunscreen
- Device: BNP
- type
- SHAM_COMPARATOR
- label
- BNP only
- description
- A placebo bioadhesive nanoparticles (BNPs) (strips with no UV filtering) will comprise the sham comparison in this study. Participants will have 5 sites on their torso where they will have these placed.
- interventionNames
- Device: BNP
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must be in good health with minimal skin irregularities, as evaluated by a physical examination. * The physical examination shall determine the presence of sunburn, suntan, scars, active dermal lesions, and uneven skin tones on the areas of the back to be tested. The presence of nevi, blemishes, or moles will be acceptable if in the physician's judgment they will not interfere with the study results. Excess hair on the back is acceptable if the hair is clipped or shaved. * Subjects must fall into one of the following 3 Fitzpatrick Skin Scale categories: 1. Always burns easily; never tans (sensitive) 2. Always burns easily; tans minimally (sensitive) 3. Burns moderately; tans gradually (light brown) (normal) Exclusion Criteria: * Volunteers cannot have a history of skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or melanoma). * Volunteers cannot have a history of skin disease (such as psoriasis, exema, or vitiligo).
References
Publications (0)
Data not yet available
No reference posted for this study.