A Sunscreen Based on Bioadhesive Nanoparticles

The purpose of this study will be to evaluate the duration of protection and efficacy of a
novel bioadhesive nanoparticle sunscreen in 20-25 human volunteers.This technology makes
sunscreens safer and longer-lasting by encapsulating UV sunscreen active agents in non-toxic
nanoparticles. Strong preclinical data exists demonstrating the potential for improved
safety, long-duration of retention, and increased effectiveness of this product.

This innovative solution focuses on preventing damage caused by UV exposure through the use
of a nanoparticle delivery vehicle. The bioadhesive feature of this technology enables longer
protection. In addition, encapsulation of the UV filter in a bioadhesive nanoparticle (BNP)
improves filter photo-stability, delays filter photo-degradation, and prevents reactive
oxygen species (ROS) escape, thereby reducing the risk of cell damage and epidermal toxicity
from UV filters.

Furthermore, the bioadhesive feature of our technology eliminates penetration into deeper
skin layers or into the blood, minimizing the potential side-effects of UV filters. It is
believed that the translation of this technology will provide a longer-lasting, safer, more
protective UV sunscreen.

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).