A Sunscreen Based on Bioadhesive Nanoparticles

• Status: Completed
• Trial end date: 2017-08-18
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Treatments: Sunscreening Agents

Criteria

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).