A Sunscreen Based on Bioadhesive Nanoparticles

Completed · Phase 1

Conditions studied: Melanoma, UV Ray Skin Damage

In brief

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.

Key facts

Study ID

NCT02668536

Run by

Yale University

People needed

13

Starts

2017-07-17

Expected to finish

2017-08-18

Last updated by the study team

2018-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• Always burns easily; never tans (sensitive)
• Always burns easily; tans minimally (sensitive)
• Burns moderately; tans gradually (light brown) (normal)

You may not qualify if…

• 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).

Where it is running

• Yale University — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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