Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2017-07-17
2017-08-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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UV Filter + BNP
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.
Standard Sunscreen
Areas will be treated with a standard preparation, consisting of padimate O (7%) and oxybenzone (3%) will be used as the control sunscreen.
BNP
Additional areas will be treated with empty bioadhesive nanoparticles (BNPs).
BNP only
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.
BNP
Additional areas will be treated with empty bioadhesive nanoparticles (BNPs).
Standard
As the active comparator, participants will have 5 sites on their torso where they will have standard sunscreen applied.
Standard Sunscreen
Areas will be treated with a standard preparation, consisting of padimate O (7%) and oxybenzone (3%) will be used as the control sunscreen.
Control
Participants will have 5 sites on their torso where no agent will be applied.
No interventions assigned to this group
Interventions
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Standard Sunscreen
Areas will be treated with a standard preparation, consisting of padimate O (7%) and oxybenzone (3%) will be used as the control sunscreen.
BNP
Additional areas will be treated with empty bioadhesive nanoparticles (BNPs).
Eligibility Criteria
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Inclusion Criteria
* 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 disease (such as psoriasis, exema, or vitiligo).
18 Years
ALL
Yes
Sponsors
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Yale University
OTHER
Responsible Party
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Principal Investigators
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Michael Girardi, MD, FAAD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Mark Saltzman, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University
New Haven, Connecticut, United States
Countries
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Other Identifiers
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1512016909
Identifier Type: -
Identifier Source: org_study_id
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