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A Sunscreen Based on Bioadhesive Nanoparticles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02668536
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief 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.

Condition or disease Intervention/treatment Phase
Melanoma UV Ray Skin Damage Drug: Standard Sunscreen Device: BNP Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Assessing the Safety and Efficacy of Multifunctional Skin-adhesive Nanoparticles for UV Protection in Humans
Actual Study Start Date : July 17, 2017
Actual Primary Completion Date : August 18, 2017
Actual Study Completion Date : August 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Sun Exposure

Arm Intervention/treatment
Experimental: 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.
Drug: 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.

Device: BNP
Additional areas will be treated with empty bioadhesive nanoparticles (BNPs).

Sham Comparator: 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.
Device: BNP
Additional areas will be treated with empty bioadhesive nanoparticles (BNPs).

Active Comparator: Standard
As the active comparator, participants will have 5 sites on their torso where they will have standard sunscreen applied.
Drug: 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.

No Intervention: Control
Participants will have 5 sites on their torso where no agent will be applied.



Primary Outcome Measures :
  1. Skin Reaction [ Time Frame: 1 week ]
    Skin reaction will be assessed by exam. The exam will look for evidence of irritation, inflammation, follicular occlusion. In addition, patients will report any skin reaction at site of application over one week. Severity of the skin reactions will be assessed in the following manner: severe reactions will include evidence of edema or blister formation, follicular pustules and/or marked erythema and pruritus.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668536


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Michael Girardi, MD, FAAD Yale University
Principal Investigator: Mark Saltzman, PhD Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02668536    
Other Study ID Numbers: 1512016909
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
sunscreen
melanoma
improved protection from uv rays
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Melanoma
Nevi and Melanomas
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents