A Sunscreen Based on Bioadhesive Nanoparticles

March 9, 2018 updated by: Yale University

Assessing the Safety and Efficacy of Multifunctional Skin-adhesive Nanoparticles for UV Protection in Humans

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Michael Girardi, MD, FAAD, Yale University
  • Principal Investigator: Mark Saltzman, PhD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2017

Primary Completion (Actual)

August 18, 2017

Study Completion (Actual)

August 18, 2017

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1512016909

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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