A Sunscreen Based on Bioadhesive Nanoparticles

• ClinicalTrials.gov Identifier: NCT02668536
• Recruitment Status: Completed
• First Posted: January 29, 2016
• Last Update Posted: March 13, 2018
• Sponsor: Yale University
• Information provided by (Responsible Party): Yale University

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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).

Contacts and Locations

Locations

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06511

Sponsors and Collaborators

Yale University

Investigators

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

More Information

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT02668536
• Other Study ID Numbers: 1512016909
• First Posted: January 29, 2016
• Last Update Posted: March 13, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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