A Sunscreen Based on Bioadhesive Nanoparticles

Phase 1

Completed

• Conditions: Melanoma; UV Ray Skin Damage
• Interventions: Drug: Standard Sunscreen; Device: BNP

• Registration Number: NCT02668536
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-01-29
• Study Start: 2017-07-17
• Primary Completion: 2017-08-18
• Study Completion: 2017-08-18
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-09
• Last Update Posted: 2018-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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)

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UV Filter + BNP	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.
UV Filter + BNP	Standard Sunscreen	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.
BNP only	BNP	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.
Standard	Standard Sunscreen	As the active comparator, participants will have 5 sites on their torso where they will have standard sunscreen applied.

Primary Outcome Measures

Name	Time	Method
Skin Reaction	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.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States