NCT02668536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
1.5 years until next milestone

Study Start

First participant enrolled

July 17, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2017

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

1 month

First QC Date

January 26, 2016

Last Update Submit

March 9, 2018

Conditions

MelanomaUV Ray Skin Damage

Keywords

sunscreenmelanomaimproved protection from uv rays

Outcome Measures

Primary Outcomes (1)

  • Skin Reaction

    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

Study Arms (4)

UV Filter + BNP

EXPERIMENTAL

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 SunscreenDevice: BNP

BNP only

SHAM COMPARATOR

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

Standard

ACTIVE COMPARATOR

As the active comparator, participants will have 5 sites on their torso where they will have standard sunscreen applied.

Drug: Standard Sunscreen

Control

NO INTERVENTION

Participants will have 5 sites on their torso where no agent will be applied.

Interventions

Standard SunscreenDRUG

Areas will be treated with a standard preparation, consisting of padimate O (7%) and oxybenzone (3%) will be used as the control sunscreen.

StandardUV Filter + BNP
BNPDEVICE

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

BNP onlyUV Filter + BNP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Always burns easily; never tans (sensitive)
  • Always burns easily; tans minimally (sensitive)
  • Burns moderately; tans gradually (light brown) (normal)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michael Girardi, MD, FAAD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Mark Saltzman, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2016

First Posted

January 29, 2016

Study Start

July 17, 2017

Primary Completion

August 18, 2017

Study Completion

August 18, 2017

Last Updated

March 13, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)