Colorant Based Markers for Dermatological Use

Primary Point of Contact

Name: Melanie Adams, MD, FAAD

Organization: Melanie A. Adams, MD, PA

Email Address: madams@adamsdermatology.com

The Problem – Please define the dermatologic clinical problem worth solving, the current solutions,

and the strengths and weaknesses of the current solutions.

The American Academy of Dermatology has recognized wrong site surgery as a "major patient safety

issue“, accounting for ~14% of malpractice claims for Mohs surgeons who often work in outpatient

ambulatory care centers. Wrong site surgery was the second most common reported event from 1995

to 2005 across all surgical sub-specialties. Current solutions include identification of the operative site

by the patient or escort which may be inaccurate. Photos may lack clear anatomical markers, while

wristbands and surgical markers may be misplaced. The incidence of skin cancer is epidemic. A method

of communication between the referring physician, operating physician, and dermatopathologist is

needed.

Your solution - Describe how your solution is different and why it is valuable.

A sterile, handheld, single use, disposable, minimally invasive medical device which would be used by

physicians to identify the operative site. A lasting visual impression would be identified by the operative

physician thus allowing for physician to physician communication. The dermatopathologist would

identify the presence of this material in the operative report therefore confirming the correct anatomic

site. The long term injectable material would be removed completely by the operative physician.

Methods and Results.

The method involves the use of selected FD&C approved colorants with ability to remain perceptible

after multiple washings of the skin, especially the face. These markers enable the application of a

temporary color to skin which wears off as the outer layer of skin sheds. Our preliminary experiments

involved the characterization of 6 certifiable FD&C colorants and 8 natural dyes as markers, using pig

skin as a human skin model, and a silastic membrane as artificial skin. Results from both models indicate

that dye uptake on skin surfaces occurs but most of the dyes do not penetrate to the degree

characteristic of entering the bloodstream. This has enabled our team to select 3 colorants from 14

candidates to advance to in vivo studies

Product profile and development plan - Describe the product or service (i.e. some information of what

it is) and what stage it is in (e.g. concept, preclinical, prototyped, closed beta, etc. as applicable). Also

please include the next major milestone (and costs to that milestone) in the product’s development.

In Phase I, results obtained from flow through diffusion tests showed that 3 natural colorants have

potential application as a marker for the skin.

We now plan to conduct studies pertaining to: 1) intradermal placement and testing of colorants to pig

skin in laboratory conditions, 2) intradermal placement and topical testing of colorants on live pigs, 3)

changes to marker sites on pigs over a 6 month period for visibility, 4) colorant fastness properties on

intradermal placement of colorants on live pigs, 5) testing injection sites over a 6 month period for

visibility and assessing colorants fastness properties, 6) Selection of the most suitable marker(s) for

clinical studies. An STTR application has been submitted for continued research studies. Dr. Clay

Cockerell has agreed to collaborate with us on skin sample analyses.

Value of your solution – What is your rough estimate of the yearly market revenue potential (and

what are some for the basic assumptions underlying that estimate, e.g. this product could be used by

X individuals per year, and so forth)?

The method involves the use of selected FD&C approved colorants with ability to remain perceptible

after multiple washings of the skin, especially the face. These markers enable the application of a

temporary color to skin which wears off as the outer layer of skin sheds. Our preliminary experiments

involved the characterization of 6 certifiable FD&C colorants and 8 natural dyes as markers, using pig

skin as a human skin model, and a silastic membrane as artificial skin. Results from both models indicate

that dye uptake on skin surfaces occurs but most of the dyes do not penetrate to the degree

characteristic of entering the bloodstream. This has enabled our team to select 3 colorants from 14

candidates to advance to in vivo studies