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(JKR-0782) Exploratory Approach to Study Keloid Formation in Human Skin

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Exploratory Approach to Study Keloid Formation in Human Skin

Principal Investigator:
James G. Krueger M.D., Ph.D.

Michael Tirgan MD
Mary Sullivan-Whalen N.P.
Patricia Gilleaudeau N.P.
Judilyn Fuentes-Duculan MD

Contact Information:
Clinical Research Support Office
1230 York Avenue
New York, NY 10065
Telephone: 1-800-RUCARES
Alt. Telephone: 800-782-2737
Enrollment Status:
Open to Enrollment

Brief Summary of Protocol:
The purpose of this research is to study a type of scar called a ‘keloid.’ A keloid, also called “proud flesh” in some cultures, is a scar that involves an exaggerated overgrowth of scar tissue where the skin was injured. Keloids are firm, rubbery, sometimes shiny, rounded lumps attached to the skin at the site of a scar; they can vary in color and size. Some keloids grow to be larger than the size of original injury and extend over areas of skin that used to be normal. Keloids are not infectious and they are not cancer; they cannot be spread to other people by touching them. They can cause pain or itching. Depending on the size and location of the keloid, it may be hidden by clothing or it may blemish a person’s appearance. Keloids may not improve in appearance over time. If the abnormal scar is located over a joint, a keloid may even limit a person’s ability to move freely.

Keloids usually form at the site of a surgical scar or injury; they can occur at the site of a piercing, a pimple or scratch. They can occur as a result of severe acne or chickenpox scars, infection at a wound site, repeated trauma to an area, stitches (sutures) that are too tight, or a when a piece of foreign material (e.g. dirt, splinter, etc) is left in a wound. Keloids can also form spontaneously, that is, without an obvious injury.

Keloids affect both sexes, occurring in young females more often than in young males, probably due to more frequent earlobe piercing among females. People of African descent and Asian descent are at much higher risk of developing keloids.

Keloids are extremely difficult to treat. Removing the keloid through surgery is one treatment option; however, it is possible that the scar from the removal surgery will also become a keloid and may even become larger than the keloid that was removed. Treatments with steroids, lasers or freezing have been used with varying degrees of success.

Detailed Description of Protocol:
If you join the research study, you will take part for up to 7 1/2 months. The research study as a whole will last about 3 years. About 20 people will take part in this research study.

The study involves:
- Skin biopsies (keloid and normal skin)
- Ultrasounds

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

- Self-identified as African or Asian decent
- With severe keloids



Children permitted to participate:

Potential Benefits.....
There will be no benefit from your participation in this research study. Instead, you and others may benefit in the future from what we learn from this study.

Compensation is provided.