Clinical Trials

Major advances in medicine have been made by extending the biological discoveries in the laboratories to clinical settings and treating patients. This is the basic methodology that KRF is planning to use in finding better treatments for keloid disorder. This very important methodology will bring us unprecedented opportunities to change the practice of medicine, the obstacles facing us in treatment of patients with keloid. Medical research is a continuum that spans diverse realms of laboratory research and several kinds of clinical research. Clinical research is a crucial element and an essential step in this endeavor.

What is clinical research?

Clinical research refers to research conducted with human beings, including studies of specimens collected from patients who have keloid. It encompasses some laboratory research on the mechanisms of human disease, translational research (in which laboratory and clinical activities are closely aligned), clinical trials of preventive and therapeutic strategies, epidemiology, behavioral research, and health services and outcomes research.

Because it covers so many topics, clinical research the skills and expertise of many kinds of investigators, including physician scientists, public health, nursing and various laboratory sciences, are needed. Other professionals such as computer programmers, bio-engineers, and technicians are also essential for clinical research. Clinical research is conducted at a variety of sites and by a variety of entities. Academic Health Centers (AHCs), government labs and clinics, community hospitals, State health organizations, and managed care and pharmaceutical industry sites are all active participants in the Nation's clinical research enterprise. The success of clinical research depends on funding from both Federal and private sector sources. Much of the research funds are funneled to cancer research, and research in infectious diseases like HIV. With proper funding, KRF will be able to foster much needed research in keloid and pave the way for better understanding this disease and testing innovative treatments.

Clinical research has changed the face of modern medicine. At the end of World War II, physicians had little ability to effectively treat or prevent any of the deadliest diseases. Most of what we know as modem medicine, which we enjoy today were still unknown: antibiotics, vaccines for polio and several other severe infections, most hormone replacements and steroid therapy, effective drug therapies for cancer and psychotic illnesses, testing for genetic disorders, coronary bypass surgery, transplanted organs, and artificial joints. These and other successes have encouraged public enthusiasm for research and belief in the potency of modem medicine. Progress in cardio vascular disease, cancer, diabetes, infectious diseases, etc., would not have been possible without clinical research and funding that has supported the scientific discoveries. With similar enthusiasm, we can advance our understanding and treatments for keloid.

We do not even have statistics about keloid and do not know how prevalent this disease is. KRF intends to also develop a methodology to capture this data. We need to know how many people are suffering from this disease, so that we can effectively lobby for public and Federal research funds.

Medical research has visibly transformed the practice of medicine over the past fifty-sixty years, but even greater benefits may be possible in the future, if we are positioned to capitalize on the many profound developments that have recently occurred in fundamental science --- especially in genetics, structural biology, molecular and cell biology, computer science, and imaging technologies and applying all that to a keloid disorder, a disease that has been simply neglected by the research community.

Join us in an effort to advance our understanding of keloid and finding better treatments for it. Below is a listing of three keloid studies that are open and accruing. These three studies have been approved by IRB:

Trial 11-01: Web Based Investigation of Natural History of Keloid; An Online Survey of Patients with Keloid. The aim of this trial is to conduct a "10,000 patients" survey on the natural history of their keloids, and to explore patterns of clinical presentation, response to treatment and correlation with the ethnic background. This trial will provide valuable information about the prevalence of different keloid phenotypes.

If you have keloid, I strongly urge you to participate in this study. Click HERE for the link to this study's website

Click HERE for the link to this study's listing on ClinicalTrials.gov website

Trial 11-03: A Therapeutic Trial of intralesional bevacizumab in patients with non-pedunculated keloids. The aim of this trial is to establish safety and efficacy of intralesional bevacizumab in patients with flat keloids. Several publications have reported on up-regulation of VEGF pathway in keloid tissue. Based on these findings, we have initiated this study to harness on blocking the angiogenesis pathway by bevacizumab to explore whether this intervention will lead to any meaningful clinical benefit. This study is currently open only in New York office of Dr. Tirgan. Click HERE for the link to this study's website

Click HERE for the link to this study's listing on ClinicalTrials.gov website

Trial 11-04: Epidemiology Study of Keloid. Aim of this study is to determine the true epidemiology of keloid in general population. This will be a web based as well as paper questionnaire that is intended for mass distribution and collection of data. Sample size of this trial is (minimum of) 100,000. This will be a global trial. Each and every one of you can help this study by sending the link to the study website to all your friends and relatives and ask them to take this anonymous survey that only takes 1-2 minutes to complete. Also ask your friends to send the link to all their friends.

Click HERE for the link to this study's website

Click HERE for the link to this study's listing on ClinicalTrials.gov website

Trial 11-07: Keloid Radiation Registry. Aim of this trial is to establish safety and efficacy radiation therapy in treatment of keloid. Radiation therapy has serious long term side effects, including causation of cancer, etc. This study aims to clarify the role of radiation therapy in keloid disorder.

If you have received radiation for treatment of keloid, I strongly urge you to participate in this study. Click HERE for the link to this study's website

Click HERE for the link to this study's listing on ClinicalTrials.gov website

A central website has been made to link to all keloid studies. Click HERE for the link to this central website