Virginia Clinical Research, Inc. is a physician owned and professionally managed independent research company, which is associated with a dermatology practice and dermatology residency program in Southeast Virginia.
Back Row: JoEllen Wyer, Tina Watkins, Dr. David Pariser,
Dr. Stefanie Hirano, Dr. Cyndi Torosky
Front Row: Danielle Benedict, Celina Davis, Becky Marushia
Not Pictured: Dr. Robert Pariser, Lisa Franklin, Anita Reaves, Dr.
Joan Paul
Joan Paul, M.D.
Position: Sub-investigator
A graduate of the Siena College/Albany Medical College Program in Sciene, Humanities, and Medicine, Dr. Joan (Joanny) Paul developed a passion for international medicine and humanitarian efforts. In medical school, she decided pursuing dermatology was the best way for her to have an impact in both developing countries, and underserved areas within the United States. She recently obtained an MPH from the Harvard School of Public Health with a concentration in Global Health, and she is currently the Director of Dermatology at Engeye Health Center in Ddegeya Village, Uganda - a clinic created by three of her classmates from Albany Medical College. Besides traveling for medical missions, Dr. Joanny enjoys running, playing lacrosse, reading, and watching movies.
Email : jpaul_vcrinc.org
Call : (757) 747- 2211
What is Clinical Research?
A clinical trial is a research study sponsored by a pharmaceutical company to evaluate the safety and effectiveness of an experimental medical device, treatment, or medication. After showing benefit in the laboratory, new treatments must be tested among small groups of people to determine the proper dose and to test safety. After a dose has been determined, the dose is tested on large groups of volunteers to evaluate the safety and effectiveness of the treatment for a specific condition, such as eczema, psoriasis, or acne.
The Food and Drug Administration (FDA) requires pharmaceutical companies to conduct clinical trials before new treatments can be made available to the public for prescription or over the counter use. Clinical trials are carefully monitored under the FDA’s strict regulations.
Clinical trials are important to ensure that people receive safe and effective treatments. The trials provide a way to develop new treatments that are as effective, more effective, or safer than treatments already on the market. The trials also make it possible to develop new treatments for conditions that currently have no treatments available.
Are there risks and/or benefits to participating in clinical trials?
What is a placebo?
What is an Informed Consent?
What are the responsibilities and cost associated with participation?
How does a person become involved in a clinical trial?
Is a patient’s study participation and medical information kept confidential?
What protection does a patient have as a participant in a clinical trial?
601 Medical Tower
Norfolk, VA 23507
Map of Campus
Directions from Virginia Beach
Directions from the Midtown Tunnel
Directions from 664/Newport News / Suffolk
Phone: (757) 747- 2211
Phone: (757) 747 - 2211
Fax: (757) 625 - 6212
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Danielle Benedict
Position: Manager and Research Coordinator
Danielle has been working in the clinical research industry since 2007. She began her career in Boynton Beach Florida with Visions Clinical Research. When she returned to her home state she joined Virginia Clinical Research as the Patient Recruiter/Clinical Research Coordinator. She now oversees Virginia Clinical Research as the Clinical Operations Manager. Despite her Virginia roots, she is a huge fan of the Dallas Cowboys.
Enrolling Studies:
Email: dbenedict_vcrinc.org
Call: (757) 747- 2211
JoEllen Wyer
Position: Research Coordinator
JoEllen Wyer came to VCR in 2009 from an entrepreneurial background in health care management and finance. Her experience working in the health care arena spans two decades. JoEllen is responsible for subject recruitment, screening, and patient care as a Clinical Research Coordinator. She is a natural born foodie and is passionate about cooking and entertaining friends. On her spare time you can find her catering events for family, friends and the public.
Enrolling Studies: Severe Facial Acne
Email: jwyer_vcrinc.org
Anita Reaves
Anita was born and raised in Brooklyn, New York. In 2002 she relocated to Virginia and obtained a position as a Research Assistant/Recruitment Specialist. Her passion for research flourished and within one year she was promoted to a Research Coordinator. She conducted studies in various therapeutic areas such as pain management, weight loss, women's wellness, hypertension, osteoarthritis, hyperlipidemia, psychiatry and diabetes. She is a recent addition to the VCR family, but with her extensive experience she quickly adapted. In her free time she loves cooking, traveling, volunteering in her community, and spending time with her 3 sons and grandchildren.
Enrolling Studies: Psoriasis (Registry study)
Tinea Pedis(Athlete's Foot)
Email: areaves_vcrinc.org
Call: (757) 747-2211
David M. Pariser, M.D.
A Medical College of Virginia graduate, Dr. David Pariser received his dermatology training at the University of Miami/Jackson Memorial Medical Center. He is on the Board of Directors of the American Academy of Dermatology and is currently a professor of the Eastern Virginia Medical School Department of Dermatology. As the senior dermatologist in the practice, Dr. David Pariser has brought over two decades of experience to tens of thousands of patients in the Hampton Roads area. In addition to his clinical practice, Dr. David participates in clinical research and is in the forefront of pharmaceutical development in the field of dermatology.
Quite active in the affairs of the American Academy of Dermatology, Dr Pariser has served on over 85 committees including the committee on Guidelines of Care, Managed Care, Task forces on Universal Health programs, Scientific Assembly Committee, Health Care Reform Issues and Regulatory Affairs, and the Advisory Board for which he served as Vice-Chair for two 4-year terms. He has been a representative to the Medicare Carrier Advisory Committee for Virginia, and is a past Chair of the Committee on Organizational Structure of the American Academy of Dermatology and was Assistant Secretary-Treasurer for 3 years, Secretary-Treasurer for 3 years and a Board member of the Academy for 10 years. He was the 2009 President.
Cyndi M. Torosky M.D.
After graduating from Eastern Virginia Medical School, Dr. Torosky completed a Research Fellowship with Virginia Clinical Research and returned to EVMS for her residency training in dermatology. Her professional affiliations include the American Medical Association and the American Academy of Dermatology. Dr. Torosky enjoys treating patient with acne and rosacea as well performing cosmetic procedures such as chemical peels, Botox® Cosmetic and dermal fillers such as Restylane, Juvéderm and Radiesse. In her free time she likes to downhill ski, travel and spending time with her friends, family, and her German Shepherd Dog Otto.
Becky Marushia, CCRC
Becky Heroux has been a Certified Clinical Research Coordinator since 1997. She has been with Virginia Clinical Research since its inception helping to successfully complete more than 250 clinical studies specializing in Dermatology. She has assisted Dr. David Pariser in the success of VCR and continues to do so. She also has extensive regulatory and budgeting experience. In her spare time she is a busy mom to two teenagers who are very involved with fast pitch softball and baseball.
Enrolling Studies: Hair Loss (baldness) in Females
Psoriasis Patient Narative Study
Email: bmarushia_vcrinc.org
Lisa Franklin
Position: Research Coordiantor
Lisa Franklin has come to VCR from her hometown of San Diego, CA. From there she has brought with her 6 years of clinical research experience from a broad range of specialties. Since 1992, Lisa has continued to contribute to the medical community in areas such as womens health, psychiatry, and convalescence for the aging and independent.
You can often find Lisa running outdoors, sampling fine cuisines, spending time with her family and singing karaoke.
Enrolling Studies: Psoriasis
Email: lfranklin_vcrinc.org
Tina Watkins
Position: Registered Nurse and Research Coordinator
Tina Watkins was born and raised in Virginia Beach, Virginia. She attended Old Dominion University and received a Bachelor of Science in Nursing. Since 2004 she has worked as a clinical research coordinator with Virginia Clinical Research. In her spare time she enjoys spending time with her two daughters, cooking from Julia Child cookbooks, traveling, and hot yoga.
Enrolling Studies: Sarcoidosis
Psoriasis
Childhood Psoriasis
Onychomycosis
Email: twatkins_vcrinc.org
ONYCHOMYCOSIS
(TINEA UNGUIUM or TOE NAIL FUNGUS)
ENROLL IN A CLINICAL TRIAL FOR ONYCHOMYCOSIS
What is Onychomycosis?
Onychomycosis (also called Tinea unguium) is a fungal infection of the nail. It includes all types of fungus, both dermatophyte and non-dermatophyte. This is a very common but frustrating disorder because of the difficulty to successfully treat. The challenges of treatment include lack of long term effectiveness, possible effects of systemic medications, and the frequent recurrence of the disease. Some patients consider the disease simply annoying or visually unpleasing, but for other is can be painful and limits activities such as running and dancing.
Onychomycosis affects men more than women, and is often (but not always) associates with chronic tinea pedis (foot fungus of the skin). Toenail infections are more common than fingernail infections, and fingernail infections rarely occur without concurrent toenail infection. A single nail or multiple nails may be affected.
What does Onychomycosis look like?
Nails that are affected may become thickened, may split, and may develop yellowing.
(Toenail fungus)
This study will investigate the safety and efficacy of AB2690 , a topical solution, in the treatment of Onychomycosis. This is a placebo controlled study, meaning that a portion of the participants will receive placebo (no medication). The study is sponsored by Kendle International Inc. and Anacor Pharaceutical.
Quick Facts:
Contact: Tina Watkins, RN
(757) 747- 2211
twatkins_vcrinc.org
Current Clinical Trials
Sarcoidosis
Hidradenitis Suppurativa
Lupus
Tinea pedis (athlete's foot)
Severe Facial Acne
Scalp Hair Loss (Baldness)
A study designed to evaluate the safety and efficacy of topical bimatoprost (active ingredient of Latisse) compared to minoxidil (Rogaine) in female patients with mild-moderate scalp hair loss for at least a year.
**ENROLLMENT CLOSED**
Contact : Becky Marushia
bmarushia_vcrinc.org
Tinea Pedis (Athlete's Foot)
The study is designed to assess the efficacy and safety of Econazole Nitrate foam and Econazole Nitrate cream in the treatment of interdigital Tinea Pedis. This study is placebo-controlled, meaning that a portion of the participants will receive placebo (no medication). The study is supported by Quinnova Pharmaceuticals Inc.
Contact: Anita Reaves
areaves_vcrinc.org
What is Tinea Pedis?
TINEA PEDIS
(ATHLETE'S FOOT)
ENROLL IN A CLINICAL TRIAL FOR TINEA PEDIS
Tinea Pedis is a fungal infection of the skin on the feet. It often causes scaling, flaking, and itching of affected areas. Tinea pedis usually occurs between the toes and within the spaces between the fourth and fifth toes. It is caused by fungi in the genus Trichophyton and is typically transmitted in moist areas where people walk barefoot, such as showers or locker rooms. Tinea pedis can be diagnosed by skin culture, skin biopsy, or skin KOH exam.
What does Tinea Pedis look like?
Tinea pedis usually affects the skin between your toes and on the bottom of your foot. Visible signs are flaking, peeling, and cracking. The area affected is usually red and itchy.
Celina Davis
Celina Davis found her love for clinical research in 2002 when she began her career as a medical assistant. She has since expanded her experience in research to envelop a wide range of therapeutic areas- including dermatology, ophthalmology, endocrinology, cardiovascular, skeletal-muscular, pain management, genitourinary, gastrointestinal, and rheumatology. She enjoys the challenges of the job as well as the opportunity to share in the lives of her patients. Besides her training in medical assisting, Celina also has a degree in Education. She spends her free time with her husband and son and enjoys travelling, the beach, art and photography.
Email: cdavis_vcrinc.org
Robert J. Pariser M.D.
After graduating from the Medical College of Virginia, Dr. Robert Pariser completed dermatology specialty training at the University of Miami/Jackson Memorial Medical Center. He is a professor in the Department of Dermatology at Eastern Virginia Medical School. Also, he is an associate professor of the Department of Pathology at Eastern Virginia Medical School. An AMA member, as well as a member of the American Academy of Dermatology. Dr. Robert Pariser enjoys the challenge of seeing both general dermatology and clinical research patients, in addition to being a respected dermatopathologist.
Risks and Benefits of Participation
Are there risks to participating in clinical trials?
Although every effort is made to minimize potential risks, there may be side effects and other health risks not yet known. Side effects differ from one person to another, and there is no way to predict how the treatment will affect any individual. Potential risks to participants include the possibility of receiving an inactive treatment (placebo) or a study treatment may be ineffective for some patients. In these cases, the participant’s condition may worsen. Foreseeable risks will be listed in the Informed Consent Form.
Are there benefits to participating in clinical trials?
Volunteers who participate in clinical trials help to further advance medical science, which may help others in the future. There are no guarantees that participants will directly benefit from the treatment they receive, but some participants may find that the study medication relieves their condition more effectively and with fewer side effects than currently available treatments. Other benefits include free study medication and study related office visits as well as financial compensation (reimbursement for time and travel).
Is a patient's study participation and medical information kept confidential?
Informed Consent and the Possibility of Placebo
A placebo is an inactive substance that contains no medication. Clinical trials may use a placebo to evaluate the effectiveness of the active ingredient in the study medication.
Informed consent is the process by which a potential study participant is provided with information about the study and treatment. It is used to assist the participant in deciding whether or not to participate in the trial. The informed consent includes information on why the study is being conducted, what will be done during the study, how much time is involved, potential risks and benefits, and a listing of who to contact in an emergency.
Participation in a clinical trial is completely voluntary. All questions about the study should be answered completely before the informed consent form is signed. Patients have the right to refuse participation or to withdraw from the trial at any time during the study without the risk of a penalty.
Is a patient's study participation andmedical information kept confidential?
Responsibilities and Cost of Participation
What are the responsibilities of a participant?
The participant must give a full and accurate medical history regarding past and current medical conditions, illnesses, and all medications used currently and in the recent past. The participant must follow all directions regarding the use of the study medication, and return all medication upon the completion of the study. They must attend all scheduled appointments to ensure that the study doctor monitors the progress of the participant.
What are the costs associated with participation?
There is no cost to participate in a clinical trial. All study medication and study related office visits, procedures, and laboratory tests are provided at no cost to the participant. Participants may be responsible for costs such as parking or meals. Financial compensation at the completion of the trial is provided to cover such costs.
There are many ways to find out about clinical trials, including advertising, listings on the internet, mailings, radio and television commercials, word of mouth, and physician referrals. Patients looking for a clinical trial for a specified condition should discuss the available options with their physician.
Once a patient contacts a research site, the caller will usually have a brief telephone interview to determine if he or she would likely be a good candidate for
the study. A screening visit may then be scheduled for the candidate to discuss the trial in more detail and to further screen the candidate for qualification, possibly resulting in study enrollment.
To find out what studies Virginia Clinical Research, Inc. is currently enrolling patients in please refer to Current Clinical Trials.
Confidentiality and Protection
Patient confidentiality is maintained as much as possible during and after a clinical trial. The patient’s name may not be disclosed without the permission of the participant unless required by law. The study doctor, the sponsor, FDA, and the IRB have access to the patient’s medical records. To ensure confidentiality, a patient is identified throughout the study by a number assigned to them along with their initials.
Clinical trials are governed by clearly defined ethical and legal codes. In 1981, regulations of the Food and Drug Administration made it a requirement that all federally regulated clinical trials be reviewed and approved by an Institutional Review Board (IRB) before and during the course of the trial. An IRB is a committee of volunteers, including experts and lay people such as doctors, scientists, clergy, and other community members. Their primary goals are to protect the patient, to evaluate whether the potential benefits outweigh the potential risks, to ensure that patients are fully informed about the study before enrolling and that they are not being coerced to participate. Study protocols and the progress of the clinical trials are periodically reviewed by the IRB as well as by the study sponsor. The FDA and other governmental agencies oversee the IRBs. Patients may call the IRB with questions about their rights as a research participant.
Take 264 toward downtown Norfolk
Take exit 11B to E Brambleton Avenue
Continue on Brambleton across the bridge at the Hague
Go straight through the light at Colley Avenue (get in the right lane)
There is an entrance to the Medical Tower on the right with a small sign
We are located in the tall gray building on the right (parking is on the left)
Bring your parking ticket with you so that we may validate it for you
We are located on the 6th floor in Suite 601
Fax: 757-625-6212
Directions Main Page
Directions from Midtown Tunnel
Go through the Midtown Tunnel
Take the second exit (NS Railways, Medical Tower)
Go to the stop sign (do not go up the hill) then cross Hampton Blvd to the next stop sign
Take a right (you will be behind Sentara Norfolk General
At the next stop sign, you will be looking at our building. Take a right and the parking lot will be on your right
Take exit to highway 164 (Western Freeway)
Follow until you go across the bridge, then get in the left lane
Go until the road makes you turn right, then get in the right lane
Go to the stop light then merge into the left lane
Take a left on Cleveland Street (sign says to Midtown Tunnel)
Follow through Midtown tunnel
At VCR we usually have multiple ongoing studies for psoriasis. The following is our current enrolling pediatric study.
This study is for treatment of psoriasis in children. The study is designed to evaluate the efficacy and safety of Taclonex ointment in treating psoriasis. This study is not placebo-controlled, so all of the participants will receive the study medication.
What is Psoriasis?
The study is designed to assess the efficacy and safety of Adalimumab in the treatment of cutaneous (skin) sarcoidosis. This is an investigator initiated study, meaning that our facility initiated, designed, and sponsored the study. The first 12 weeks of the study are placebo-controlled, meaning that some of the study participants will receive placebo (no medication). However, the second 12 weeks is open-label, so all participants will receive the medication. This study is supported by Abbott.
Quick Facts :
What is Sarcoidosis?
The study is designed to assess the efficacy and safety of Visonac PDT in the treatment of severe facial acne.
This study is placebo-controlled, so participants will either receive the study medication or placebo. The study is supported by Photocure Corporation.
Contact: JoEllen Wyer
jwyer_vcrinc.org
What is Severe Facial Acne ?
Chronic Plaque-Type Psoriasis
The study is designed to assess the efficacy and safety of secukinumab in the treatment of moderate-severe chronic plaque-type psoriasis.
This study is placebo-controlled, so participants will either receive the study medication or placebo. The study is supported by Novartis.
Contact: Lisa Franklin
lfranklin_vcrinc.org
Lichen Planus
The study is designed to assess the efficacy and safety of Apremilast in the treatment of moderate to severe lichen planus.
This is an investigator initiated study, meaning that our facility initiated, designed, and sponsored the study. This study is not placebo-controlled, so all participants will receive the medication. The study is supported by Celgene Corporation.
Contact: Celina Davis
cdavis_vcrinc.org
What is Lichen Planus?
Epidermolysis Bullosa
A study designed to evaluate the efficacy and safety of Thymosin Beta 4 in the Treatment of Patients with Epidermolysis Bullosa (EB).
Contact: Danielle Benedict
dbenedict_vcrinc.org
What is Epidermolysis Bullosa?
Psoriasis (Adult)
At VCR we often have multiple ongoing studies for psoriasis. The following are our current enrolling studies:
STUDY 1: Novartis sponsored
The study is designed to evaluate the treatment of psoriasis with secukinumab injections . The study is placebo-controlled, meaning some participants will receive placebo (no medication).
- Females must use at least one form of birth control
STUDY 2: Psolar sponsored
This is an observational registry study to monitor the efficacy of various psoriasis treatments. No medications will be provided during the study.
Age 18 and older
Patients must have plaque psoriasis and be eligible for biologic therapy
Study Duration: 8 years, 2 office visits a year
CONTINUE TO MORE PSORIASIS STUDY (STUDIES 3-4)
At VCR we often have multiple ongoing studies for psoriasis. The following are our currently enrolling studies (continued from previous page):
STUDY 3 : Pfizer pharmaceutical sponsored
This study is designed to evaluate the safety and efficacy of CP-690,550 oral medication . This medication is a Janus Kinase family inhibitor. The study is placebo-controlled for the first 16 weeks, meaning that about 20% of participants will receive placebo (no medication) for the first 16 weeks. However, from week 16 to the end of the study (week 52), all participants will receive the drug.
Contact: Tina Watkins
STUDY 4 : Janssen Biotech Inc. sponsored
This study is designed to document subject experience with psoriasis.
(757) 747-2211
RETURN TO PREVIOUS PSORIASIS STUDY PAGE (STUDIES 1-2)
Atopic Dermatitis (Eczema) in Children
A study designed to evaluate the safety and efficacy of a topical treatment in children with atopic dermatitis. "Topical" means that the treatment is being put on the skin. This study is not placebo-controlled, so all the participants will receive medication.
Contact : Becky Heroux
bheroux_vcrinc.org
What is Atopic Dermatitis (Eczema)?
Facial Wrinkles
This study is designed to study the safety and efficacy of Allumera topical cream AND light therapy in subjects with facial fine lines and wrinkles. This is a cosmetic study with the goal of improving the appearance of wrinkles.
This study is open-label, meaning that all of the participants will receive the cosmetic cream and no subjects will be given placebo. After the application of the cream, half of the subjects with then be treated with red light and half with blue light. This is an investigator initiated study, meaning that the doctors at VCR designed and are sponsoring the study. This study is funded by a grant from Photocure.
jwyer_virginiaclinicalresearch.com
A study designed to evaluate the safety and efficacy of injections of ex vivo expanded cultured occipital autologous dermal and epidermal cells (cells cultured from your own skin cells) in patients with scalp hair loss.
PSORIASIS
ENROLL IN A CLINICAL TRIAL FOR PSORIASIS (Adult)
ENROLL IN A CLINICAL TRIAL FOR PSORIASIS (Children)
Psoriasis is a chronic, autoimmune disease that appears on the skin and nails. It most commonly appears as red patches with silvery scale. These patches are caused from inflammation and excessive skin production. Skin rapidly accumulates at these sites and is a silvery-white appearance. Plaques frequently occur on the skin of the elbows and knees, but can affect any area including the scalp, palms of hands and soles of feet, and genitals. A person with psoriasis can have only a few small plaques or can have total body involvement.
Psoriasis can also cause inflammation of the joints, which is known as psoriatic arthritis. Five to thirty percent of people with psoriasis have psoriatic arthritis.
The cause of psoriasis is not fully understood although it is thought to be an immune-mediated disorder. The disease is believed to have a genetic component. Various environmental factors have been suggested as aggravating to psoriasis including stress, withdrawal of systemic corticosteroid, excessive alcohol consumption, smoking, skin injury, infections (especially streptococcal infection), weather changes, and certain medications. There are many treatments available, but because of its chronic recurrent nature psoriasis is a challenge to treat.
ACNE VULGARIS
What is acne?
Acne (also called acne vulgaris) is a chronic disease of the skin which is most notable on the face, chest, and back. It is caused by many factors including bacteria, blockage of the sweat ducts, hormones and many others. There is a wide spectrum of acne and many different types of acne. Although all age groups can be affected, it is primarily a disease the affects teens and adolescents. Acne affects about 40-50 million people each year in the United States.1 Acne has a profound image on self-consciousness and social interactions of those affected. If not appropriately treated, acne may cause serious physical and emotional scarring and can significantly impact the quality of life of those affected by the disease.
What causes acne?
The cause of acne vulgaris is to be the product of increased sebum (oil) production, obstruction of the hair follice unit, increased growth of certain bacteria (Propionibacterium acnes) in the hair follicles, and inflammation of the skin. (P. acnes) residing in pilosebaceous follicles, and inflammation.
Sorry, there are no currently enrolling acne studies. Frequently check back with our website, as we are constantly starting new studies.
SARCOIDOSIS (CUTANEOUS)
ENROLL IN A CLINICAL TRIAL FOR SARCOIDOSIS
What is sarcoidosis?
