Research literally means "look again." It employs the scientific method to examine and re-examine issues of medical importance. It means that we must prove, beyond a doubt, that what we are studying is of benefit to those who will ultimately use the product.
Dermatology research is aimed at studying issues related to the skin. Products that are used on the skin may be substances for adornment, such as cosmetics, fragrances, or skin care products. They may products designed to improve the functioning of the skin, such as antiperspirants, sunscreens, antiaging creams, and cosmeceuticals. Prescription products are also applied to the skin for conditions, such as psoriasis, hair loss, eczema, or acne. We study all of the above!
The scientific method is the basic technique we use to obtain reliable answers to the important questions we are asking. It means that we must first come up with an idea of the results we hope to obtain from our research, also known as the hypothesis. We must then design a study that answers this question. A reliable study usually compares the new product with something that is already existing to see if the improvement seen from the new product is worthwhile.
We select our projects based upon our patient’s needs, with particular emphasis on skin care products addressing issues of appearance. Generally, we are approached by a company that wishes to develop a new cosmetic or drug. They present us with some general ideas and request that we sometimes assist in the development of the product and then perform the clinical testing. It is important that we have a company behind our research studies, since performing research is an expensive undertaking.
Many of the products we study find themselves on the shelves of stores and pharmacies. We try to select only the very best and most promising products for research. Research is a lot of work and we want to make our efforts count!
The primary benefit of participating in a research project is obtaining state-of-the-art products to treat a skin problem you may have that has not responded to prior treatment. All of our study visits and skin care products are provided to you free of charge. Your progress is also documented in a way that can only be done as part of a research project with photographs and other machine measurements.
We are committed to making your experience at our research facility pleasant and fun. Your safety is of utmost importance to us and we would not select any research projects that are not safe. We will present you with an informed consent at the start of every study to let you know the mechanics of the study and detail for you any known risks. Our studies are designed to improve your skin condition, not cause problems. If unforeseen problems develop, we will release you from the study and do our best to meet your needs. We will also try to make your time at our study center as efficient as possible. We spend hours setting up our research equipment and testing the equipment for optimal functioning. However, much of our equipment is quite costly and quite temperamental. Occasionally, we get behind. Please understand that we value your time and will move along as quickly as possible.
A lot of organization, time, and money is put into preparing every study we perform. We must organize all the study documents, package the study product, and obtain honoraria funds. The honorarium is designed to cover your time and traveling expenses to come to the research center. It is unwise to participate in research studies as a source of income. We depend on you to come to the research center in a timely fashion on the date of your scheduled appointment. We also depend on you to use the study product in the manner described. Poor compliance results in bad research data. We want to know your frank opinions, both good and bad, regarding whatever we are studying. Above all, remember that when you enroll in a research study you are giving us your commitment that you wish to participate. If after reading the consent form you feel that you cannot fulfill the requirements, please do not enroll. Let someone else who really wants or needs to participate have your spot. We cannot reuse or re-enroll your spot after you dropout. If too many people discontinue prior to conclusion of the study, all of our efforts are lost and our study is worthless. Do not enroll if you do not intend to complete!
Our studies are voluntary. You may discontinue at any time, but please give careful consideration to your commitment to us and our commitment to you before you enroll. We are responsible for you and the study products we give you throughout the research study. Prior to voluntarily discontinuing you from any study, you must return to the research center and return the study product. You may not discontinue simply by not returning to the study center. Failure to return to the study to discontinue results in a poor evaluation for our research center and compromises our ability to obtain future research projects.
At the end of a study, we collect all of the study products and try to give you an idea of how well your skin did with the study product. We try, if at all possible, to continue you on the study product either by providing samples or a prescription. Once the study data has been tabulated and analyzed, we will mail you a letter containing the results. It is usually one to two months after the study concluded that the results are available. We typically provide our honorarium checks at the end of the study, as well.
Dermatology Consulting Services is fortunate to have a highly trained staff to assist you during the research. Your progress is monitored by a clinical research coordinator and a research nurse. Research office staff will greet you when you come for your visit and assist in filling out forms. All of the research staff are educated on the research protocol and ready to make your experience interesting and rewarding.
Dr. Draelos is a board-certified dermatologist with special training in medical research. She has over 20 years of research experience. She has assisted in the development of many of the study products and writes many of the study protocols. She has performed research studies for over 30 companies worldwide, selecting on the best and most promising products for study here in High Point. She is available to answer any questions you may have regarding your participation in our research studies.
We announce our research studies by placing a notice in the Life Style section of the High Point Enterprise. If we know you are interested in a participating in a study, you may place your name on our research list and we will call you as studies launch. We also will periodically mail announcement letters to our patients who have unique skin conditions that might benefit from some of the products we study.
Participating in a research study is worthwhile and fun. It provides an opportunity to gain insight into how skin care products are developed and tested. You will recognize many of the products you helped study on the store shelves. It gives you new insight into the phrase "dermatologist tested!"
It is important that you wash your face for two reasons. First of all, if your study requires facial photography you must have a clean face. Any oil or make-up (and yes ladies this includes your eye make-up and lip cosmetics) becomes a distraction in the photo. The photos taken are to be as precise, anonymous, and replicable as possible. Secondly, if your study requires a facial assessment of any kind (i.e. rosacea, acne, etc.) your face must be free of make-up so that Dr. Draelos can evaluate your complexion accurately.
Urine pregnancy tests are administered when it is specified in the study protocol. Not all products or medications are harmful to an unborn fetus therefore not all protocols require a urine pregnancy test. Sometimes the protocol requires us to administer urine pregnancy test because the effect on an unborn fetus in unknown due to the fact that many of our studies involve investigational drugs (drugs not approved by the FDA).
It is our office policy to administer urine pregnancy test to all females 55 years and under unless you have written documentation indicating surgical sterilization.
No. You can participate in only one study at a time, and must allow 4 weeks between certain studies before you can enroll into a new study.
We do not have the answer to this question because every study night is different. Some nights we have a low number of subjects scheduled to come in, and sometimes we have a higher number of subjects scheduled. It is best if all study patients do not arrive at the same time. Early arrival is not recommended.
Yes. Anyone under the age of 18 years must have a parent present the night of enrollment to sign the informed consent form. No exceptions! Minors must have parental consent to receive medical care at our office.