Learn How You Can Participate in a Hair Loss Clinical Trial




“There is very little research on hair loss treatments to date, compared with other medical and health conditions,” says dermatologist and hair loss specialist Dr. Valerie Callender, director of the Callender Skin & Laser Center in Maryland. “Clinical studies on real human volunteers who answer specific health questions and try experimental treatments to determine their safety and use under specific and controlled environments are the fastest and safest way to find hair loss treatments that work in people and get them approved.”

But, she cautions, there is a lot you need to know if you think you want to participate in a study or try study-related treatments for your hair loss.

Hair loss studies: What you need to know

  1. Understand the hair loss drug and treatment approval process by the FDA. According to the National Institutes of Health (NIH), the U.S. Department of Health and Human Services agency is responsible for ensuring the safety and effectiveness of all drugs and medical treatments and works in conjunction with the U.S. Food and Drug Administration. The approval process for new drugs and treatments is composed of several steps — preclinical laboratory and animal studies, clinical human trials for safety and efficacy, and many filings, reviews and approvals.
  2. Understand your own particular hair loss condition. “Get a diagnosis from your doctor and clearance to participate in study-related treatments for your hair loss,” advises Callender. Then you can quickly search and find studies specifically related to your hair loss condition on the official government clinical trial registry of the NIH at www.clinicaltrials.gov.
  3. Consider the hair loss treatment trial phase of the study. This makes a difference in your comfort level in using experimental treatments. According to the NIH, Phase I tests a new drug or treatment in a small group of people, Phase II expands the study to a larger participant group. Phase III expands the study even further, and Phase IV takes place after the drug or treatment has been licensed and marketed.
  4. Research who is paying for the hair loss treatment study. This sponsor could be a government agency such as the NIH, a pharmaceutical or medical device company, a public institution such as a university or medical college or an individual person. Also learn about the principal investigator, usually a medical doctor, responsible for conducting the research. Your own physician may be the principal investigator in a community-based clinical trial that would conduct studies primarily through primary-care physicians rather than academic research facilities.
  5. Learn about randomization and blinding in hair loss treatment studies. “These protocols will drastically affect your experience in the study,” says Callender. Usually subjects are assigned “randomly” to groups that may receive different doses, drugs, devices or procedures, so that neither the subject nor the investigator chooses the groups. “This helps ensure more accurate study results, but if you are a participant, it means that you may not be in the group that receives the active drug or effective dose, and you will not know it,” she cautions. Another study technique called “blinding” means that the subjects and often the investigator do not know which group receives which drug or dose, which helps eliminate any bias by the investigator or the subject, also for more accurate results. “One common way to blind a study is to use a placebo (an inactive dose or treatment), and as the participant, you could be in the placebo group,” says Callender.

Learn about the hair loss study

Dr. Callender, who runs research studies herself, advises patients interested in participating in clinical studies to look them up on the aforementioned official website to learn the specifics of each study, as outlined above, in order to see if the study meets your needs or your interests. Then carefully read and consider the consent form, which should provide the following information:

  • Purpose of the study
  • Duration of your participation
  • Potential benefits
  • Potential risks
  • Standards of treatment for your hair loss condition
  • Compensation for your participation
  • Research-related injury protocol
  • Who will receive study information about you

“Whether you are interested in trying a new treatment that may or may not help your condition or simply contributing to the advancement of science and the medical literature, learn everything you can about the study so you can make an informed decision about participating,” concludes Callender.

Resources for hair loss patients: