Randomized Controlled Clinical Trials (RCTs) are considered the gold-standard type of clinical trial for determining the effectiveness of any hair loss intervention. Typically, RCTs are randomized, blinded, controlled clinical studies. Each one of these components can be defined in the following ways:
Randomized: The people inside of the study are randomly assorted into different groups. This is critical because it means that investigators aren’t exclusively evaluating specific individuals that would respond favorably to a treatment.
Blinded: Investigators or participants (or preferably both) don’t know which individuals are receiving the real treatment and which ones are receiving a placebo (sham device or sugar pill). This helps control for the placebo effect, which is when individuals see results because they think they’re taking the real medication.
Controlled: The treatment being tested is studied against a placebo group and a treatment control group. The placebo group receives a sugar pill or sham device, and a treatment control group uses a different FDA-approved option like Finasteride or Minoxidil. This allows the researchers to discern how effective their treatment is compared to a group who thinks they’re getting the real medication, and a group that is testing a treatment that is known to work.
If investigators fail to randomize, blind, and control their clinical study on a hair loss intervention, the results of that study might be subject to significant bias. For instance:
- Without randomization, investigators may or may not deliberately sort participants who are more likely to "shed" into the control group, thus increasing their likelihood of a positive outcome versus the control. This could be participants who recently withdrew from hair loss drugs, like minoxidil. We noted this problem in a study design supporting the use of Oxford Biolabs' TRX2® product line.
- Without blinding, investigators may or may not deliberately treat certain participants more favorably, thus opening those participants up to a higher likelihood of experiencing a placebo effect.
- Without a control group, investigators cannot know the impact of their treatment beyond the placebo effect or the seasonality of the hair cycle – of which both effects have the power to produce false positive and negative results in a study.