Clinical Research 101
There is research and there is clinical research. It’s considered the highest research bar to prove a treatment is effective and safe for people. Clinical trials are required before medicines and vaccines can be made available. They are NOT required for cosmetic beauty products, but a few beauty products choose to go to these lengths to know what they are offering really works.
So, what makes research “clinical”? It’s easy to picture a stark white, cold lab, but that does not make research “clinical”. Simply put, clinical research is done on people and to benefit people.
There are different degrees of clinical rigor. Here are a few terms that give clues for how rigorous a study is:
- RANDOMIZED indicates participants are divided by chance into separate groups – a test group and a control group – they are not divided by certain features. Imagine you wanted to test how well a cup of coffee can wake people up in the morning, but you had more night owls in one group and more early birds in the other. You would not know if the more energetic people were rev’ed up by coffee or by just because they are an early bird.
- PLACEBO-CONTROLLED means the control group receives an inactive treatment, a.k.a. the placebo - an inactive control that accounts for the placebo effect (when the act of using something has a therapeutic effect even if there are no active ingredients). For the coffee wake-up clinical, the placebo may be decaf coffee to account for how much the act of drinking something that looks, smells and tastes like caffeinated coffee has on how awake you feel, when no caffeine is involved.
- DOUBLE-BLIND means neither the study participants nor the people running the study know which participants get the test treatment nor who gets the placebo. Back to the example of the coffee clinical study – neither the clinical administrators (the scientific coffee servers) nor the people in the study know who is getting what cup of coffee – decaf or caffeinated.
The Gold-standard in clinical research is randomized, placebo-controlled, and double-blinded studies.
The number of people in a study matters too, but there is no magic number that works for all studies. It depends on what you’re testing. Thousands of participants are needed to test vaccine candidates when chances are small for naturally coming into contact with the disease you are trying to prevent. However, studies for something more common, like diaper rash, can be done with a much smaller number of participants (e.g., 50). For the few cosmetic products that are clinically tested, they are often run on fewer than 100 participants.
Wondering why AREN'T all hair loss treatments clinically proven?
Doing research on people rather than hair tresses (picture cut ponytails hanging on a clip) is not easy.
- People are far more complex than lab samples.
- Study participants need to follow detailed and specific directions for however long the study lasts. When studies last for weeks or months, up to 30% of participants may drop out because they don’t want to follow the instructions for that long.
- And then there is the cost. Clinical research can be extremely expensive – easily into the six figures. When you’re doing something really new, really big, that investment can be worth it to know it really works!
How does KeepItAnchored’s clinical study stack up?
While KeepItAnchored is technically considered a cosmetic product, it was held to the standard of a clinical study to be sure the hair anchoring technology really works to reduce hair loss. We had to be sure this was not another broken promise for those wanting to keep more of their hair.
The Hair Anchor blend in KeepItAnchored was tested in a 6-month, randomized, placebo-controlled, double-blinded clinical study that included 300 male and female participants. Results showed those who used the system with the Hair Anchor blend had up to 2400 more hair fibers on their head at the end of the study.
You can read more about it here or check out the clinically proven Complete Kits below: