clinical studies

Clinical studies for beauty products help to give new brands credibility. Because in today’s current market, you need to take advantage of every upper hand that you can get.

Choices of Study Types

While the design of your study is important, the type of study that will be conducted is one of the most integral parts of the process. Will the study be unblinded or blinded? Does the study administrator know what they are evaluating? Do the volunteers know? There are Monadic studies, crossover studies, and placebo-controlled studies.

A Clinical Study Outline For Design

Let’s take a look at a sample outline for the design of a clinical study using bullet points:

  • This will be a placebo-controlled, 12 week double-blind evaluation of a dietary supplement. Two groups will be assembled. After a randomized selection, 30 people will be included in each group.
  • The benefits of this product are said to cater to a particular population that has experienced wrinkles. The gender requirement is nonspecific. Clearly, the subjects of the study must have wrinkles.
  • Two groups consisting of men and women, age 45 to 65, will be assembled. The study will take place over 12 weeks with a baseline visit, a six week visit, and a final 12 week visit.
  • Parameters to be evaluated will be hydration, skin firmness, and wrinkles and fine lines. To help document product effect, adding clinical photography will be of great assistance. Adding an expert or grader to the mix will also help gain clinical relevance.
  • Note: The idea of adding a questionnaire is considered, by some, risky. A study is considered more reputable and reliable if it is evaluated and commented on by experts.
  • Subjects must, in order to be eligible, not be using any antiaging or moisturizing products before-hand or during the study. They will also need to sign an informed consent.
  • One group will use the actual product while the other group uses a placebo.
  • For each visit, subjects will spend approximately 30 minutes in a controlled environmental room for application/ingesting purposes and results observance.

Got Your Outline?

Using a study schedule and study outline, you (as the product creator) would create a protocol. For the entire study, this would be the overriding document. The protocol would include the study schedule in detail, all the parameters that appear in the design of the study, and the methodology for grading scales and instrument used for expert graders. The primary investigator would sign the final protocol as well as the study sponsor and any sub investigators.

Final Suggestions

When, at a contract facility, placing a study of this nature, here are some things to look for.

Audit the laboratory for the following:

  • Technical staff
  • Training of expert graders
  • Calibration

Make sure the data makes sense because you are responsible for any claims made. Within the data, there should be some variance because, where your product is concerned, not all subjects will have the same reaction. There’s an old adage that holds up pretty well here: “If it looks too good to be true, it likely is.”

Architectural Beauty can assist you with your clinical studies and trials, as well as every aspect of creating, packaging, testing, marketing, and more. If you would like to find out about additional information, contact us today.