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The Ingredients of Skin Care Research
By Kimberly J. Heathman
Posted: July 19, 2007
page 3 of 5
Mixing it up
Here’s the standard recipe for valid scientific research, listed by key “ingredients.”
Clinical trials. Also called medical research and research studies, clinical trials are experiments designed to test the effectiveness of a treatment or intervention, as well as its potential for use as a pharmaceutical or clinical agent. To conduct this type of clinical trial, an Investigational New Drug (IND) Application must be filed with the U.S. Food and Drug Administration (FDA).
If the FDA accepts the IND application, clinical trials in human subjects can be conducted. Tests may be preventative, diagnostic or therapeutic. Volunteers or paid subjects are generally divided into two or more groups, including a control group that does not receive the experimental treatment, instead receiving a placebo or inactive substance. They may also receive a verified, tried-and-true therapy for comparison purposes.1
Clinical trials may be conducted by government health agencies, such as the National Institutes of Health, researchers affiliated with a hospital or university medical program, independent researchers or those in the private sector.
Typically, government agencies approve or disapprove new treatments based on clinical trial results. While important and highly effective in preventing obviously harmful treatments from coming to market, clinical research trials are not fool-proof in discovering all side effects, particularly those associated with long-term use and interactions between experimental drugs and other medications.
Independent research. Independent research, sometimes called third party research, is conducted by experts who have nothing to gain or lose from the results of the study. This research is intended to provide strict objectivity.
In the case of ingredient testing, for example, any research conducted by the manufacturers of ingredient XYZ—who have invested time, money and advertising dollars in the product—couldn’t be objective. An independent group, such as the Cosmetic Ingredient Review (CIR), is by definition one whose primary concern is to assess the safety of ingredients used in cosmetics in an open, unbiased, expert manner, and to publish the results in open, peer-reviewed scientific literature.
Quantitative research. Quantitative research addresses qualities that can be measured or quantified. These measures represent facts, not opinion. If the CIR were to test ingredient XYZ on a quantitative scale, its concerns might include if the ingredient meets or exceeds the national standards established for cosmetic safety or if ingredient XYZ contains substances in amounts higher than what is considered safe for consumers.
Qualitative research. Qualitative research is concerned with more subjective aspects, such as the quality of a product or ingredient, and collects opinions and descriptions from subjects exposed to a particular ingredient, product or treatment. Results may be reported as testimonials. For example, “Ingredient XYZ made my skin softer,” or “Ingredient XYZ caused redness and a rash on my skin.”
Sample size. Sample size refers to the number of people or items involved in doing research in a particular trial. In quantitative research, multiple samples of ingredient XYZ should be tested. Ideally, random sampling would be used. This means samples are tested at random on many different subjects.
In qualitative testing, a large number of subjects should be exposed to the ingredient, product or treatment. For example, ingredient XYZ should be tested on different skin types and ages—not just a few people displaying a specific skin type, condition or non-condition.