Comedogenicity and Acnegenicity
- FDA Registration FEI# 1000151293 as a GMP/GLP/GCP Drug Establishment and Cosmetic Facility.
- DEA Registration# RC0199744 (Analytical Lab) | Schedule I-V license | Remember, Schedules I-II require DEA Form 222 | Registration# RC0171568 (Researcher)
- US EPA/NJ DEP Registration# NJD982726648
- ISO/IEC 17025:2017 Accreditation# 80071
Consumers are more educated about the products they buy today than ever before.
That’s especially true in the world of cosmetics and skincare. Of major concern are products which cause pimples and skin eruptions. This is called “acnegenicity” or “comedogenicity,” and avoiding it is difficult since products composed of similar ingredients can have different effects which can vary by user. Guides for the most knowledgeable consumers say that the only way to be sure is to seek out products that have undergone comedogenic testing by an independent third-party reputable lab.
This is where CPTSM comes in. Our half-century of experience means that we are second to none when it comes to demonstrating that our clients’ products provide what consumers need.
How Skincare Products Can Cause Acne
Acnegenicity and comedogenicity are very similar concepts and most experts use the terms interchangeably to describe the formation of comedones, better known as blackheads and whiteheads. Comedones are skin pores which become clogged with debris. Once formed, they cause inflammation and provide an ideal environment for bacterial infection which results in the redness, swelling, and pain that accompany more severe cases of acne.
Skin pores are the pathways through which oils produced by the skin reach its surface. These oils are called “sebum,” and they play a crucial role in protecting and moisturizing the skin. Too much sebum can clog the pores, and many personal care products can cause the overproduction of sebum. Other products may block pores independently of sebum by adhering to the surface of the skin and the interior of the pores.
Products can also cause comedones by disrupting a process called “keratinization.” When this process proceeds normally, skin cells mature and harden as they rise to the surface and are eventually shed. When this process is disrupted, dead skin cells accumulate near the pore and combine with sebum to clog it.
Three Ways Scientists Identify Pore-Clogging Products
A web search for information about this issue will turn up listings of ingredients that can cause acne. These are based on groundbreaking research by the dermatologist Albert Kligman, who first identified this type of skin issue as “acne cosmetica.” Kligman conducted his research employing a technique called the Rabbit Ear Test, in which test substances were applied to the ears of laboratory animals and their effects monitored. Please note animal testing is not allowed in the EU, California and other jurisdictions.
Even though Kligman conducted his research decades ago, this type of testing is still used. That said, even a good animal model like a rabbit has limited utility when it comes to predicting reactions in humans.
A technique called the Follicular Biopsy Test was developed in the 1980s in order to provide more relevant results for humans. In follicular biopsy testing, a chemical compound is applied to the backs of human volunteers along with positive and negative control substances. After weeks of exposure, samples are collected by applying cyanoacrylate glue to the sites where the skin has been exposed to the test product. These samples are then analyzed to determine whether comedones have formed or acne is present.
This technique offers more reliable results than rabbit testing, however it also has limits. Reactions to chemicals applied to the back don’t always predict reactions which may occur elsewhere on the body—especially on the face.
The gold standard for predicting the acnegenicity of consumer products is the in-use clinical trial. In this type of study, volunteers are asked to use the product for a period of weeks in the manner that the product is intended for use in the targeted consumer population. Before starting, each volunteer’s skin is carefully examined to determine the quantity and severity of comedones which may be present. Volunteers having no comedones at all will be excluded from the study, just as volunteers who are especially resistant to comedone formation will be, since comedogenic effects in them may be missed. After the exposure period is over, subjects are reexamined and any change in the number of comedones or their severity is assessed along with any adverse reactions which may have occurred.
CPTSM understands that the complexity of comedogenicity claims requires that each product be viewed as being ‘unique’ in its own way.
The trials that we design are specific to the situations and needs that our clients present to us. Decades of experience provide us with the ability to create the right study for your product, whatever it is.
Why CPT℠ Relies on “In-Use” Clinical Trials
The FDA does not regulate the use of the terms “non-comedogenic” and “non-acnegenic”, thus there is no standard or official method of testing used to substantiate them.
Rabbit Ear and Follicular Biopsy testing are less expensive and easier to conduct than in-use clinical trials, therefore tempting manufacturers to resort to them. At CPTSM, our decades of experience have shown us that the extra expense and effort required by in-use trials is worth it. In spite of the fact that animal testing historically provided reliable results, many consumers began to avoid products tested in this manner. Also, since most products contain multiple ingredients that can interact in unpredictable ways, the only way to obtain accurate results is to conduct testing in the manner by which the products are intended to be used. The only way to achieve this goal is to employ a carefully designed in-use clinical trial.
How CPTSM Conducts Acnegenicity/ Comedogenicity Trials
CPTSM understands that the complexity of comedogenicity requires that each product be viewed as being ‘unique’ in its own way. The trials that we design are specific to the situations and needs that our clients present to us. Decades of experience provide us with the ability to create the right study for your product, whatever it is.
Proving comedogenicity claims requires a sufficient population of subjects to provide statistical validity. Subjects must have the right characteristics (such as sex or skin type), and they must also be reliable to follow the protocol instructions for 4 weeks or longer—even if that means changing their skincare regimen or avoiding common drugs that might interfere with the evaluation of the product being tested.
CPTSM’s expertise in recruiting motivated panelists allows us to find the right population for any study.
Combining a properly composed test panel with our experienced staff of board-certified dermatologists and our cutting-edge bioinstrumentation capabilities, CPTSM provides unmatched expertise in conducting comedogenicity/acnegenicity in-use trials. Why not contact us today to find out how we can put that expertise to work for you?
