Safety and Irritation

Patch Testing, Safety In Use, Hypoallergenic Claim Support, Sensitive Skin, HRIPT and Ocular Testing

VCS can help provide you with the assurance that your product won’t cause irritation, clog pores, or cause allergenic/systemic reactions in a sample population ranging from 20-100 test subjects.

Consumer safety is broken down into 2 main categories:

• Patch Testing
• Consumer in Use Safety

Amazon.com Marketplace Safety Documentation and Compliance

Recently Amazon has changed its marketplace requirements to include more stringent safety testing and patch testing requirements. Amazon also now requires a Certificate of Analysis for all products in the personal care space, and if you’re unfamiliar with clinical testing and claim support it can be quite a lot to digest.

Our team of experts will be happy to walk you through Amazon’s safety guidelines, ensuring that your products are compliant, that consumers are safe, and that your products are back up on the marketplace as quickly as possible if you get one of the dreaded “takedown” letters as you await your safety compliance data.

Patch Testing and Safety Assays

Patch testing represents a visual assessment of the capacity of a product to induce redness, scaling, or inflammation when applied directly to the skin.

It is generally split up into short term or Primary Irritation and long-term Sensitizing or Cumulative irritation practices.

Repeat Insult Patch Testing (RIPT)

An industry standard test for discerning both the immediate irritation and the long term, systemic or allergenic reaction potential of a given topical product or treatment. Useful for supporting claims such as “non-sensitizing,” “non-irritating,” “not a primary irritant,” and “Dermatologist Approved.”

Additional Medical Professional review is also available with RIPT, and it is possible to support secondary claims such as “Pediatrician Tested.”

Jordan and King, Schlanski, Kligman methods are available.

Safe for Sensitive Skin

The traditional RIPT panel can be modified to include a panel that has self-perceived sensitive skin. This is often recommended for certain leave-on products, products designed for use around the eye area, or products designed for use in intimate areas.

Sensitive skin claims can also be supported in use as an add on with medical review and a percentage of users with self-perceived or qualified sensitive skin.

48 Hour Patch

Simplified, single application irritation testing for topically applied products. Does not include a measure of sensitization.

These tests often represent a place holder or benchmark irritancy test, and 48 hour results can be made available via report from any standard RIPT for an additional fee.

Cumulative Irritation

A 14 or 21 day protocol to detect the outcome of a continuous product application over an extended period of time.

This method is slightly more aggressive than HRIPT, as products are applied with no breaks, and often this method is recommended for “Leave on” products. It also commonly helps support the claim “Safe for Daily Use.”

20 subject panel

Comedogenicity

Comedones or black heads can be formed when products disrupt the skin’s natural ability to pass waste and normal biproducts.

The claim “non-comedogenic” is both widely used and sought after by consumers who have oil prone skin or suffer from blackheads and acne.

The test is performed on the back, with product applications followed by a follicular biopsy and a comparison to an untreated site. Comedones removed are counted under a microscope and the sites are scored and compared.

This test represents a hybrid safety/efficacy test because the claim is also demonstrative of a form of product efficacy.

ROAT Repeat Open Application Testing

A skin test is used to confirm or rule out the presence of allergic contact dermatitis, often used after initial patch testing for secondary confirmation.

Safety in Use Testing

Aside from basic irritation and safety, there is a wide range of secondary claims that can be supported through “Safety in Use” or User Trials as well.

Safety in use provides both a measure of irritation as well as the gateway to a number of highly sought-after marketing claims, and as such it is a multifaceted approach that can boost sales and protect the consumer.

Claims Supported

• Safe for Use Around the Sensitive Eye Area
• Ophthalmologically Tested
• Gynecologist Tested
• Safe for Contact Lens Wearers
• No Tears
• Won’t Irritate the Eyes
• Clinically Tested
• Safe for Intimate Use
• Condom Compatible

Ophthalmological Testing – Non-Instillation Versus Direct Instillation

For products designed for use around the sensitive eye area, secondary safety is often recommended under the care of a medically trained professional.

We generally recommend that some form of In Vitro ocular irritation is conducted prior to direct irritation and eye area studies, and we can happily recommend a laboratory to conduct this work as well.

VCS maintains a number of agreements with consulting doctors including Ophthalmologists, and their experience can help ensure that products are both safe while also providing claims that boost consumer awareness.

Indirect Instillation under Ophthalmological Supervision

A study in healthy male and female users with a minimum of 50% contact lens wearers.

An Ophthalmologist conducts onsite study assessments under slit lamp to ensure that products do not cause irritation.

This study helps to support claims such as “Ophthalmologist tested/approved” and “Suitable for contact lens wearers”.

Direct Installation

A study in healthy male &  female subjects, to evaluate the comparative eye irritation potential of 1 test article plus control.

In this instance, the product is diluted and installed directly into the eyes via dropper. Scores are compared to baseline to determine product-oriented redness and irritation.

Panelists also fill out a perception questionnaire about sting and irritation as well.

Intimate Area Products (Gynecologist Tested)

These “In Use” tests provide a secondary practical assessment of continuous application/use, however they are more akin to “product efficacy” and “claims” studies alongside the safety. They also often involve Gynecologist assessments and examinations onsite, and the products are used as intended.

Length of use ranges from 2 weeks on, and usually these studies require a review of additional preliminary safety data.

Recruitment can involve various parameters including sexually active users, users of personal entertainment devices, condom users, etc. in order to support a wide range of real world applicable use possibilities

These tests are often done to boost brand awareness for prestige or premium products once sales, pipelines, and brand recognition is in place due to the underlying cost, and they are not directly recognized by most regulatory authorities.

Anti-Inflammatory and Counter Irritation

Redness, irritation, and scar reduction studies also fall under the blanket of “safety in use.” Once again, these studies provide an approach to documenting and supporting changes that consumers look for while ensuring that products are safe for human use.

Induced Irritation Reduction

Up to 6 sites outlined on volar forearm plus untreated control site.

Induction of inflammation on all skin sites by either:

• UV (4x MED)
• SLS (0.75% patch for 24-hours)
• Friction (super-fine sandpaper – 360-600 grit)

Open-application of products with expert erythema grading of sites prior to application of products throughout the study.

ROAT Repeat Open Application Testing

A skin test is used to confirm or rule out the presence of allergic contact dermatitis, often used after initial patch testing for secondary confirmation.

These tests can be conducted on the forearm, the inner arm, the lower leg, the inner arm, or the back depending on the nature of the product. They can provide a slightly more real world “in use” test than standardized patch testing, however they do not as involve quite as rigorous of a routine.

Anti-Inflammatory and Counter Irritation

Multiple sites outlined on volar forearm plus untreated control site.

Induction of inflammation on all skin sites by either Ultraviolet Dose (2-3x MED), known primary irritant (SLS or similar), or mechanical friction (super-fine sandpaper).

Includes Open Application conductions along with expert erythemal grading of sites prior to application of products and throughout the study.

Color profile for age spots, dark spots, and hyperpigmentation is common in both beauty and OTC drug-level applications. With our proprietary photography techniques we can shoot spots on the face or the body, and follow treatments along to see how skin-tone is evened overtime, how the intensity of the hyperpigmentation is reduced, or the overall area of the spots diminishes. Clinical Photography and Analysis can be done stand-alone, or we can pair the techniques as part of a larger clinical evaluation comprising Expert Grading, User Subjective Feedback, or secondary instrumental assessments of color profiling and L* values.

Inflammation and Redness are two of the most commonplace signs of stress in the skin. VCS can conduct induced redness and irritation studies and compare an untreated site to your product to see if your formulation can help to reduce the symptoms more quickly. Redness and Irritation are generally considered OTC level claims, and as an FDA Registered and Inspected Laboratory you can trust our team to handle your drug level visual claim support. We can induce a wide range of irritation for treatment, including but not limited to UV/sunburn, known primary irritant/positive control (we can also extend this out for poison oak/poison ivy), Acne Lesion inflammation, Dandruff, Psoriasis, and Eczema, and a wide range of other secondary claims as well.