Active Ingredient Product Testing and Clinical Claim Support

Active Ingredients and Drug Concentration Claim Support Studies

(201) 331-9300

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Published by our sponsorsSee case studies

Mineral sunscreen whitening study, NCT05565625 ↗

Skin hydration and health study ↗

18-week hyperpigmentation study, NCT07136766 ↗

12-week eye cream study, NCT05807620 ↗

OTC Ingredient And Cosmetic Actives Pilot Studies

Over The Counter (OTC) products and active ingredients should be tested only at an FDA Registered Facility, and Validated Claim Support is proud to have registered with the FDA before we opened our doors.

FDA current Registration Search: https://www.accessdata.fda.gov/scripts/cder/drls/default.cfm

Validating Your Next Active Ingredient Claims, Clinically

If you are using regulated active ingredients, it is imperative that you follow posted rules and guidelines, and it is often recommended that you go above and beyond basic cosmetic safety testing practices.

Active ingredients such as Retinol are known to have some irritating properties, and irritants must be treated with an additional standard of care.

Common Over The Counter Ingredient claim support studies include:

Acne and Lesion Testing
Certain Hyperpigmentation Ingredients
Dandruff Control
Retinol based Anti-Aging Claims
Hair Growth Studies
Anti-perspirant Testing

Institutional Review Board for Drug Product Testing

We generally recommend that studies involving known irritants or OTC level ingredients are submitted to an Institutional Review Board (IRB), also known in some places as Ethics Committee. IRB review allows us to get a full third-party safety review for the product and its intended use.

VCS maintains a relationship with Allendale IRB, and we are happy to work with any other third-party IRB that a sponsor may prefer. Please note it may take additional time to complete an IRB Submission with a new Institutional Review Board.

Outside of OTC Ingredients, VCS also recommends an external IRB whenever there are known primary irritants, or a medical device/drug delivery system is used, or whenever an at-risk panel is required for testing.

Allendale IRB (Regulatory and Technical Associates) for Cosmetic Studies

Regulatory and Technical Associates, Inc. (RTA) is a toxicology, medical device development and preclinical drug, and regulatory affairs consulting company that specializes in a wide range of development activities. Our consultants are Board Certified in safety, regulatory affairs, toxicology and have many years of experience in toxicology, preclinical drug & medical device development, and regulatory affairs. We work with domestic and international clients and provide superior consulting services.

VCS focuses our attention on our clients’ needs in the petroleum, chemical, consumer product, food, cosmetic, medical device, and pharmaceutical industries. We’re known as a leading expert in women’s reproductive health & are registered with the FDA as a US Agent.

Our toxicology, preclinical drug & medical device development, and regulatory activities focus on the safety evaluation of new and established products. RTA has the required experience in preclinical drug development, toxicology, & regulatory affairs to help our client’s address the product development regulatory issues & safety that directly impact their ability to bring their products to market.

RTA routinely makes preparations for regulatory submissions for the FDA and other worldwide regulatory agencies. These include GRAS determinations, Food Additive Petitions, PMAs, 510(k)s, IDEs, CTDs, NDAs, IND Annual Reports, and INDs.

Preliminary safety testing and skincare irritation testing protects the consumer, ensures that you meet local and international regulatory requirements, and allows you to enter competitive distribution channels with hard requirements in place.

Drug & medical device product development is a difficult, time-consuming, and labor-intensive process. RTA gives you the consultation, support, and experience in toxicology, medical device and preclinical drug development, and regulatory affairs necessary to bring your products to market.

Crow’s feet wrinkle tracing at baseline and T4

Pilot Studies and Preliminary Efficacy for Topical Drugs

For preliminary active ingredient studies, sometimes sponsors are still “honing in” on the most optimal active concentration for consumer use. In these cases, VCS often recommends a pilot study on 5-10 subjects where we will be able to review the different concentrations directly in comparison to one another.

This isn’t always possible for facial application or long-term products, however, it is a very powerful and cost-effective way to begin your journey into claims support, and it can provide a robust set of comparison-related information.

For final claim support studies, VCS recommends completing the study with a minimum of 30 subjects for statistical significance. This number is also the widely accepted industry standard.

Validated can also provide Clinical Photography on a small subset of subjects to help demonstrate novel Active ingredient Efficacy.

Clinical photography

Before & After Photography: Custom Teaneck NJ Studio

Clinically Validated, High Resolution Before and After Images and Analysis Over Time. Validated Claim Support uses high-resolution clinical photography to document how a product performs over a treatment timeline or product usage cycle.

See our before and after photography Get a quote See the gallery

BaselineWeek 2

Redness reduction: 44% less redness from baseline to week 2. The lower circle shows the average skin color in the treated area. Drag to compare.

Before and after case studies

Hair Growth Efficacy And Clinical Density Improvement →

Hair Density And Hair Growth Clinical Imaging Side Profile →

Acne lesion, baseline compared with result

Full Face Acne Reduction Lesions With Analysis →

Dry Scalp And Dandruff Improvement Clinical Study Photo →

Anti-Aging, Wrinkle Reduction And Clinical Claim Support Imaging →

Full Face Before And After Anti-Aging And Fine Line Reduction →

Pore Size Reduction Clinical Photograph →

Blemish redness, baseline compared with day 3

High Resolution Redness Reduction →

Expert Clinical Grading

Trained graders score visible change

Supports claims like “Clinically proven to reduce the appearance of fine lines and wrinkles”

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Biomarkers and Microbiome

Tape strips, swabs and collections

Supports claims like “Microbiome friendly” and “Won’t disrupt the skin’s natural microbiome”

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Biophysical Instrumentation

Hydration, TEWL, elasticity, color

Supports claims like “Hydrates by up to 87% in as little as one use”

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Peer-Reviewed Writing

Clinical and scientific publications

Scientifically validated study summaries for publication in peer-reviewed medical journals

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Before and After Photography

Controlled, reproducible clinical imaging

Supports claims like “Up to a 44% reduction in redness in as little as 2 weeks”

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Consumer Perception

Panelist questionnaires and self-assessment

Supports claims such as “97% of women agreed their skin felt smoother and more supple”

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Where to next

Keep exploring

Back toOver The Counter Claims RelatedDandruff Testing Claims RelatedHair Growth Studies Plan your budgetPricing

Start a Conversation About Your Product Study

Tell us about your product, your intended claims, and your timeline. Our business development team will review your needs and follow up with a customized proposal, typically within one business day. There is no cost for the initial consultation or study design review.

Get a quote Call (201) 331-9300

FAQ

Active Ingredient Testing: frequently asked questions

Where should OTC active ingredients be tested?

Over-the-counter products and active ingredients should be tested only at an FDA registered facility. Validated Claim Support registered with the FDA before it opened its doors, and its current registration can be checked in the FDA's drug establishment registration search.

Which active ingredient studies does VCS commonly run?

Common over-the-counter ingredient studies at Validated Claim Support include acne and lesion testing, certain hyperpigmentation ingredients, dandruff control, retinol-based anti-aging claims, hair growth studies and antiperspirant testing.

Do active ingredient studies need IRB review?

Validated Claim Support generally recommends submitting studies with known irritants or OTC-level ingredients to an Institutional Review Board, or ethics committee, for a full third-party safety review. VCS also recommends an external IRB for medical devices or drug delivery systems and for at-risk panels, and handles all documentation and submission.

Which IRBs does VCS work with?

Validated Claim Support maintains relationships with Allendale IRB, and is happy to work with any other third-party IRB a sponsor prefers, although a submission to a new IRB may take additional time.

How should I test different concentrations of an active ingredient?

When a sponsor is still honing in on the best active concentration, Validated Claim Support often recommends a pilot study on 5 to 10 subjects to compare concentrations directly. This is not always possible for facial or long-term products, but it is a powerful, cost-effective way to begin claims support.

How many subjects does a final active ingredient claim study need?

For final claim support studies, Validated Claim Support recommends completing the study with a minimum of 30 subjects for statistical significance, which is also the widely accepted industry standard. Clinical photography can be added on a small subset of subjects to help demonstrate active ingredient efficacy.

Why do ingredients like retinol need extra care in testing?

Active ingredients such as retinol are known to have some irritating properties, and irritants must be treated with an additional standard of care. If you use regulated or monograph-level actives, follow all posted rules and guidelines, and consider going beyond basic cosmetic safety testing.