Acne, Pores, Oil Control And Comedone Claims

Clinical Reduction in Acne and Oiliness, Quantified and Analyzed

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Mild acne at baseline and clearer skin at T1

OTC Testing for Acne Products, and Clinical Studies for Adjacent non-OTC Categories

At Validated Claim Support, we can conduct a wide range of Acne Claim Substantiation Studies designed to help differentiate your products. Whether you’re talking about quantified acne reduction, lesion counting, or lesion healing, VCS can help you substantiate your Acne claims.

While more common in young adults and adolescents, pimples, acne, and generally troubled skin can be a major source of self-consciousness and frustration.

It’s more important than ever to differentiate your acne products for the global consumer, and we can help you do so with a number of different study designs.

Mentioning “Acne” or “Pimples” generally categorizes you into the drug product and Over the Counter realm, so it is imperative that you support your products as such. We recommend referencing these terms if your product has an approved Acne ingredient such as Salicylic Acid or Benzoyl Peroxide.

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.

Sample Acne Claims:

Reduces the Appearance of Acne Lesions
Helps Eliminate Pimples in as Little as One Use
Stops or Reduces Breakouts
Reduces Inflammation and Redness

Additional Considerations for OTC Drug Testing Claims

It’s more important than ever to differentiate your acne products for the global consumer, and there are quite a few methods to do so.

See the acne lesion case in the gallery →

Non-Drug Related Acne Claims

For products that work on oil or sebum, there are some effective techniques that don’t cross into the drug realm. It’s possible to discuss a wide range of claims that are related to Acne, but don’t directly put you into a highly regulated product category. It’s very important that even considering using these “adjacent claims” is discussed with a legal representative and your regulatory team, as there are no hard rules about why someone will receive a warning letter from the FDA.

Sample Cosmetic Claims That Don’t Necessarily Force OTC Monography

Reduces the Appearance of Redness
Oil Control
Non-Comedogenic
Won’t Clog Pores
Reduces the Appearance of Large Pores
Reduces the Appearance of Troubled Skin
Helps promote clearer skin

Acne and Oil Control Claim Support Techniques:

Sebumeter/Instrumentation
Acne Lesion Scoring and Expert Grading
Redness Reduction
Color Analysis
Before and After Photography

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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What panelists are asked

At each visit, panelists rate statements like these on a five-point scale. Each statement is written to match a claim you want to make, and the result is reported as the percentage of panelists who agreed (Strongly Agree plus Agree).

Strongly agreeAgreeNeitherDisagreeStrongly disagree

My skin looks clearer.
My breakouts have been reduced.
My pores look smaller.
My skin looks less oily and shiny.
This product is gentle enough for daily use.

Example statements from VCS questionnaire templates. Final wording is agreed with you in the protocol.

Where to next

Keep exploring

Back toOver The Counter Claims RelatedActive Ingredient Testing RelatedDandruff Testing Claims 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

Acne Testing Claims: frequently asked questions

What acne claims can Validated Claim Support substantiate?

Validated Claim Support runs acne claim substantiation studies covering quantified acne reduction, lesion counting and lesion healing. Sample claims include "Reduces the appearance of acne lesions," "Helps eliminate pimples in as little as one use," "Stops or reduces breakouts" and "Reduces inflammation and redness."

Does using the word "acne" make my product a drug?

Generally, yes. Mentioning "acne" or "pimples" usually places a product in the drug and over-the-counter category, so it needs to be supported as such. Validated Claim Support recommends using these terms only if your product contains an approved acne ingredient such as salicylic acid or benzoyl peroxide.

Can I make acne-related claims without entering the OTC drug category?

For products that work on oil or sebum, some claims are related to acne but do not necessarily force OTC monograph requirements, such as "Reduces the appearance of redness," "Oil control," "Non-comedogenic," "Won't clog pores," "Reduces the appearance of large pores," "Reduces the appearance of troubled skin" and "Helps promote clearer skin." Discuss these with your legal and regulatory team first.

How does VCS test acne and oil control products?

Validated Claim Support supports acne and oil control claims with Sebumeter instrumentation, acne lesion scoring and expert grading, redness reduction, color analysis and before and after photography.

Should an acne product have safety testing as well?

Yes. Preliminary safety testing and skincare irritation testing protect the consumer, help you meet local and international regulatory requirements, and allow you to enter competitive distribution channels that have hard requirements in place.