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Services >> Safety Clinical Trials >> Acnegenicity Comedogenicity Follicular Biopsy

Acnegenicity/Comedogenicity

Global expertise, personal touch

Insights into our Acnegenicity/Comedogenicity Study

Overview

Our Acnegenicity/Comedogenicity Study empowers you to substantiate this claim with scientific evidence, ensuring consumer confidence and market success. This study, often paired with a Safety-in-Use assessment, also evaluates the potential for skin irritation.

Reliable Results

  • We leverage a minimum of 30 subjects (increased numbers enhance reliability) over a 4–6-week period with daily (or more frequent) facial applications.
  • Ideal for pre-market assessment and consumer safety claims

Streamlined Study Process

Our streamlined study provides an evidence-backed and proven process. The process includes:

  1. Product Submission: Provide individual units sufficient for each subject's needs.
  2. Skin Health Assessment: Our team meticulously evaluates facial skin health across diverse skin types during the initial visit.
  3. Lesion Count & Product Application: Dermatologists or trained staff conduct acne lesion counts on suitable subjects (normal to oily or acne-prone skin). They then receive the test product, usage instructions, and a daily diary for recording applications.
  4. Final Evaluation: Following the study period, subjects return for a final assessment, including a repeat acne lesion count and recording.
  5. Optional Consumer Feedback: An optional final questionnaire gathers valuable insights on the consumer's experience with the product.

Clear and Actionable Reporting

Upon completion, we analyze changes in lesion counts to support your non-comedogenic and non-acnegenic claims. If no significant increase in non-inflammatory or total lesions occurs, the evidence strengthens your claims. We provide unaudited results verbally or in writing, with a detailed final report within 2 weeks post study.

Conducting a Follicular Biopsy Study

Overview

At Eurofins CRL, we offer a unique solution for assessing the potential of ingredients to clog pores – the Follicular Biopsy Study. This innovative method, conducted on the upper backs of subjects, provides valuable insights that are distinct from traditional Acnegenicity/Comedogenicity studies. Our panels consist of 15 or 18 subjects, ensuring a thorough assessment with a minimum of 12 or 15 subjects completing the study.

Rigorous Study Procedure for Comprehensive Evaluation

The study procedure involves applying test products to occlusive patches on subjects' upper backs every Monday, Wednesday, and Friday for four weeks. For potentially irritating products, sponsor approval is required to use semi-occlusive patches. During each visit, our team removes old patches and checks the skin for any signs of irritation before applying new patches to ensure sustained skin exposure.

At the end of the study period, researchers perform follicular biopsies at each site to examine for the presence of microcomedones or small skin blemishes.

Reliable Interpretation and Reporting

Our team analyzes the microcomedone/follicle ratio for each test product and compares it to a negative control to determine the results. Products are deemed non-comedogenic if their ratios are not significantly greater than the negative control. Validation is further achieved by comparing the negative control site to a positive control site.

Actionable Insights for Product Development

Following rigorous statistical analysis, you'll receive prompt access to the results. Our comprehensive final report includes irritation scores, microcomedone/follicle ratios, and applied statistical analysis, providing you with valuable insights to guide your product's development and substantiate marketing claims.

Unlock the secrets of pore-clogging potential with Eurofins CRL's Follicular Biopsy Study. Partner with our team of experts today and gain a competitive edge through accurate and reliable data.