Assessing menstrual tampon irritation using the "Behind-The-Knee" test

Area of Science:

• Gynecological health
• Dermatology
• Product safety testing

Background:

• Colposcopy is standard for intravaginal product safety but has limitations.
• Background microtrauma and inability to assess during menstruation affect colposcopy's utility.
• Assessing small inflammatory changes post-use with colposcopy is challenging.

Purpose of the Study:

• To evaluate the Behind-The-Knee (BTK) test as an alternative to colposcopy.
• To assess the BTK test's efficacy in detecting inflammation and dryness from intravaginal products.
• To improve the sensitivity of safety assessments for menstrual products.

Main Methods:

• The Behind-The-Knee (BTK) test involves repeated application of products to the popliteal fossa.
• Concurrent parallel comparisons of experimental and control products were conducted.
• Erythema scoring immediately after product removal in the BTK test was employed.

Main Results:

• BTK test erythema scoring immediately after removal increased detectable inflammation sixfold.
• BTK test results for tampons were comparable to colposcopy after overnight recovery.
• Subclinical inflammation visualized in menstrual pad testing correlated with discomfort and product tolerability.

Conclusions:

• The BTK test is a valuable alternative to colposcopy for assessing inflammation and dryness.
• The BTK test enhances the sensitivity for detecting subtle changes in tissue.
• This method provides greater confidence in the predictive value of product safety assessments.