Cumulative Irritation Evaluations

Cumulative Irritation Evaluations

BioScience Laboratories Skin Technology Center performs the Human Repeat Insult Patch Test (RIPT) for cumulative skin irritation in accordance with the FDA/CDER Guidance for Industry, Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products, December 1999.

Study Requirements:

The guidance requires that the product and its vehicle (product without active principle) be tested, along with a high-irritancy control material, sodium lauryl sulfate (SLS; also known as sodium dodecyl sulfate, or SDS), and a low-irritancy control material, 0.9% saline, by applying small quantities to a single site on the skin of the upper back of 30 or more subjects each day for 21 days and occlusively patching each site while the applied material is wet.  

If the testing is for an ANDA in which bioequivalency data are necessary, a fifth material, the so-called “Innovator patch,” is also tested, and the outcome for the test material is compared with that for the Innovator (i.e., the product already approved to market to which the test material claims equivalency).  

The degree of irritation at the sites is scored by a trained evaluator (BSLI personnel and/or a licensed dermatologist, depending on circumstances) for degree of erythema/vesiculation/peripheral extension each day prior to reapplication of the materials.  For purposes of FDA approval, the test material must display some level of irritation, but less than that produced by the positive control (SLS).  That is, if the product shows no irritating properties, the FDA will declare the results inconclusive.

A problem with the FDA requirements for RIPT testing is that test materials must be occlusively patched while still wet.  Many products used for preoperative and/or preinjection preparation that are quite irritating when patched wet are much less so if allowed to dry prior to patching, and under normal circumstances of use, these products would virtually never be occlusively patched while wet.  Even so, the FDA requires that they be tested wet.  A common solution to this dilemma is to add a limb to the study in which the product is permitted to dry for some specified period prior to patching the site of its application.  Note that the RIPT can be performed in combination with the Modified Draize Test, described as follows.


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