Development of a new test for mechanical irritation:behind the knee as a test site

Abstract

The results of these studies indicated that a protocol using the back of the knee as a test site with an exposure regimen of 6-h daily for 4 days, best met the success criteria for an effective test system for evaluating mechanical irritation.

Specific dermatological benefits associated with quantities of lotion transferred to the skin

“…Skin condition is evaluated visually prior to sample application (baseline) and each day after the 6‐hour sample wear. Scoring consists of visual assessment for erythema using a grading scale previously described where “0” is no apparent cutaneous involvement and “4” is moderate‐to‐severe spreading erythema . Scoring for dryness is carried out using a scale of “0”‐“6”, where “0” is no apparent dryness, and “6” is severe cracking and scaling …”

Assessing the Skin Irritation Potential of Facial Tissues

“…In the modified FCAT, the skin is pretreated by the semiocclusive application of diaper material saturated with water prior to repeated wiping with the baby wipes. Recently, the behindthe-knee (BTK) test method to evaluate the potential irritation caused by baby and adult diapers and catamenial products was developed and validated (4,5). We wanted to develop a similar short-term test system for evaluating the potential irritant effects of facial tissues.…”

“…Repeated-measures analysis (scoring points[2][3][4][5][6][7][8][9] Erythema and dryness were assessed as described in the previous table. A repeated-measures analysis was conducted to determine if multiple treatments produced a cumulative response using the least-square means.…”

Can the Behind-the-Knee Clinical Test Be Used to Evaluate the Mechanical and Chemical Irritation Potential for Products Intended for Contact with Mucous Membranes?

“…Recently we developed a behind-the-knee (BTK) clinical test system. This approach is being used to supplement and sometimes to replace more complicated and invasive product use studies in the evaluation of irritation effects [5].…”