Development of Allergic Antibody to an Enzyme in a Body Lotion: Results of an 18-Month Clinical Study

Figures & data

Number of individuals with IgE antibody to Y217L BPN′ enzyme

				Serology (RAST Class)
Time	No. SPT (+)	Subject no.	Weal(flare) (mm)	Pre	Post
Baseline	0/1091
Month 3	0/1000
Month 6	1/965	92167	3(4)/3(8)	0	2
	(0.1%)
Month 9	0/928
Month 12	0/903
Month 15	2/878	92152	4(10)/4(15)	0	2
	(0.23%)	82018	5(25)/5(26)	0	2
Month 18	0/863
Month 21	1/49	81103	5(20)/4(15)	0	2
(post)	(2%)

* Arm 1 and arm 2; SPT conducted with 50 μg/ml enzyme.

Follow-up SPT with Y217L BPN′ and proteases and amylases in detergent products

Enzyme SPT reagent	No. 92167	No. 92152	No. 82018	No. 81103
B. amyloliquifaciens (protease)
500 ug/ml	4(19)/4(21)	−**	4(15)/−	5(32)/6(24)
50 ug/ml	2(12)/−	3(23)/−	3(10)/−	6(17)/3(16)
B. licheniformis (protease)
500 ug/ml	3(22)/3(15)	0(0)	0(0)	0(0)
50 ug/ml	0(4)/−
B. lentus (protease)
500 ug/ml	0(0)	0(0)	0(0)	0(0)
B. amyloliquifaciens (amylase)
500 ug/ml	0(0)	0(0)	0(0)	0(0)
B. licheniformis (amylase)
500 ug/ml	0(0)	0(0)	0(0)	0(0)

* Weal (flare) in mm on arm 1 and/or arm 2.

** Arm not tested due to protocol deviation.

1 The percent change in TEWL (measured gH₂O/m²/h) from enzyme treated skin sites (-◯-) and nil-enzyme treated skin sites (-•-) and the percent change in capacitance (measured in au units) from enzyme-treated skin sites (-⋄-) over time. There was less fluctuation of TEWL measurements from enzyme treated skin as compared to control skin sites. There was an increase in capacitance measurements over time.

2 The percent of test subjects with visually assessed mild (-•-), moderate (-█-), or severe (-◯-) skin grades over time. There was an increase in the percent of subjects with mild skin grades (∼ 8%) and a decrease in the percent of subjects with moderate to severe skin grades during the first 3–6 months of the study. These changes were not statistically significant.