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Clinical Research
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Xenaderm(TM) Ointment Does Not Induce Contact Sensitization in Repeated Insult Patch Tests in Healthy Subjects First Author: Diane Cooper Authors: D. Cooper and H.B. Slade Two independent studies were carried out to further examine the potential for a refined balsam of Peru (8.7% w/w)Ðcastor oilÐtrypsin formulation (Xenaderm(TM), Healthpoint Ltd., Fort Worth, TX) to induce contact sensitization in healthy volunteers. The first study completed 207 subjects aged 12 to 65 years of age. The second study extended the age range, completing 50 subjects aged 65 to 83 years, using the commercial ointment formulation. In each study, a three week, 9-exposure repeated insult patch test was performed using approximately 0.2 gm of test product per application. Following a two week rest, a challenge exposure was placed for 48 hrs, with skin evaluation performed at 48, 72 and 96 hrs. Barely perceptible erythema was observed during the induction or challenge phase in 36% and 26% of subjects in the two studies, respectively. The product was not considered irritating, and under the conditions of the studies showed no evidence of inducing allergic contact sensitization in human subjects. These findings are consistent with a previous clinical study of similar design. The lack of demonstrable sensitization with this product may be due to the manner in which it is formulated, its concentration, or a refinement of the balsam of Peru component. |
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