Allergy Clinical Trial
Official title:
A Modified 48 Hour Patch Test of Neo-Synalar Cream, Sodium Lauryl Sulfate (Positive Control) and Saline (Negative Control)
A 48 hour patch test performed in healthy volunteers to determine the presensitization
(pre-existing allergy) of Neo-Synalar (neomycin sulfate 0.5%(0.35% neomycin base),
fluocinolone acetonide 0.025%) Cream . Subjects also receive a positive control (Sodium
Lauryl Sulfate) and a negative control (Saline).
The primary objective of this study is to determine if any subjects exhibit an allergic
reaction which may be indicative of a pre-existing sensitization.
Following approximately 48 hours of continuous skin contact, the patch units and test
material are removed at the testing facility. The test sites are evaluated for a significant
reaction according to the ESS (Erythemal Scoring Scale).
The test sites are also re-evaluated at 96 and 168 hours post-application (for late
reaction) using the ESS.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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