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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.
Details
| Lead sponsor | Noah Rosenberg, MD |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 206 |
| Start date | 2014-06 |
| Completion | 2014-06 |
Conditions
- Allergy
Interventions
- Neo-Synalar Cream
- Sodium Lauryl Sulfate Aqueous Solution (0.40%)
- Saline
Primary outcomes
- Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS) — 48, 96 and 168 Hours
ESS is measured at 48, 96 and 168 hours post-application of study material. The Erythemal Scoring Scale (ESS) is defined as a 6 point scale (0-4). "0"= no visible erythema; "0.5"= slight, barely perceptible erythema; "1"= mild erythema; "2"= moderate erythema; "3"= marked erythema; "4"= severe erythema. An ESS score of 1 or greater that persists or worsens from one visit to the next is defined as pre-existing sensitization.
Countries
United States