CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 206 enrolled
Drug / intervention
Neo-Synalar Cream +2 moredrug
Likely dose
Neo-Synalar Cream 0.2 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02168478
NCT02168478Phase 4Completed
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A Modified 48 Hour Patch Test of Neo-Synalar Cream, Sodium Lauryl Sulfate (Positive Control) and Saline (Negative Control)

Noah Rosenberg, MD·interventional·Posted Jun 20, 2014·Updated Dec 11, 2015

In Brief

A Phase 4 clinical trial evaluating Neo-Synalar Cream, Sodium Lauryl Sulfate Aqueous Solution (0.40%), and 1 other intervention for Allergy. Completed, enrolled 206 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergy
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 20, 2014
Enrollment StartJun 1, 2014
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 12.0 years ago

Interventions

Neo-Synalar Creamdrug

Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.

Sodium Lauryl Sulfate Aqueous Solution (0.40%)other

Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.

Salineother

Saline is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.