Neo-Synalar Modified 48 Hour Patch Test
Completed · Phase 4
Conditions studied: Allergy
In brief
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.
Key facts
- Study ID
- NCT02168478
- Run by
- Noah Rosenberg, MD
- People needed
- 206
- Starts
- 2014-06-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2015-12-11
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects must be 18 to 79 years inclusive.
- Subjects must be able to understand and execute informed consent.
- Female subjects must produce a negative pregnancy test.
- Subjects must be capable of following directions.
- Subjects must be considered reliable .
You may not qualify if…
- Subjects who are ill of health or taking medication that could influence the purpose, integrity, or outcome of the trial.
- Female subjects who are pregnant.
- Subjects with a history of adverse reactions to cosmetics, OTC (over the counter) drugs or other personal care products.
- Subjects who have used topical or systemic steroids or antihistamines within 7 days prior to trial initiation or plan to use either during the duration of the trial.
- Subjects with known allergy to neomycin, bacitracin, gentamicin, paromomycin, spectinomycin, streptomycin or tobramycin.
- Subjects with known allergy to corticosteroid.
- Subjects with a history of auto-immune disease (e.g. lupus, psoriatic arthritis, rheumatoid arthritis).
Where it is running
- Michael Caswell PhD., CCRC,CCRA — Fairfield, New Jersey, United States
Full record on ClinicalTrials.gov
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