Phase 4
Completed N=206
Neo-Synalar Modified 48 Hour Patch Test
Source: ClinicalTrials.gov NCT02168478 ↗Enrolled (actual)
206
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS) — 0 percentage of patients w allergic rxn
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS) |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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 .
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT02168478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.