Neo-Synalar Modified 48 Hour Patch Test
| Status: | Completed |
|---|---|
| Conditions: | Allergy, Allergy |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - 79 |
| Updated: | 4/21/2016 |
| Start Date: | June 2014 |
| End Date: | June 2014 |
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.
(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.
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.
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).
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