Overview

Neo-Synalar Modified 48 Hour Patch Test

Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Noah Rosenberg, MD
Treatments:
Fluocinolone Acetonide
Neomycin
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).