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).