Neo-Synalar Modified 48 Hour Patch Test
Condition: Allergy
Intervention: Neo-Synalar Cream; Sodium Lauryl Sulfate Aqueous Solution (0.40%); Saline
Intervention description: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.; Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.; Saline is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.
Intervention MeSH terms: Neomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Neo-Synalar; Patch Test; Sodium lauryl sulfate; Saline; Presensitization

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.
    

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).