Conditions: Allergy
Keywords: Neo-Synalar Patch Test Sodium lauryl sulfate Saline Presensitization
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 206
Healthy volunteers: yes

Brief 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.

Detailed description:
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.

Arms:
arm 1: All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline.

Test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.

Interventions: intervention 1: Neo-Synalar Cream intervention 2: Sodium Lauryl Sulfate Aqueous Solution (0.40%) intervention 3: Saline
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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.

Protocol document: