Neo-Synalar Modified 48 Hour Patch Test

Study Overview
=================
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.

Official Title
-----------------
A Modified 48 Hour Patch Test of Neo-Synalar Cream, Sodium Lauryl Sulfate (Positive Control) and Saline (Negative Control)

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Drug: Neo-Synalar Cream
* Other: Sodium Lauryl Sulfate Aqueous Solution (0.40%)
* Other: Saline


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patch Test Group<br>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. | Drug: Neo-Synalar Cream<br>* 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.<br>* Other names: NS 0.5%(0.35% neomycin base)/ FA 0.025% Cream;Other: Sodium Lauryl Sulfate Aqueous Solution (0.40%)<br>* 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.<br>* Other names: SLS;Other: Saline<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS) | ESS is measured at 48, 96 and 168 hours post-application of study material. The Erythemal Scoring Scale (ESS) is defined as a 6 point scale (0-4). 0= no visible erythema; 0.5= slight, barely perceptible erythema; 1= mild erythema; 2= moderate erythema; 3= marked erythema; 4= severe erythema. An ESS score of 1 or greater that persists or worsens from one visit to the next is defined as pre-existing sensitization. | 48, 96 and 168 Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Saline, Neo-Synalar, Patch Test, Sodium lauryl sulfate, Presensitization