Neo-Synalar Modified 48 Hour Patch Test
- Conditions
- Allergy
- Interventions
- Registration Number
- NCT02168478
- Lead Sponsor
- Noah Rosenberg, MD
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 206
- 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 .
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patch Test Group Neo-Synalar Cream 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. Patch Test Group Saline 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. Patch Test Group Sodium Lauryl Sulfate Aqueous Solution (0.40%) 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.
- Primary Outcome Measures
Name Time Method Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS) 48, 96 and 168 Hours 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Michael Caswell PhD., CCRC,CCRA
🇺🇸Fairfield, New Jersey, United States