Neo-Synalar Modified 48 Hour Patch Test
Information source: Medimetriks Pharmaceuticals, Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergy
Intervention: Neo-Synalar Cream (Drug); Sodium Lauryl Sulfate Aqueous Solution (0.40%) (Other); Saline (Other)
Phase: Phase 4
Status: Completed
Sponsored by: Noah Rosenberg, MD Official(s) and/or principal investigator(s): Michael Caswell, Ph.D, Principal Investigator, Affiliation: Consumer Product Testing Corporation
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.
Clinical Details
Official title: A Modified 48 Hour Patch Test of Neo-Synalar Cream, Sodium Lauryl Sulfate (Positive Control) and Saline (Negative Control)
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 79 Years.
Gender(s): Both.
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).
Locations and Contacts
Michael Caswell PhD., CCRC,CCRA, Fairfield, New Jersey 07004, United States
Additional Information
Starting date: June 2014
Last updated: June 19, 2014
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