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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


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.


Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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