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Trial record 21 of 61 for:    Neomycin sulfate

Neo-Synalar Modified 48 Hour Patch Test

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ClinicalTrials.gov Identifier: NCT02168478
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : December 11, 2015
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Noah Rosenberg, MD, Medimetriks Pharmaceuticals, Inc

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.


Condition or disease Intervention/treatment Phase
Allergy Drug: Neo-Synalar Cream Other: Sodium Lauryl Sulfate Aqueous Solution (0.40%) Other: Saline Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Modified 48 Hour Patch Test of Neo-Synalar Cream, Sodium Lauryl Sulfate (Positive Control) and Saline (Negative Control)
Study Start Date : June 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patch Test Group

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
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.
Other Name: NS 0.5%(0.35% neomycin base)/ FA 0.025% Cream

Other: Sodium Lauryl Sulfate Aqueous Solution (0.40%)
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.
Other Name: SLS

Other: Saline
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.




Primary Outcome Measures :
  1. Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168478


Locations
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United States, New Jersey
Michael Caswell PhD., CCRC,CCRA
Fairfield, New Jersey, United States, 07004
Sponsors and Collaborators
Noah Rosenberg, MD
Investigators
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Principal Investigator: Michael Caswell, Ph.D Consumer Product Testing Corporation

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Responsible Party: Noah Rosenberg, MD, Chief Medical Officer, Medimetriks Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02168478     History of Changes
Other Study ID Numbers: MTWC01-001
First Posted: June 20, 2014    Key Record Dates
Results First Posted: December 11, 2015
Last Update Posted: December 11, 2015
Last Verified: November 2015

Keywords provided by Noah Rosenberg, MD, Medimetriks Pharmaceuticals, Inc:
Neo-Synalar
Patch Test
Sodium lauryl sulfate
Saline
Presensitization

Additional relevant MeSH terms:
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Neomycin
Fluocinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action