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Neo-Synalar Modified 48 Hour Patch Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 17, 2014
First Posted Date  ICMJE June 20, 2014
Results First Submitted Date  ICMJE September 25, 2015
Results First Posted Date  ICMJE December 11, 2015
Last Update Posted Date December 11, 2015
Study Start Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
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. An ESS score of 1 or greater that persists or worsens from one visit to the next is defined as pre-existing sensitization.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neo-Synalar Modified 48 Hour Patch Test
Official Title  ICMJE A Modified 48 Hour Patch Test of Neo-Synalar Cream, Sodium Lauryl Sulfate (Positive Control) and Saline (Negative Control)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Allergy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.

Interventions:
  • Drug: Neo-Synalar Cream
  • Other: Sodium Lauryl Sulfate Aqueous Solution (0.40%)
  • Other: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2015)
206
Original Actual Enrollment  ICMJE
 (submitted: June 19, 2014)
203
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02168478
Other Study ID Numbers  ICMJE MTWC01-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Noah Rosenberg, MD, Medimetriks Pharmaceuticals, Inc
Study Sponsor  ICMJE Noah Rosenberg, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Caswell, Ph.D Consumer Product Testing Corporation
PRS Account Medimetriks Pharmaceuticals, Inc
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP