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Completed

NCT Number: NCT02168478

Neo-Synalar Modified 48 Hour Patch Test

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.

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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Michael Caswell PhD., CCRC,CCRA

Fairfield, New Jersey, 07004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Neo-Synalar Cream

Drug

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 names: NS 0.5%(0.35% neomycin base)/ FA 0.025% Cream

Sodium Lauryl Sulfate Aqueous Solution (0.40%)

Other

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 names: SLS

Saline

Other

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Noah Rosenberg, MD

Industry

Registry information

Official study title

A Modified 48 Hour Patch Test of Neo-Synalar Cream, Sodium Lauryl Sulfate (Positive Control) and Saline (Negative Control)

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 20, 2014
Registry last updated
Dec 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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