Neo-Synalar Modified 48 Hour Patch Test

Overview

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.

Full Title of Study: “A Modified 48 Hour Patch Test of Neo-Synalar Cream, Sodium Lauryl Sulfate (Positive Control) and Saline (Negative Control)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2014

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.

Interventions

  • 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: 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: 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Noah Rosenberg, MD
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Noah Rosenberg, MD, Chief Medical Officer – Medimetriks Pharmaceuticals, Inc
  • Overall Official(s)
    • Michael Caswell, Ph.D, Principal Investigator, Consumer Product Testing Corporation

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