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