Neo-Synalar Modified 48 Hour Patch Test

Noah Rosenberg, MD

Status and phase: Completed; Phase 4

Conditions: Allergy

Treatments: Drug: Neo-Synalar Cream; Other: Saline; Other: Sodium Lauryl Sulfate Aqueous Solution (0.40%)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02168478

MTWC01-001

Details and patient eligibility

About

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 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.

Enrollment: 206 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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206 participants in 1 patient group

Patch Test Group

Experimental group

Description:

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.

Treatment:

Other: Saline

Other: Sodium Lauryl Sulfate Aqueous Solution (0.40%)

Drug: Neo-Synalar Cream