Neo-Synalar Modified 48 Hour Patch Test

NCT ID: NCT02168478

Last Updated: 2015-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-06-30

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.

Conditions

Allergy

Keywords

Neo-Synalar; Patch Test; Sodium lauryl sulfate; Saline; Presensitization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Neo-Synalar Cream

Intervention Type: 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.

Sodium Lauryl Sulfate Aqueous Solution (0.40%)

Intervention Type: 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.

Saline

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

NS 0.5%(0.35% neomycin base)/ FA 0.025% Cream; SLS

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Noah Rosenberg, MD

INDUSTRY

Sponsor Role: lead

Responsible Party

Noah Rosenberg, MD

Chief Medical Officer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Caswell, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Consumer Product Testing Corporation

Locations

Michael Caswell PhD., CCRC,CCRA

Fairfield, New Jersey, United States

Countries

United States

Other Identifiers

MTWC01-001

Identifier Type: -

Identifier Source: org_study_id