Neo-Synalar Modified 48 Hour Patch Test

NCT02168478 | Completed Phase 4 Results

• 1 other identifier: MTWC01-001
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS)

  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.

  48, 96 and 168 Hours

Study Arms (1)

Patch Test Group

EXPERIMENTAL

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.

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

Interventions

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.

Also known as: NS 0.5%(0.35% neomycin base)/ FA 0.025% Cream

Patch Test Group

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.

Also known as: SLS

Patch Test Group

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.

Patch Test Group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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).

Sponsors & Collaborators

• Noah Rosenberg, MD: lead

Study Sites (1)

Michael Caswell PhD., CCRC,CCRA

Fairfield, New Jersey, 07004, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Noah L. Rosenberg, MD, Chief Medical Officer
• Organization: Medimetriks

Noahrosie@yahoo.com

2019194083

Study Officials

• Michael Caswell, Ph.D

  Consumer Product Testing Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Medical Officer

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 20, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 11, 2015
• Results First Posted: December 11, 2015

Record last verified: 2015-11

Locations

US (1)