Study to Determine Skin Irritation Potential of an Antifungal Cream Containing Trolamine After Repeated Skin Application (Cumulative Irritation Patch Test)

In this study researchers want to study the potential skin reaction after repeated application of an antifungal cream containing trolamine. The study plans to enroll about 32 healthy female or male participants with the age 18 - 79 years. Researchers will apply on the skin of the upper back between the shoulder blades of the study participants three different patches to cover a small amount of the antifungal cream or 0.3% solution of sodium lauryl sulfate, which is known to cause skin irritation (so called positive control). A third patch will cover a skin area without any product (so called negative control). Participants will return daily to the study center to have new patches containing the test products applied on the same skin area of the back, excluding weekends, for 21 days of continuous skin contact. At each visit the skin will be investigated by the researchers for redness, dryness and other reactions to learn about the skin reaction after repeated application.

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Key information

Conditions

Hypersensitivity Immune System Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fairfield, New Jersey, 07004, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants must have been aged 18 to 79 years, inclusive.
Participants must have understood and executed an Informed Consent Form (ICF).
Participants (if female) must have been willing to take a urine pregnancy test prior to the initiation and at the completion of the trial.
Participants must have been capable of understanding and following directions.
Participants must have been considered reliable.

Exclusion criteria

Participants who were in ill health or taking medication, other than birth control, which could have influenced the purpose, integrity or outcome of the trial.
Participants who had any visible skin disease that might have been confused with a skin reaction to the test material.
Participants who were participating in another clinical trial at this facility or any other facility.
Participants who were using topical or systemic steroids or antihistamines for at least 7 days prior to trial initiation and during the duration of the trial.
Participants who had a history of adverse reaction to adhesive tape, cosmetics, over-the-counter (OTC) drugs or other personal care products.
Participants judged by the principal investigator (PI) to be inappropriate for the trial.
Female participants who were pregnant as evidenced by a positive urine pregnancy test, planning to become pregnant, or nursing during the course of the trial.

Treatment and study plan

Butenafine HCl 1% (BAY1896425)

Drug

Approximately 0.2 g of cream containing butenafine HCl 1% daily (excluding weekends) was applied to the absorbent pad portion of a semi-occlusive dressing, which was then applied to the skin test site. The total dose applied to each participant completing the trial was 3 g.

Other names: Antifungal Cream V61-044 containing Trolamine

Positive Control-Sodium lauryl sulfate (SLS)

Drug

Approximately 0.2 mL of 0.3% solution of sodium lauryl sulfate was applied to the absorbent pad portion of a semi-occlusive dressing, which was then applied to the Positive Control test site.

Negative Control

Other

A blank patch was applied to the Negative Control test site.

Primary outcomes

Cumulative Irritation Total (CIT) Score

Time frame: 21 days

Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: 0 = No visible erythema; 0.5 = Slight, barely perceptible erythema; 1 = Mild erythema; 2 = Moderate erythema; 3 = Marked erythema; 4 = Severe erythema. The Cumulative Irritation Total is generated by totaling the Erythema Scoring Scale scores of the Investigational Product for each subject completing the trial and then adding those totals. Data is being reported for all the 30 participants as a group.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

HT201307-Cumulative Irritation Patch Test (21 Day)

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Aug 31, 2020
Registry last updated: Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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