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

Bayer

Status and phase: Completed; Phase 3

Conditions: Hypersensitivity

Treatments: Drug: Positive Control-Sodium lauryl sulfate (SLS); Other: Negative Control; Drug: Butenafine HCl 1% (BAY1896425)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04531813

18153

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Cumulative Irritation Test

Experimental group

Description:

Participants received butenafine HCl 1% cream on the skin test site, 0.3% solution of sodium lauryl sulfate on the skin Positive Control test site, and a blank patch on the skin Negative Control test site daily (excluding weekends) for 21 days, or 15 applications.

Treatment:

Other: Negative Control

Drug: Butenafine HCl 1% (BAY1896425)

Drug: Positive Control-Sodium lauryl sulfate (SLS)