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

HT201307-Cumulative Irritation Patch Test (21 Day)

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.

Study Overview

• Status: Completed
• Conditions: Hypersensitivity
• Intervention / Treatment: Drug: Butenafine HCl 1% (BAY1896425); Drug: Positive Control-Sodium lauryl sulfate (SLS); Other: Negative Control

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Fairfield, New Jersey, United States, 07004

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cumulative Irritation Test; 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.

Drug: Butenafine HCl 1% (BAY1896425); 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; Drug: Positive Control-Sodium lauryl sulfate (SLS); 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.; Other: Negative Control; A blank patch was applied to the Negative Control test site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Irritation Total (CIT) Score	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.	21 days

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer Healthcare products.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Anti-Infective Agents; Antifungal Agents; Butenafine
• Other Study ID Numbers: 18153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No