Back to resultsStudy to Determine Skin Irritation Potential of an Antifungal Cream Containing Trolamine After Repeated Skin Application (Cumulative Irritation Patch Test)
Primary Purpose
Hypersensitivity
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Butenafine HCl 1% (BAY1896425)
Positive Control-Sodium lauryl sulfate (SLS)
Negative Control
Sponsored by
About this trial
This is an interventional treatment trial for Hypersensitivity
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cumulative Irritation Test
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04531813
Brief Title
Study to Determine Skin Irritation Potential of an Antifungal Cream Containing Trolamine After Repeated Skin Application (Cumulative Irritation Patch Test)
Official Title
HT201307-Cumulative Irritation Patch Test (21 Day)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 10, 2013 (Actual)
Primary Completion Date
July 1, 2013 (Actual)
Study Completion Date
July 1, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cumulative Irritation Test
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Butenafine HCl 1% (BAY1896425)
Other Intervention Name(s)
Antifungal Cream V61-044 containing Trolamine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Positive Control-Sodium lauryl sulfate (SLS)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Negative Control
Intervention Description
A blank patch was applied to the Negative Control test site.
Primary Outcome Measure Information:
Title
Cumulative Irritation Total (CIT) Score
Description
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.
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Fairfield
State/Province
New Jersey
ZIP/Postal Code
07004
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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.
Links:
URL
https://clinicaltrials.bayer.com/
Description
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Study to Determine Skin Irritation Potential of an Antifungal Cream Containing Trolamine After Repeated Skin Application (Cumulative Irritation Patch Test)
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