check_circleStudy Completed

Hypersensitivity

Bayer Identifier:

18153

ClinicalTrials.gov Identifier:

NCT04531813

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to determine skin irritation potential of an antifungal cream containing trolamine after repeated skin application (cumulative irritation patch test)

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - 79 Years
  • - 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.
  • - 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 summary

Enrollment Goal
32
Trial Dates
June 2013 - July 2013
Phase
Phase 3
Could I Receive a placebo
No
Products
LOTRIMIN ULTRA (Butenafine HCl, BAY1896425)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Fairfield, 07004, United States

Primary Outcome

  • 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.
    date_rangeTime Frame:
    21 days

Trial design

HT201307-Cumulative Irritation Patch Test (21 Day)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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