Study to Determine Skin Irritation Potential of an Antifungal Cream Containing Trolamine After Repeated Skin Application (Cumulative Irritation Patch Test)
Condition: Hypersensitivity
MeSH terms: Hypersensitivity
Intervention: Butenafine HCl 1% (BAY1896425); Positive Control-Sodium lauryl sulfate (SLS); Negative Control
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.; 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.; A blank patch was applied to the Negative Control test site.
Intervention MeSH terms: Butenafine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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.