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

Lead Sponsor

Bayer

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

Yes

•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.