Clinical trial NCT04531813: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypersensitivity
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-08-31
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Cumulative Irritation Total (CIT) Score
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fairfield
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: