Clinical trial NCT04531540: Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test)
Official title: HT201321- Repeated Insult Patch Test With Modified Challenge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypersensitivity
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-08-28
Enrollment: 225
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 researcher want to learn more about possible skin reactions such after repeated application of an antifungal cream containing Trolamine. They are especially interested in skin irritations or allergic skin reactions. The study plans to enroll about 225 female or male participants with the age 18 - 79 years. The antifungal test cream will be applied on the back between the shoulder blades of the participants and covered by a special dressing patch. This will be repeated 3 times a week for the first 3 weeks of this study applying the cream on the same area of the back. At each visit the skin will be investigated for redness, dryness and other reactions. After a rest period of two weeks the test cream will be applied on the same skin area as before and on a second new skin area nearby. After 2 and 4 days the two skin areas will again be investigated for redness, dryness and other reactions.


Eligibility criteria: Inclusion Criteria:

* Subjects must have been aged 18 to 79 years, inclusive;
* Female subjects must have produced a negative urine pregnancy test prior to the initiation and also at the completion of the trial;
* Subjects must have been capable of understanding and following directions.

Exclusion Criteria:

* Subjects who were in ill health or taking medication, other than birth control, which could influence the purpose, integrity or outcome of the trial;
* Subjects who had any visible skin disease that might be confused with a skin reaction to the test material;
* Subjects who were participating in another clinical trial at this facility or any other facility;
* Subjects who used topical or systemic steroids or antihistamines for at least 7 days prior to trial initiation and during the duration of the trial;
* Subjects who had a history of adverse reactions to adhesive tape, cosmetics, OTC drugs or other personal care products;
* Subjects judged by the PI to be inappropriate for the trial;
* Female subjects who were pregnant as evidenced by a urine pregnancy test, planning to become pregnant, or nursing during the course of the trial.

Primary outcomes:
measure: Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Enrolled Subjects
timeFrame: After 4 weeks
measure: Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Enrolled Subjects
timeFrame: After 6 weeks
measure: Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Evaluable Subjects
timeFrame: After 4 weeks
measure: Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Evaluable Subjects
timeFrame: After 6 weeks
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: