check_circleStudy Completed

Hypersensitivity

Bayer Identifier:

18156

ClinicalTrials.gov Identifier:

NCT04531540

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to determine skin irritation and/or sensitization potential of an antifungal cream containing Trolamine (Repeated Insult Patch Test)

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - 79 Years
  • - 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.
  • - 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.

Trial summary

Enrollment Goal
225
Trial Dates
September 2013 - October 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

  • Irritation response evaluation according to Erythema Scoring Scale during Induction Phase - All enrolled subjects
    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: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
    date_rangeTime Frame:
    After 4 weeks
  • Allergic reaction evaluation according to Erythema Scoring Scale during Challenge Phase - All enrolled subjects
    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: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
    date_rangeTime Frame:
    After 6 weeks
  • Irritation response evaluation according to Erythema Scoring Scale during Induction Phase - All evaluable subjects
    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: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
    date_rangeTime Frame:
    After 4 weeks
  • Allergic reaction evaluation according to Erythema Scoring Scale during Challenge Phase - All evaluable subjects
    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: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
    date_rangeTime Frame:
    After 6 weeks

Trial design

HT201321- Repeated Insult Patch Test with Modified Challenge
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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