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Completed

NCT Number: NCT04531540

Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test)

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.

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Key information

Conditions

Hypersensitivity Immune System Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fairfield, New Jersey, 07004, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Butenafine HCl 1% (BAY1896425)

Drug

Approximately 0.2 g of cream containing butenafine HCl 1% were applied to the upper back skin.

Other names: Antifungal Cream V61-044 containing Trolamine

Primary outcomes

  1. Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Enrolled Subjects

    Time frame: After 4 weeks

    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.

  2. Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Enrolled Subjects

    Time frame: After 6 weeks

    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.

  3. Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Evaluable Subjects

    Time frame: After 4 weeks

    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.

  4. Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Evaluable Subjects

    Time frame: After 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

HT201321- Repeated Insult Patch Test With Modified Challenge

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 28, 2020
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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