Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test)
2020年10月27日 更新者：Bayer
HT201321- Repeated Insult Patch Test With Modified Challenge
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.
調査の概要
研究の種類
介入
入学 (実際)
225
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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New Jersey
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Fairfield、New Jersey、アメリカ、07004
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～79年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Repeated Insult Patch Test
During the Induction Phase, participants received 0.2 g Butenafine HCl 1% covered by an occlusive patch on the upper back skin test site three times a week for a total of 9 applications.
Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system.
After 14 days of Rest Phase, on the first day of Challenge Phase, participants received same procedure on original Induction Phase test site and on a virgin test site.
The patches were removed and the sites scored 48 hours after application and scored again at 96 hours after application.
The test sites were evaluated using the Induction Phase scoring system.
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Approximately 0.2 g of cream containing butenafine HCl 1% were applied to the upper back skin.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Enrolled Subjects
時間枠：After 4 weeks
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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.
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After 4 weeks
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Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Enrolled Subjects
時間枠：After 6 weeks
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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.
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After 6 weeks
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Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Evaluable Subjects
時間枠：After 4 weeks
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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.
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After 4 weeks
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Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Evaluable Subjects
時間枠：After 6 weeks
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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.
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After 6 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2013年9月9日
一次修了 (実際)
2013年10月18日
研究の完了 (実際)
2013年10月18日
試験登録日
最初に提出
2020年8月26日
QC基準を満たした最初の提出物
2020年8月26日
最初の投稿 (実際)
2020年8月28日
学習記録の更新
投稿された最後の更新 (実際)
2020年11月17日
QC基準を満たした最後の更新が送信されました
2020年10月27日
最終確認日
2020年10月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
IPD プランの説明
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing".
This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research.
This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research.
Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
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