A Clinical Study to Evaluate the Sensitizing Potential of LEO 43204 Gel
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of LEO 43204 Gel and Gel Vehicle in Healthy Volunteers Using a Repeat Insult Patch Test Design
This is a randomized, single-center, controlled, within-subject comparison study assessing the sensitization potential of the investigational product, LEO 43204 gel under open conditions in healthy volunteers.
LEO 43204 Gel and Vehicle Gel will be applied to adjacent sites on the infrascapular area of the back. Evaluation of dermal reactions at the application sites will be assessed clinically using a visual scale that rates the degree of erythema, edema and other signs of cutaneous irritation.
Following induction, subjects will have a 10 to 14-day Rest Phase, after which they will enter the Challenge Phase, which consists of one 48-hour application to a naive site on the opposite side of the back. Observations at the naive site during Challenge and the patterns of reactivity during the Induction Phase will provide a basis for an interpretation of contact sensitization.
A total of 10 applications will be made over a period of approximately 6-8 weeks.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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New Jersey
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Fair Lawn、New Jersey、アメリカ、07410
- TKL Research Inc.
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events;
- Fitzpatrick skin types I-IV (due to lack of safety data for the investigational product in darker skin types);
- Complete a Medical Screening form as well as a Medical Personal History form;
Exclusion Criteria:
- Have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction;
- Are not willing to refrain from using topical/systemic analgesics for 72 hours prior to and during the study (daily use of 81 mg aspirin is acceptable and occasional use of acetaminophen will be permitted);
- Are using systemic/topical corticosteroids for 3 weeks prior to and during the study, or systemic/topical antihistamines for 72 hours prior to and during the study;
- Are using medication which, in the opinion of the investigative personnel, will interfere with the study results, including anti-inflammatory medications;
- Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions, or similar products on the back during the study;
- Have psoriasis and/or active atopic dermatitis/eczema;
- Have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
研究計画
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:他の
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
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:LEO 43204
LEO 43204 will be applied topically to the skin under open conditions 10 times
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プラセボコンパレーター:LEO 43204 vehicle
LEO 43204 vehicle will be applied topically to the skin under open conditions 10 times
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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 |
時間枠 |
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The determination of dermal sensitization will be based on LSRs and confirmed at a Rechallenge. If recurrence in Rechallenge is equivalent to or more severe than observed at challenge it will be considered indicative of a sensitization reaction.
時間枠:8 weeks
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8 weeks
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
レオ 43204の臨床試験
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LEO Pharma完了