Exploratory Study of the Cutaneous Penetration of Biodegradable Polymeric Microparticles in Atopic Dermatitis (MicroIskin)
調査の概要
状態
条件
詳細な説明
Current treatments of inflammatory skin disorders such as acne, psoriasis or atopic dermatitis are primarily topical. They have the advantage of allowing the administration of active substances directly to the skin lesions.
However local treatments may have drawbacks (complex application, local and/or systemic side effects...) and cause poor compliance.
The use of drug carriers is viewed as one of the most promising strategies to target and control the release of active substances to various skin sites. Polymeric microparticles have shown to have a better stability and a more sustained release pattern than other types of drug vehicles such as liposomes.
Based on the results obtained in our preclinical experiments, this proof of concept study aims to assess, in patients suffering from atopic dermatitis, if biodegradable polymeric microparticles reach the pilosebaceous follicles of inflamed skin which would in turn serve as a reservoir of active substance.
研究の種類
入学 (実際)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
-
-
-
Besançon、フランス
- Regional University Hospital
-
-
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:
Healthy volunteers:
- Volunteers over 18
- Male volunteers under 65 or women of childbearing age (with a negative pregnancy test obtained at least 3 weeks before inclusion)
- Caucasian volunteers
- Volunteers having never shown any type of skin lesions regardless of its origin especially any allergic skin reactions.
- Volunteers having signed a free and informed consent form
- Volunteers affiliated to a social security system
Patients:
- Patients over 18
- Male patients under 65 or women of childbearing age (with a negative pregnancy test obtained at least 3 weeks before inclusion)
- Caucasian patients
- Acute phase of atopic dermatitis with a SCORAD between 15 and 40
- Patients suffering from atopic dermatitis skin lesions ≥ 1.5 cm² on the inside of the forearm
- Patients having been treated by class II dermocorticoids with a two-week wash-out prior to inclusion
- Patients having signed a free and informed consent form
- Patients affiliated to a social security system
Exclusion Criteria:
- Participants under 18
- Pregnant or Breastfeeding women
- Post-menopausal women
- Patients having skin lesions adjacent to the selected area
- Patients with complications of atopic dermatitis
- SCORAD <15 or >40
- Patients being treated with a topical or a systemic treatment influencing the skin penetration of the microparticles
- Patients allergics to any component of the formulation
- Patients using cosmetic products on their forearms
- Patients planning to expose themselves to the sun
- Patients with a known immune deficiency
- Patients allergic to any product or device used before, during or after the skin biopsy
- Patients suffering from known wound healing disorders
- Patients with known inherited ou acquired hemostasis disorders
- Patients unable to follow the protocol requirements
- Patients currently involved in another clinical trial (or whose participation has ended less than 2 weeks before inclusion)
- Patients who are not affiliated to a social security system
- Patients in an exclusion period following participation in another clinical trial
- Incapacitated adults
- Participants placed under tutorship or curatorship
- Participants under judicial protection
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：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 |
|---|---|
|
実験的：Group of healthy volunteers and group of patients
|
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 |
|---|---|---|
|
Assessment of the penetration beyond the stratum corneum in human skin (fluorochrome contained in the particle will be detected by confocal microscopy)
時間枠：Day 3
|
The fluorochrome contained in the particle will be detected by confocal microscopy to determine whether the particles have reached beyond the stratum corneum |
Day 3
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Assessment of the quantity of fluorescence (assessed by number of pixels on pictures taken with confocal microscopy)
時間枠：Day 3
|
This will be assessed by the number of pixels on pictures taken with confocal microscopy.
It will allow for the comparison between patients/healthy volunteers and the comparison of affected/non-affected area in patients
|
Day 3
|
協力者と研究者
捜査官
- 主任研究者：Philippe HUMBERT、Centre Hospitalier Universitaire de Besancon
研究記録日
主要日程の研究
研究開始 (実際)
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
本研究に関する用語
キーワード
その他の研究ID番号
- API/2012/32
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