24週間の男性における男性型脱毛症の治療 (MINOX)
男性のアンドロゲン性脱毛症の治療のための新しい医薬品形態であるミノキシジル 5% の有効性と安全性を 24 週間評価するための無作為化二重盲検並行群間試験
A prospective, randomized, double-blind, single-center, placebo-Controlled, parallel-group study to evaluate the efficacy and safety of a new pharmaceutical form Minoxidil 5% in men after 24 weeks of treatment.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
調査の概要
詳細な説明
Participants will be randomized at a 2: 1 ratio to receive new pharmaceutical form Minoxidil 5% and placebo, respectively. Through this method, it is possible to obtain more information about the effectiveness of investigational product.
The primary objective of the MINOX study is to demonstrate the superiority of a new topical 5% pharmaceutical form of minoxidil (experimental drug) in treating men with androgenetic alopecia (Hamilton-Norwood scale IIIv, IV or V) compared to placebo when administered for 180 days.
Secondary objectives: 1- To evaluate the efficacy of a new topical 5% minoxidil pharmaceutical form in the treatment of men with androgenetic alopecia, compared to placebo, by means of terminal strand density in the target area, evaluated 30 (±3), 60(±3), 90(±3) and 135(±3) days after the beginning of treatment.
2- To evaluate the efficacy of a new topical 5% pharmaceutical form of minoxidil in the treatment of men with androgenetic alopecia, compared to placebo, by means of the percentage of anagen strands in the target area, evaluated 30(±3), 60(±3), 90(±3), 135(±3) and 180(±3) days after the start of treatment.
3- Evaluate the efficacy of a new topical 5% pharmaceutical form of minoxidil in the treatment of men with androgenetic alopecia, compared to placebo, by means of the average length of hair strands in the target area, evaluated 30(±3), 60(±3), 90(±3), 135(±3) and 180(±3) days after the start of treatment.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
São Paulo
-
São Paulo、São Paulo、ブラジル、06696-000
- Eurofarma Laboratorios S.A
-
-
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:
- Age between 18 and 65 years;
- Male pattern baldness identified according the Norwood Hamilton scale: stage IIIv vertex, stage IV, or stage V;
- Terminal hair density equal to or less than 220 hairs/cm2 measured with the Trichoscale Al;
- Subjects who are willing and able to comply with all requirements of the study for the intended period;
- Subjects who give their consent to the study after thoroughly clarification and who personally signed and dated the informed consent document has been informed of all pertinent aspects of the trial;
Exclusion Criteria:
- Current or 6 months dated back use of:
- Minoxidil, finasteride, or any 5 alpha-reductase inhibitor;
- Medications that can potentiate Hypertrichosis, such as: cyclosporine, phenytoin, psolarenes, oral glucocorticoids (except inhalers), lithium, phenothiazinics
- Medications with anti-androgenic properties, such as: cyproterone, spironolactone, ketoconazole, flutamide, bicalutamide.
- Any anabolic steroid ;
- Current or 8 weeks dated back use of herbal products such as saw palmetto;
- Isotretinoin for at least 12 months;
- Current or 2 weeks dated back use of dietary or vitamin supplements;
- Subjects who had a dignosis of malignant disease in the alopecia area in the period of 05 years;
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：処理
- 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 |
|---|---|
|
プラセボコンパレーター：Minoxidil´s Placebo
The recommended dosage is 1 ml of the solution twice a day (morning and evening). |
1 mL of solution twice a day. |
|
実験的：Topical Minoxidil 5%
The recommended dosage is 1 ml of the solution twice a day (morning and evening). |
Apply 1 mL of solution twice a day. |
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 |
|---|---|---|
|
Absolute change in terminal thread density in the target area determined 180 (±3) days after the start of treatment compared to baseline density.
時間枠：24 weeks
|
The density of terminal hairs will be evaluated by phototrichogram (FotoFinder leviacam® and Trichoscale Al® Dermatoscope), with the baseline density resulting from the images captured on the VR and VR+2 days visits and the final density resulting from the images captured on the V5 and V5+2 days visits. Terminal wires will be classified as those with diameter greater than or equal to 30 um. |
24 weeks
|
協力者と研究者
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 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- EF171
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
米国FDA規制機器製品の研究
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。