Safety and Efficacy Study of SKX-16 in Participants With Mild to Moderate Distal Subungual Onychomycosis
A Phase 2, Multicenter, Randomized, Double-Blind Study Evaluating the Safety and Efficacy of SKX-16 (Luliconazole 10% Solution) in Participants With Mild to Moderate Distal Subungual Onychomycosis of the Toenails
This is a parallel group, double blind, vehicle-controlled study in which SKX-16 or vehicle (2:1 randomization) is applied once a day for 52 weeks to all affected toenails to participants with mild to moderate distal subungual onychomycosis (DSO) of the toenails involving between 20 to 50% of at least one great toenail at Screening.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Mehria Afzal Patient Recruitment and Site Engagement Specialist
- 電話番号：326 866-575-3111
- メール：mafzal@inderocro.com
研究場所
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California
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Los Angeles、California、アメリカ、900045
- SKX16B01 Clinical Study - Site 105
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コンタクト：
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- 電話番号：866-575-3111
- メール：mafzal@inderocro.com
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San Francisco、California、アメリカ、94115
- SKX16B01 Clinical Study - Site 101
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コンタクト：
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- 電話番号：866-575-3111
- メール：mafzal@inderocro.com
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Florida
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Miami、Florida、アメリカ、11760
- SKX16B01 Clinical Study - Site 104
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コンタクト：
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- 電話番号：866-575-3111
- メール：mafzal@inderocro.com
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Miami、Florida、アメリカ、33126
- SKX16B01 Clinical Study - Site 109
-
コンタクト：
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- 電話番号：866-575-3111
- メール：mafzal@inderocro.com
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-
Texas
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College Station、Texas、アメリカ、77845
- SKX16B01 Clinical Study - Site 111
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コンタクト：
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- 電話番号：866-575-3111
- メール：mafzal@inderocro.com
-
Houston、Texas、アメリカ、77027
- SKX16B01 Clinical Study - Site 119
-
コンタクト：
- Mehria Afzal Pts Recruitment and Site Engagement Specialist, Indero (CRO)
- 電話番号：866-575-3111
- メール：mafzal@inderocro.com
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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:
- Participant is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
- Male or female participant of any race aged 18 to 70 years, inclusive, at the time of consent.
- Participants with a clinical diagnosis of DSO, involving 20%-50% of at least one of the great toenails at screening.
- Participants must have no more than 5 toes with suspected presence of onychomycosis (ie, no more than a total of 5 infected toenails, including ≤3 non-great toenails and up to 2 great toenails) at screening.
- Participant's target great toenail must have no involvement of the lunula (matrix) and have ≥ 4 mm of clear (unaffected) nail distal from the proximal nail fold at screening.
- Clinical judgment supports that the historical growth rate of the target great toenail will permit monthly toenail clipping during the study.
- Participant must be willing and able to comply with all study procedures and must be available for the duration of the study.
Exclusion Criteria:
- Participant is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
- Participant has a history or presence of a skin condition on the feet that, in the opinion of the investigator, would interfere with the study assessments.
- Participant is known to have immune deficiency or is immunocompromised.
- Participant has continuous onychomycosis of the toenail(s) for ≥ 5 consecutive years immediately prior to Screening visit without any intervening period of complete resolution (information obtained from medical chart or participant's physician, or directly from the participant).
- Participant has fingernails with suspected presence of onychomycosis.
- Participant has disease involvement confined exclusively to the lateral edge of the target great toenail.
- Participant has "spike" of onychomycosis extending to eponychium of the target great toenail.
- Participant had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
- Participant has any clinically significant medical condition or physical/laboratory/vital signs abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.
- Participant has a known history of chronic infectious disease (eg, hepatitis B, hepatitis C, or human immunodeficiency virus [HIV]).
- Participant has a known history of diabetes and an HbA1C ≥ 8% at screening.
- Participant has reported to have previously failed a standard course of oral antifungal treatment for onychomycosis.
- Participant received prior laser treatment, photodynamic therapy, or chemical or surgical treatment for onychomycosis within the last 12 months prior to Day 1.
- Participant has used any prescription or OTC topical antifungal therapy for the toenails within 4 weeks prior to Day 1.
- Participant has used systemic antifungal therapies within 6 months prior to Day 1.
- Participant has used any topical medicated treatment applied to the feet within 2 weeks prior to Day 1, including but not limited to, anti-inflammatory medications, topical corticosteroids, or topical immunomodulators.
- Participant is currently receiving an investigational product or device for any indication, or has received one within 4 weeks prior to Day 1 (excluding investigational products in trials pertaining to Exclusion Criterion #32).
- Participant is unwilling to refrain from the use of other prescription or OTC onychomycosis treatments, nail cosmetics on their toenails (including nail lacquers), or pedicures from the screening visit until the end of the study.
- Participant has a known or suspected hypersensitivity or allergy to luliconazole or imidazole compounds or the excipients of the formulation.
- Participant has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Active Arm
SKX-16 (Luliconazole 10% Solution) |
Applied topically once daily for 52 weeks to all affected toenails identified by the investigator, followed by a Week 56 follow-up visit. |
|
プラセボコンパレーター：Vehicle Arm
Vehicle solution that does not contain active ingredients. |
Applied topically once daily for 52 weeks to all affected toenails identified by the investigator, followed by a Week 56 follow-up visit, under the same conditions as the active arm. |
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 |
|---|---|---|
|
Complete Cure at Week 56
時間枠：56 weeks
|
Proportion of participants who achieve Complete Cure of the target toenail at Week 56, as defined by clinical cure (completely clear target great toenail as assessed by the investigator) and mycological cure (negative KOH microscopy and negative culture) |
56 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mycological Cure at Week 56
時間枠：56 weeks
|
Proportion of participants with mycological cure (negative KOH microscopy and negative culture) of the target toenail at Week 56 |
56 weeks
|
|
Clinical Cure at Week 56
時間枠：56 weeks
|
Proportion of participants with clinical cure (completely clear target great toenail as assessed by the investigator) at Week 56 |
56 weeks
|
|
≤5% Affected Nail Area + Mycological Cure at Week 56
時間枠：56 weeks
|
Proportion of participants with ≤ 5% of affected target toenail area and mycological cure of the target toenail at Week 56 |
56 weeks
|
|
<10% Affected Nail Area + Mycological Cure at Week 56
時間枠：56 weeks
|
Proportion of participants with < 10% of affected target toenail area and mycological cure of the target toenail at Week 56 |
56 weeks
|
|
Percent Change in Affected Nail Area
時間枠：Baseline and Week 56
|
Percent change from baseline in percentage of affected target toenail area at Week 56 |
Baseline and Week 56
|
|
Clear Nail Growth at Week 56
時間枠：56 weeks
|
Clear nail growth of the target toenail at Week 56 |
56 weeks
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- SKX16B01
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
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