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URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis (MICKAEL)

2026年9月14日 更新者：CEN Biotech

PERFORMANCE AND SAFETY OF THE MEDICAL DEVICE "URGO ONGLES ABIMES PAR MYCOSES ET TRAUMATISMES" IN THE TREATMENT OF MILD TO MODERATE DISTAL ONYCHOMYCOSIS: AN OPEN STUDY (MICKAEL)

The objective of this clinical study is to evaluate the performance of URGO MICKAEL Filmogel as a topical treatment for mild to moderate onychomycosis

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Patients with a positive dermatophyte/fungal culture from a toenail sample are eligible for inclusion in the study. Patients apply the device under investigation daily to the affected toenails.

Patients are followed for up to 6 months, or until a negative fungal culture is obtained and the clinical appearance of the treated nails indicates resolution and significant improvement of the onychomycosis.

Four visits will be organized at the investigation site under the supervision of the principal investigator:

  • Baseline / Inclusion visit (V0)
  • 3 follow-up visits (V1, V2 and final V3) carried out 1, 3 and 6 months after the initiation of the treatment.

研究の種類

介入

入学 (推定)

54

段階

  • 適用できない

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。

研究連絡先

研究場所

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  1. With 1 or 2 big toenail(s) damaged, which the clinical appearance of at least one great toenail is suggestive of onychomycosis.
  2. Big toenails with distal mild to moderate subungual onychomycosis (OSI Score < 16, no proximal or lunula involvement, and ≤50% nail involvement).
  3. Able to understand and comply with protocol requirements and instructions, including applying the device.
  4. Affiliated to a French Health insurance scheme.
  5. Having signed an informed consent.

8. With 1 or 2 big toenail(s) damaged by onychomycosis confirmed by positive culture for dermatophytes / fungi on at least one big toenail.

Exclusion Criteria:

  1. Having a known allergy or hypersensitivity or contraindication to one of the constituents of UOA.
  2. The toenail(s) to be included in the study present(s) severe onychomycosis (which should be treated by systemic drug), or is/are unstructured, has/have severe microcracking or severe onycholysis, or the nail(s) or nail(s) contour has/have severe lesions.
  3. Having used any systemic antifungal treatment in the last 6 months before Baseline/pre-inclusion visit V0.
  4. Having used any topical antifungal treatment in the last 3 months before Baseline/pre-inclusion visit V0.
  5. With cutaneous pathology on studied zone (onychogryphosis, congenital ungual deformation, toe deformation or of the foot, hallux valgus, hallux rigidus, hallux extensus, toe claws or other pathologies than onychomycosis like angioma, dermatitis…).
  6. With a condition or receiving medication which, according to the investigator's judgment, could jeopardize the safety of the subject.
  7. Suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, lichen planus, immunosuppressive pathology, chronic venous insufficiency, Peripheral Arterial Obstructive Disease, delay, or lack of ungual growth etc.
  8. May not respect the constraints imposed by the protocol.
  9. Enrolled in another clinical trial or being in a period of exclusion from a previous clinical trial.
  10. Woman of childbearing age (except menopausal, hysterectomised, sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant, or condoms).
  11. Person belonging to a population referred to in articles 64 (incapacitated subjects), 65 (minors), 66 (pregnant or breastfeeding women), 67 (persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision) and 68 (patients in emergency) of the MDR.

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
実験的：URGO MICKAEL Filmogel
Local treatment of big toenails with positive culture
デバイス：URGO MICKAEL Filmogel
The device is used daily on 1 or 2 big toenails for up to 6 months The investigator may decide to discontinue treatment at after 1 or 3 months if the studied toenail(s) meet all the following criteria: 1. Negative dermatophyte/fungal culture. 2. Healthy appearance of the studied toenail(s), defined by a score of 0 ("none") for all the following items: onycholysis, nail dystrophy, nail discoloration, and nail thickening.

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
Mycological cure rate evaluated at 6 months
時間枠：180 days

Mycological cure is defined by a negative culture for dermatophytes/fungi from the big toenail under study.

A direct microscopic examination is performed after dissolving and staining the toenail sample using MYCETCOLOR® (Mycol60). The potassium hydroxide (KOH) test indicates the presence or absence of fungal elements. However, it does not provide information on the viability or etiology of any fungal elements detected.

Therefore, the samples are also placed on a suitable culture medium and incubated at a controlled temperature for several days to several weeks. Fungal growth is monitored, and any colonies that appear are identified microscopically to determine the specific fungal species involved.
180 days

二次結果の測定

結果測定
メジャーの説明
時間枠
Mycological cure rate evaluated at 1 month
時間枠：30 days

A direct microscopic examination is performed after dissolving and staining the toenail sample using MYCETCOLOR® (Mycol60). The potassium hydroxide (KOH) test indicates the presence or absence of fungal elements. However, it does not provide information on the viability or etiology of any fungal elements detected.

Therefore, the samples are also placed on a suitable culture medium and incubated at a controlled temperature for several days to several weeks. Fungal growth is monitored, and any colonies that appear are identified microscopically to determine the specific fungal species involved.
30 days
Mycological cure rate evaluated at 3 months
時間枠：90 days

Mycological cure is defined by a negative culture for dermatophytes/fungi from the big toenail under study.

A direct microscopic examination is performed after dissolving and staining the toenail sample using MYCETCOLOR® (Mycol60). The potassium hydroxide (KOH) test indicates the presence or absence of fungal elements. However, it does not provide information on the viability or etiology of any fungal elements detected.

Therefore, the samples are also placed on a suitable culture medium and incubated at a controlled temperature for several days to several weeks. Fungal growth is monitored, and any colonies that appear are identified microscopically to determine the specific fungal species involved.
90 days
Change from baseline in onychomycosis severity at 1 month
時間枠：30 days

The severity of onychomycosis, assessed by a trained investigator, and using the global score of Onychomycosis Severity Index or OSI.

It provides a numerical score ranging from 0 (normal nail) to 35 (total dystrophy with full matrix involvement), based on three components:

  • Nail Involvement Area (1-5 points): percentage of the nail plate affected by onychomycosis estimated visually (0, [1-10], [11-25], [26-50], [51-75], [76-100]) and translated into a score;
  • Disease proximity to matrix from distal edge (<1/4, [1/4 to 1/2], [1/2 to 3/4], >3/4). The area score is then multiplied based on the location of the infection (x1 if the involvement is distal and/or lateral only; x2 if the involvement extends proximally and/or reaches the nail matrix);
  • Additional Points for Nail Features: +10 points if presence of hyperkeratosis ≥2 mm or dermatophytoma (i.e., longitudinal streak or patch).
30 days
Change from baseline in onychomycosis severity at 3 months
時間枠：90 days

The severity of onychomycosis, assessed by a trained investigator, and using the global score of Onychomycosis Severity Index or OSI.

It provides a numerical score ranging from 0 (normal nail) to 35 (total dystrophy with full matrix involvement), based on three components:

  • Nail Involvement Area (1-5 points): percentage of the nail plate affected by onychomycosis estimated visually (0, [1-10], [11-25], [26-50], [51-75], [76-100]) and translated into a score;
  • Disease proximity to matrix from distal edge (<1/4, [1/4 to 1/2], [1/2 to 3/4], >3/4). The area score is then multiplied based on the location of the infection (x1 if the involvement is distal and/or lateral only; x2 if the involvement extends proximally and/or reaches the nail matrix);
  • Additional Points for Nail Features: +10 points if presence of hyperkeratosis ≥2 mm or dermatophytoma (i.e., longitudinal streak or patch).
90 days
Change from baseline in onychomycosis severity at 6 months
時間枠：180 days

The severity of onychomycosis, assessed by a trained investigator, and using the global score of Onychomycosis Severity Index or OSI.

It provides a numerical score ranging from 0 (normal nail) to 35 (total dystrophy with full matrix involvement), based on three components:

  • Nail Involvement Area (1-5 points): percentage of the nail plate affected by onychomycosis estimated visually (0, [1-10], [11-25], [26-50], [51-75], [76-100]) and translated into a score;
  • Disease proximity to matrix from distal edge (<1/4, [1/4 to 1/2], [1/2 to 3/4], >3/4). The area score is then multiplied based on the location of the infection (x1 if the involvement is distal and/or lateral only; x2 if the involvement extends proximally and/or reaches the nail matrix);
  • Additional Points for Nail Features: +10 points if presence of hyperkeratosis ≥2 mm or dermatophytoma (i.e., longitudinal streak or patch).
180 days
Change from baseline in toenail condition at 1 month
時間枠：30 days
Onycholysis, nail dystrophy, nail discoloration, and nail thickening assessed using the following scores: 0 = none, 1 = very slight, 2 = slight, 3 = moderate, and 4 = severe.
30 days
Change from baseline in toenail condition at 3 months
時間枠：90 days
Onycholysis, nail dystrophy, nail discoloration, and nail thickening assessed using the following scores: 0 = none, 1 = very slight, 2 = slight, 3 = moderate, and 4 = severe.
90 days
Change from baseline in toenail condition at 6 months
時間枠：180 days
Onycholysis, nail dystrophy, nail discoloration, and nail thickening assessed using the following scores: 0 = none, 1 = very slight, 2 = slight, 3 = moderate, and 4 = severe.
180 days
Clear toenail area in toenail with negative culture at 6 months
時間枠：180 days
Percentage of clear toenail area in toenail with negative culture.
180 days
Investigator's opinion on treatment efficacy at 1 month
時間枠：30 days
Opinion is addressed using the Investigator's Global Impression of change with 7 modalities from "very much worse" to "very much improved", to respond to: What is your opinion regarding the improvement of the treated toenail?
30 days
Investigator's opinion on treatment efficacy at 3 months
時間枠：90 days
Opinion is addressed using the Investigator's Global Impression of change with 7 modalities from "very much worse" to "very much improved", to respond to: What is your opinion regarding the improvement of the treated toenail?
90 days
Investigator's opinion on treatment efficacy at 6 months
時間枠：180 days
Opinion is addressed using the Investigator's Global Impression of change with 7 modalities from "very much worse" to "very much improved", to respond to: What is your opinion regarding the improvement of the treated toenail?
180 days
Investigator's opinion on toenail appearance at 1 month
時間枠：30 days
Opinion is addressed using the Investigator's Global Impression of change with 7 modalities from "very much worse" to "very much improved", to respond to: What is your opinion regarding the appearance of the treated toenail?
30 days
Investigator's opinion on toenail appearance at 3 months
時間枠：90 days
Opinion is addressed using the Investigator's Global Impression of change with 7 modalities from "very much worse" to "very much improved", to respond to: What is your opinion regarding the appearance of the treated toenail?
90 days
Investigator's opinion on toenail appearance at 6 months
時間枠：180 days
Opinion is addressed using the Investigator's Global Impression of change with 7 modalities from "very much worse" to "very much improved", to respond to: What is your opinion regarding the appearance of the treated toenail?
180 days
Patient's satisfaction with the treatment effectiveness at 1 month
時間枠：30 days
Opinion is addressed using questions with 5 modalities from "Not at all satisfied" to "Very satisfied", to respond to: What is your opinion regarding the appearance of the treated toenail?
30 days
Patient's satisfaction with the treatment effectiveness at 3 months
時間枠：90 days
Opinion is addressed using questions with 5 modalities from "Not at all satisfied" to "Very satisfied", to respond to: What is your opinion regarding the appearance of the treated toenail?
90 days
Patient's satisfaction with the treatment effectiveness at 6 months
時間枠：180 days
Opinion is addressed using questions with 5 modalities from "Not at all satisfied" to "Very satisfied", to respond to: What is your opinion regarding the appearance of the treated toenail?
180 days

その他の成果指標

結果測定
メジャーの説明
時間枠
Occurrence of device deficiencies at 6 months
時間枠：180 days
Percentage of patients reporting device deficiencies defined as any inadequacy in the identity, quality, durability, reliability, inadequacy of information provided by the manufacturer, including labeling.
180 days
Occurrence of adverse events at 6 months
時間枠：180 days
Adverse events are coded using the MedDRA dictionary. Adverse events are classified according to their seriousness, their relationship to the device, and for adverse device effects, whether they are expected or unexpected.
180 days
Improvement in quality of life at 6 months
時間枠：180 days

Quality of life is assessed using a questionnaire composed of the following three scales:

Nail Distress Scale: Subjects indicate how often they experience nail-related distress during the past week using a 5-point scale (4 = strongly disagree; 3 = disagree; 2 = neither agree nor disagree; 1 = agree; 0 = strongly agree).

Nail Symptoms Scale: Subjects indicate how concerned they have been about their nail condition during the past week using a 5-point scale (4 = not at all; 3 = a little; 2 = somewhat; 1 = very; 0 = extremely).

Physical Scale: Subjects indicate how their nail condition interferes with their activities during the past week using a 5-point scale (4 = never; 3 = rarely; 2 = sometimes; 1 = often; 0 = always).

The raw scores each scale are added together to produce a total raw score which is converted to a score ranging from 0 (worst) to 100 (best), with higher scores indicating better outcomes.
180 days

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

CEN Biotech

協力者

URGO RECHERCHE INNOVATION & DEVELOPPEMENT

捜査官

  • 主任研究者：Carole Perrin, MD、CEN

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)

2026年1月28日

一次修了 (推定)

2026年12月31日

研究の完了 (推定)

2027年6月30日

試験登録日

最初に提出

2026年9月14日

QC基準を満たした最初の提出物

2026年9月14日

最初の投稿 (実際)

2026年9月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月18日

QC基準を満たした最後の更新が送信されました

2026年9月14日

最終確認日

2026年9月1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

  • C1763
  • IDRCB no. 2025-A02049-40 (その他の識別子：ANSM)

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?

いいえ

IPD プランの説明

The informed consent obtained from participants does not include provisions for sharing individual participant data with external researchers

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

いいえ

米国FDA規制機器製品の研究

いいえ

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。

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