E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Papulo Pustular Rosacea |
Папулопустуларна розацея |
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E.1.1.1 | Medical condition in easily understood language |
Papulo Pustular Rosacea |
Папулопустуларна розацея |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039218 |
E.1.2 | Term | Rosacea |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Period A:
To compare efficacy and safety of CD5024 1% cream applied once daily versus metronidazole 0.75% cream applied twice daily in subjects with papulopustular rosacea after 16-week topical treatment.
The study is powered to detect a 10 % superiority of CD5024 1% cream over metronidazole 0.75% cream determined by percent reduction of inflammatory lesions from Baseline.
Period B:
To compare, for subjects initially successfully treated by 16 weeks treatment, CD5024 1% cream versus metronidazole 0.75% cream during a 36-week extension period by assessing:
- The time of first relapse,
- The relapse rate,
- And the number of days free of treatment |
1. Период A:
Да се сравни ефективността и безопасността на CD5024 1% крем, прилаган веднъж дневно, спрямо метронидазол 0,75% крем, прилаган два пъти дневно, при локално лечение на пациенти с папулопустуларна розацея за период от 16седмици .
Проучването е с потенциал да открие 10 % превъзходство на CD5024 1% крем пред метронидазол 0,75% крем, доказано чрез процентно намаление на възпалителните лезии сравнено с първоначалната визита.
2. Период Б:
Да се направи сравнение, при пациентите лекувани успешно първоначално за 16 седмици с CD5024 1% крем спрямо метронидазол 0,75% крем по време на 36-седмичното продължение на проучването, чрез оценка на:
-Времето до първия рецидив,
-Честотата на рецидиви,
-И броят дни без лечение.
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E.2.2 | Secondary objectives of the trial |
Not applicable" |
Неприложимо |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female subjects 18 years of age or older at the Screening Visit,
- Subjects with papulopustular rosacea scored 3 (moderate) or 4 (severe) according to the Investigator Global Assessment (IGA) at Screening and Baseline visits,
- Subjects with at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face at Screening and Baseline visits. |
-Пациенти мъже или жени, навършили 18 години или по-възрастни към момента на скриниращата визита,
-Пациенти с умерена или тежка папулопустуларна розацея (оценка 3 или 4 според скалата за Глобалната оценка на изследователя към момента на скриниращата и първоначалната визити,
-Пациенти с най-малко 15, но не повече от 70 възпалителни лезии (папули и пустули) по лицето към момента на скриниращата и първоначалната визити,
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E.4 | Principal exclusion criteria |
- Subjects with particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, or seborrheic dermatitis and acne at Screening and Baseline visits,
- Subjects with rosacea with more than two nodules on the face at Screening and Baseline visits. |
-Пациенти с проява наспецифични форми на розацея (rosacea conglobata, rosacea fulminans, изолирана пустулоза на брадата) или други лицеви дерматози, които могат да се объркат с папулопустуларна розацея, като например периорален дерматит, фациална пиларна кератоза или себореен дерматит и акне вулгарис към момента на скриниращата и първоначалната визити,
-Пациенти с розацея с повече от два възела на лицето към момента на скриниращата и първоначалната визити,
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline to week 16 |
От начална визита до седмица 16 |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 54 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Russian Federation |
Ukraine |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |