E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039218 |
E.1.2 | Term | Rosacea |
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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 |
To assess the non-inferiority of a metronidazole 0.75% cream (Rosiced) in comparison to reference therapy (Rozex) in the local treatment of papulopustular rosacea |
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E.2.2 | Secondary objectives of the trial |
- To assess the superiority of Rosiced cream in comparison to its vehicle - To evaluate the safety of Rosicedâ cream in comparison to Rozex cream |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· Men or Women aged 18 years and over; · Patients with papulopustular rosacea (stage II according to the ‘National Rosacea Society Expert Committee’ classification) requiring topical treatment alone; · Patients with 8 to 30 inflammatory lesions (papules and pustules); · Written informed consent obtained from the patient; · If required by National regulations, patients must be registered with health social security or health insurance; · Patients willing to attend the planned study visits at the investigational centre and to comply with all trial requirements.
For women of childbearing potential: · Urine pregnancy test negative at inclusion; · Use of efficient method of contraception (oral contraception, intra-uterine device, tubal ligature) for at least 2 months before inclusion, during all the study and until 1 month after the end of the study. |
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E.4 | Principal exclusion criteria |
Related to the pathology: · Other types of rosacea; · Skin diseases or underlying conditions that may interfere with the rosacea evaluation or require topical and/or systemic treatments.
Related to rosacea treatment: · Topical treatment of rosacea (e.g. azelaic acid, benzoyl peroxide, metronidazole) within 4 weeks before the inclusion visit; · Systemic treatment of rosacea (e.g. cyclins) within 4 weeks before the inclusion visit; · Cosmetic management of rosacea within 2 weeks before the inclusion visit; · Laser therapy of rosacea within 2 weeks before the inclusion visit.
Related to other treatments: · Topical treatment (e.g. retinoids, antibiotics, steroids, azelaic acid, topical calcineurin inhibitors) of the face within 2 weeks before the inclusion visit; · Systemic steroids and/or antibiotics (e.g. cyclins, macrolids, metronidazole) within 4 weeks before the inclusion visit; · Oral Isotretinoin within 3 months before the inclusion visit. · Oral ivermectin within 3 months before the inclusion visit.
Related to patient : · Known sensitivity to any of study drug ingredient(s); · History of major medical/psychiatric illness or surgery which, in the judgment of the investigator, may interfere with study implementation and/or study parameter assessment(s); · Patients who are not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent; · Patients who have forfeited their freedom by administrative or legal decision or who are under guardianship; · According to National regulations, patients hospitalised in a medical or a social center for another reason than biomedical research.
For women of childbearing potential: · Women who are pregnant or planning a pregnancy during the course of study; · Women not using effective contraception; · Breast-feeding women. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement of inflammatory lesions (papules and pustules) count from D0 to wk12 (D84) and from D0 to wk6(D42). |
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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 | Yes |
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 | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.1.4 | Double blind | No |
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 | Yes |
E.8.2.3 | Other | No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
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 | Information not present in EudraCT |
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 |
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E.8.7 | Trial has a data monitoring committee | No |
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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Last visit of the last patient. |
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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 | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 7 |