E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subject who was successfully treated for his/her papulo-pustular rosacea in the initial study (Galderma Study: Eudract N°: 2006-001999-20/RD.03.SPR.40027) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
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 |
The objective of this exploratory 6-month treatment-free follow-up study is to evaluate relapses in patients who were successfully treated in an initial Dose-range study (RD.03.SPR.40027) with CD5024 cream or its vehicle or metronidazole 0.75% cream (Rozex®). |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female subject, at least 18 years old, whose papulo-pustular rosacea was successfully treated (score 0 or 1, grade “clear” or “almost clear” on a 5-point scale, called Investigator Global Assessment Scale 2) in the initial study (RD.03.SPR.40027) and who will be willing to participate in this study, meeting specific inclusion and exclusion criteria. |
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E.4 | Principal exclusion criteria |
1. The subject is planning to be enrolled in an investigational drug or device study during the study
2. The subject is willing to take one of the following treatment which might have an impact in the evaluation of the relapses (eg. subject requesting a maintenance therapy) a. Topically applied to the face: astringents or abrasives, antibiotics i.e. metronidazole or macrolides, anti-rosacea drugs (e.g. azelaic acid…), immunomodulators, corticosteroids, retinoids, antiparasitics;
b. systemic: antibiotics (i.e. cyclines, macrolides, metronidazole), corticosteroids, ivermectin and others antiparasitics, retinoids, corticosteroid with prolonged activity ;
c. Others: Laser or IPL (Intense pulsed light) treatment, telangiectases electrocoagulation, dermabrasion/peeling
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E.5 End points |
E.5.1 | Primary end point(s) |
- Time to relapse according to three definitions of the relapse - Relapse rate according to three definitions of the relapse - Change from baseline in erythema score - Change from baseline in telangiectasis score - Change form baseline in Investigator Global Assessment Score 1 (IGA 1) |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
Evaluate relapes of clinical lesions after a dose range study |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Investigator will be blinded with respect to the treatment received by the subject in initial study |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Groups will be compared according to treatments received in the initial study |
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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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 13 |
E.8.9.2 | In all countries concerned by the trial days | 0 |