E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pityriasis versicolor / Tinea versicolor |
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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 | 10056227 |
E.1.2 | Term | Pityriasis versicolour |
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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 primary objective of this study is to assess the efficacy and tolerability of five doses of R126638, in comparison to placebo, in the treatment of pityriasis versicolor. |
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E.2.2 | Secondary objectives of the trial |
Complete Cure at Day 28 (Erythema, desquamation and pruritus scores are 0 (none) and KOH microscopy is negative) Mycological response on Days 14 and 28 Investigator’s Global Assessment on Days 14 and 28 Individual Signs and Symptoms on Days 14 and 28 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject has completed an appropriately administered informed consent/assent 2. Subject is at least 18 years of age and of either sex. 3. The subject has a clinical diagnosis of pityriasis (tinea) versicolor with at least mild desquamation present, and confirmation of Malassezia spp. by KOH microscopy. 4. The subject has multiple lesions in at least two of the following anatomic areas: face, neck, arms, chest, abdomen, back, and legs; or, in the investigator’s opinion, at least moderately extensive skin involvement defined as > 15% BSA.
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E.4 | Principal exclusion criteria |
1. Subject has a history of sensitivity to any of the ingredients in the study medication 2. Subject is currently participating in, or has within the 30 days prior to the clinical trial participated in an investigational clinical trial. 3. Subject has used systemic or topical steroids, or topical antifungal therapy, including shampoos with active ingredients against Malassezia spp. or tar shampoos within the previous 30 days. 4. Subject has used systemic antifungal therapy within the previous 60 days. 5. Subject has received medications within the previous 14 days that are known to prolong the QT interval, that are contraindicated during azole treatment, that are known to influence the bioavailability of azoles, or that reduce gastric acidity which interferes with the absorption of some azoles. 6. The subject has an ECG prior to dosing with a QTcB or QTcF interval >450 milliseconds (if male) or >470 milliseconds (if female) as determined by the central ECG lab, or abnormal morphology of the ECG, or clinically serious arrhythmia.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is Effective Treatment at Day 28. Effective Treatment is defined as: • Erythema, desquamation and pruritus scores are 0 (none) OR • Erythema, desquamation and pruritus scores are < 1 (Minimal) if the corresponding score at baseline was 3 or 4 AND • Mycological Cure (negative KOH microscopy).
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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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 | 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 | 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) | No |
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.8.5 | The trial involves multiple Member States | No |
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 | 7 |
E.8.9.1 | In the Member State concerned days | |
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 | 7 |