E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Flushing related to erythematotelangiectatic or papulopustular rosacea |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10016825 |
E.1.2 | Term | Flushing |
E.1.2 | System Organ Class | 10047065 - Vascular 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 |
− to demonstrate objectively that CD07805/47 0.5% gel is able to prevent a flush induced by a specific trigger (hot water) in controlled condition;
− to demonstrate that CD07805/47 0.5% gel is able to prevent a flush whatever the trigger in everyday life condition;
− to investigate if reduction in redness is associated with a decrease in skin sensations such as heat, burning/stinging, skin tension and sweating;
− to demonstrate that such efficacy on transient redness and sensations takes place in both populations (rosacea type I and rosacea type II).
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. The subject is a male or female, who is at least 18 years of age or older at Screening visit.
2. The subject has a clinical diagnosis of mild to moderate erythemato-telangiectatic rosacea (ETR) or mild to moderate papulo-pustular rosacea (PPR) according to the National Rosacea Society grading (Wilkin et al., 2004).
3. The subject had at least five flushing episodes during the last week before Screening and Baseline visits |
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E.4 | Principal exclusion criteria |
1. The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin), or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus or actinic telangiectasia;
2. The subject has current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists;
3.The subject has less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents;
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy:
Total number of flushes for each 2-week period |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Period 1
- Evaluation of the face skin perfusion
- Evaluation of evolution of a* parameter
- Erythema evaluation by the investigator or designee
- Flushing sensations evaluation (heat, burning/stinging, skin tension and sweating)by the subjects
Period 2
- Redness self-evaluation by the subjects
- Flushing sensations evaluation (heat, stinging/burning, skin tension and sweating) by the subjects
- Frequency, duration, severity and embarrassment of flushing episodes by a self-evaluations questionnaire
Others:
- Dermatology Life Quality Index (DLQI)
- Rosacea clinical score
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Period 1:
Baseline (Day 1), Day 3 and Day 5
Period 2:
From Day 8 to Day 35
Others:
- at Baseline, Day 22 and Day 36
- at Screening, Baseline, Day 22 and Day 36 |
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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 | 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 | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
single-centre / Intra-individual |
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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 | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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 | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |