Flushing related to erythematotelangiectatic or papulopustular rosacea MedDRA version: 16.1 Level: PT Classification code 10016825 Term: Flushing System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Product Code: CD07805/47
Pharmaceutical Form: Gel
INN or Proposed INN: BRIMONIDINE TARTRATE
CAS Number: 70359-46-5
Current Sponsor code: CD07805/47
Concentration unit: % percent
Concentration type: eq
Sponsors
Galderma R&D SNC
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - 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). ;Secondary Objective: Not Applicable;Primary end point(s): Efficacy: Total number of flushes for each 2-week period;Timepoint(s) of evaluation of this end point: Day 22 + Day 36/ET | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;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 | — |
Countries
Germany
Contacts
Public ContactCTA Coordinator
Galderma R&D SNC
Outcome results
None listed