Effect of CD07805/47 Gel in Rosacea Flushing
Rosacea
About this trial
This is an interventional treatment trial for Rosacea
Eligibility Criteria
Inclusion Criteria:
- The subject is a male or female, who is at least 18 years of age or older at Screening visit.
- The subject has a clinical diagnosis of mild to moderate erythemato-telangiectatic rosacea or mild to moderate papulo-pustular rosacea according to the National Rosacea Society grading (Wilkin et al., 2004)
- The subject had at least five flushing episodes during the last week before Screening and Baseline visits
Exclusion Criteria:
- 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;
- The subject has current treatment with monoamine oxidase inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists;
- The subject has less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents;
Sites / Locations
- Galderma Investigational site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo
Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo
CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47
Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47
Period 1: Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3. Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design) Period 2 (cross-over design): Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks
Period 1: Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3. Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design). Period 2 (cross-over design): Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks.
Period 1: Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3. Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design). Period 2 (cross-over design): Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks.
Period 1: Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3. Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design). Period 2 (cross-over design): Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks.