Effect of CD07805/47 Gel in Rosacea Flushing
Condition: Rosacea
MeSH terms: Rosacea; Flushing
Intervention: 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
Intervention description: Period 1:
1g of CD07805/47 0.5% Gel on full face on Day 1 and 500mg on a half-face on Day 3.
500mg of Placebo Gel on a half-face on Day 3 and 1g on full face on Day 5.
Period 2:
1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks.
1g of Placebo Gel on full face once daily 7 days per week the 2 following weeks.; Period 1:
1g of Placebo Gel on full face on Day 1 and 500mg on a half-face on Day 3.
500mg of CD07805/47 0.5% Gel on a half-face on Day 3 and 1g on full face on Day 5.
Period 2:
1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks.
1g of Placebo Gel on full face once daily 7 days per week the 2 following weeks.; Period 1:
1g of CD07805/47 0.5% Gel on full face on Day 1 and 500mg on a half-face on Day 3.
500mg of Placebo Gel on a half-face on Day 3 and 1g on full face on Day 5.
Period 2:
1g of Placebo on full face once daily 7 days per week for 2 weeks.
1g of CD07805/47 0.5% Gel on full face once daily 7 days per week the 2 following weeks.; Period 1:
1g of Placebo Gel on full face on Day 1 and 500mg on a half-face on Day 3.
500mg of CD07805/47 0.5% Gel on a half-face on Day 3 and 1g on full face on Day 5.
Period 2:
1g of Placebo on full face once daily 7 days per week for 2 weeks.
1g of CD07805/47 0.5% Gel on full face once daily 7 days per week the 2 following weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase 2a study to assess the efficacy and safety of CD07805/47 0.5% gel in the prevention of
      the flush of rosacea.
    

Eligibility 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 or mild to moderate papulo-pustular rosacea 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

        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 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;