Phase 2
N=34
Effect of CD07805/47 Gel in Rosacea Flushing
Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT02300129 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Total Number of Flushes for Each 2-week Period — 15.3; 16.3 Flushes count — p=0.7420
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo (Drug); Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo (Drug); CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47 (Drug); Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Flushes for Each 2-week Period |
15.3; 16.3 | 0.7420 |
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
- 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;
Data sourced from ClinicalTrials.gov (NCT02300129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.