Clinical trial NCT01659853: Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
Official title: A Multicenter, Randomized, Controlled, Double-masked, Crossover Design Study to Compare Efficacy and Assess Safety of CD07805/47 Gel 0.5% Applied Once Daily vs Azelaic Acid Gel 15% Applied Twice Daily in Subjects With Erythema of Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erythema
Rosacea
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2012-08-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily in subjects with moderate to severe facial erythema of rosacea.

Detailed description: Adult subjects with moderate to severe facial erythema of rosacea who meet inclusion/exclusion criteria will be randomized at Baseline/Visit 1 in a 1:1 ratio to receive either CD07805/47 gel 0.5% once daily or azelaic acid gel 15% twice daily for 15 days. Following an appropriate washout period, subjects will then switch treatments and use the second investigational product as instructed for 15 days (according to the subject's randomization scheme). Subjects will re-qualify based upon inclusion/exclusion prior to Period 2 treatment.

Eligibility criteria: Inclusion Criteria:

1. Subject is male or female aged 18 years or older.
2. Subject has a clinical diagnosis of facial rosacea.
3. Subject has a clinician's assessment score of moderate to severe erythema prior to enrollment.
4. Subject has a self assessment score of moderate to severe redness prior to enrollment.
5. Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment.

Exclusion Criteria:

1. Female subjects who are pregnant, nursing or planning a pregnancy during the study.
2. Subjects with a condition or who are in a situation, which in the Investigator's opinion may put a subject at risk, may confound study results, or may interfere with a subject's participation in the study.
3. Subjects with conditions causing facial erythema which would confound the assessment of treatment.
4. Subjects who are taking or have recently taken medications known to have interactions with α2-adrenergic agonists.
5. Subjects with known allergies or sensitivities to one of the components of the investigational products.

Primary outcomes:
measure: Composite Success
timeFrame: Hour 6 on Day 15
Secondary outcomes:
measure: Onset of Action
timeFrame: 30 minutes after baseline treatment application on Day 15
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Hudson Dermatology
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialists Research, LLC
state: Kentucky
city: Austin
country: United States
facility: DermResearch, Inc
state: Texas
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc.
state: Virginia
Study officials:
affiliation: Galderma R&D
name: Ronald W. Gottschalk, MD
role: STUDY_DIRECTOR
References: