Clinical trial NCT01025635: Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea
Official title: Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-group Study to Investigate Safety and Efficacy of Azelaic Acid Foam, 15% Topically Applied Twice Daily in Subjects With Papulopustular Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Papulopustular Rosacea
Keywords: rosacea
papulopustular
azelaic acid
foam
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2009-12-03
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Diagnosis of papulopustular rosacea (IGA score of moderate or severe) with a minimum of 12 and maximum of 50 inflammatory lesions (papules and/or pustules) and persistent erythema with or without telangiectasia
* Free of any clinically significant disease which could interfere with the study
* Willingness to follow all study procedures
* Male or female patient at least 18 years of age

Exclusion Criteria:

* Subjects known to be non-responders to azelaic acid
* Presence of dermatoses that might interfere with the rosacea diagnosis or the evaluation of treatment results
* Ocular rosacea, phymatous rosacea
* Any condition or therapy that in the opinion of the investigator may pose a risk to the patient of interfere with any evaluation in the study
* Facial laser surgery in the 6 weeks prior to the study
* Topical or systemic use of prescription or non-prescription medications to treat rosacea
* Use of any agent other than the investigational drugs to treat rosacea during the study
* Expected use or change in dose in the 90 days prior to the study of beta-blockers, vasodilators, NSAIDs, hormonal treatment or drugs causing acneiform eruptions
* Known hypersensitivity to any ingredients of the investigational product formulation
* Alcohol or drug abuse
* Incapability of giving fully informed consent
* Subject is dependent person, i.e., a relative/family member of the investigator and/or is a member of the investigator's staff
* Participation in another clinical research study within the last 4 weeks before randomization in this study

Primary outcomes:
measure: Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)
timeFrame: At End of treatment (up to 12 weeks) (LOCF)
measure: Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)
timeFrame: Baseline and End of treatment (up to 12 weeks) (LOCF)
Secondary outcomes:
measure: Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)
timeFrame: At End of treatment (up to 12 weeks) (LOCF)
measure: Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF)
timeFrame: At End of treatment (up to 12 weeks) (LOCF)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Fremont
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Miramar
country: United States
state: Florida
city: Omaha
country: United States
state: Nebraska
city: Albuquerque
country: United States
state: New Mexico
city: High Point
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Johnston
country: United States
state: Rhode Island
city: Simpsonville
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Draelos ZD, Elewski B, Staedtler G, Havlickova B. Azelaic acid foam 15% in the treatment of papulopustular rosacea: a randomized, double-blind, vehicle-controlled study. Cutis. 2013 Dec;92(6):306-17.