Clinical trial NCT01555463: Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea
Official title: A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-group Clinical Trial to Assess the Safety and Efficacy of Azelaic Acid Foam, 15% Topically Applied Twice Daily for 12 Weeks in Subjects With Papulopustular Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Papulopustular Rosacea
Keywords: Rosacea
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2012-03-15
Enrollment: 961
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: The purpose of this study is to assess the safety and efficacy of azelaic acid (AzA) foam, 15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea compared to its vehicle.

Detailed description: To determine the efficacy of AzA foam, 15% compared to vehicle topically applied twice daily in papulopustular rosacea evaluated by therapeutic success rate according to Investigators Global Assessment (IGA) and change in inflammatory lesion count from baseline to end of treatment.

Evaluation of all adverse events will be covered in Adverse Events section.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of papulopustular rosacea
* Free of any clinically significant disease, which could interfere with the study
* Male or female subject aged ≥ 18 years
* Willingness of subject to follow all study procedures
* Signed written informed consent before any study-related activities are carried out

Exclusion Criteria:

* Subjects who are known to be non-responders to azelaic acid
* Presence of dermatoses that might interfere with rosacea diagnosis
* Ocular rosacea; phymatous rosacea; subjects with plaque-type rosacea lesions, papulopustular rosacea that requires systemic treatment
* Topical use of any prescription or non-prescription medication to treat rosacea within 6 weeks prior to randomization and throughout the study
* Systemic use of any prescription or non-prescription medication to treat rosacea (Retinoids within 6 months, Tetracycline within 2 months, Corticosteroids, erythromycin, azithromycin, and/or metronidazole within 4 weeks) prior to randomization and throughout the study
* Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to randomization
* Known hypersensitivity to any ingredients of the investigational product formulation
* Participation in another clinical research in parallel or within the last 4 weeks before randomization in this study
* Any condition or therapy that in the investigator's opinion may pose a risk to the subject or that could interfere with any evaluation in the 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 (LOCF), up to 12 weeks
measure: Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF)
timeFrame: Baseline and end of treatment (LOCF), up to 12 weeks
Secondary outcomes:
measure: Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF)
timeFrame: Baseline and end of treatment (LOCF), up to 12 weeks
measure: Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF)
timeFrame: At end of treatment (LOCF), up to 12 weeks
measure: Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF)
timeFrame: Baseline and end of treatment (LOCF), up to 12 weeks
measure: Percentage of Participants With Investigator's Global Assessment (IGA) Scores at End of Treatment (LOCF)
timeFrame: At end of treatment (LOCF), up to 12 weeks
measure: Nominal Value of Inflammatory Lesion Count at End of Treatment (LOCF)
timeFrame: At end of treatment (LOCF), up to 12 weeks
measure: Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF)
timeFrame: At end of treatment (LOCF), up to 12 weeks
measure: Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF)
timeFrame: Baseline and end of treatment (LOCF), up to 12 weeks
measure: Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF)
timeFrame: At end of treatment (LOCF), up to 12 weeks
measure: Participants' Global Assessment of Treatment Response at End of Treatment
timeFrame: At end of treatment, up to 12 weeks
measure: Participants' Global Assessment of Tolerability at End of Treatment
timeFrame: At end of treatment, up to 12 weeks
measure: Participants' Opinion on Cosmetic Acceptability at End of Treatment
timeFrame: At end of treatment, up to 12 weeks
measure: Participants' Opinion on Practicability of Product Use in Facial Areas Next to the Hairline at End of Treatment
timeFrame: At end of treatment, up to 12 weeks
measure: Change From Baseline in Rosacea Quality of Life (RosaQoL) Questionnaire at End of Treatment - Overall Quality of Life Score
timeFrame: Baseline and end of treatment, up to 12 weeks
measure: Number of Participants With Change From Baseline in Dermatology Life Quality Index (DLQI) Questionnaire at End of Treatment - Overall Score
timeFrame: Baseline and end of treatment, up to 12 weeks
measure: Change From Baseline in EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) at End of Treatment
timeFrame: Baseline and end of treatment, up to 12 weeks
measure: Change From Baseline in Index Value at End of Treatment
timeFrame: Baseline and end of treatment, up to 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Fremont
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Boynton Beach
country: United States
state: Florida
city: Boynton Beach
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miramar
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Saint Augustine
country: United States
state: Florida
city: Buffalo Grove
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Plainfield
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Richmond
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Warren
country: United States
state: Michigan
city: West Bloomfield
country: United States
state: Michigan
city: Fridley
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: East Windsor
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Johnston
country: United States
state: Rhode Island
city: Anderson
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: Webster
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Draelos ZD, Elewski BE, Harper JC, Sand M, Staedtler G, Nkulikiyinka R, Shakery K. A phase 3 randomized, double-blind, vehicle-controlled trial of azelaic acid foam 15% in the treatment of papulopustular rosacea. Cutis. 2015 Jul;96(1):54-61.