Clinical trial NCT00617903: Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea
Official title: A 12-week Exploratory, Multicenter, Double-blind, Vehicle-controlled Study to Investigate the Efficacy and Safety of Topical Azelaic Acid 15% Foam Twice Daily in Patients 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: 2008-02-18
Enrollment: 83
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 exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.


Eligibility criteria: Inclusion Criteria:

* male and female patient at least 18 years of age
* signed informed consent
* Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules and/or pustules, persistent erythema, and telangiectasia
* Ability and willingness to accept and comply with treatment and required medical examinations

Exclusion Criteria:

* Known non-responders to azelaic acid
* Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea
* Presence of dermatoses that could interfere with the rosacea diagnosis
* Treatment with isotretinoin in the six months prior to randomization
* Treatment of the face with topical retinoids during the two weeks prior to randomization
* Treatment with oral antibiotics during the four weeks prior to randomization
* Treatment with topical antibiotics
* Treatment with systemic corticosteroids during 4 weeks prior to randomization
* Treatment of the face with topical corticosteroids during 2 weeks prior to randomization
* Treatment of the face with topical imidazole antimycotics during 2 weeks prior to randomization
* Treatment of the face with topical azelaic acid formulations during 2 weeks prior to randomization
* Use of a sauna during 2 weeks prior to randomization and during the study
* Facial laser surgery for telangiectasia during 6 weeks prior to randomization
* Planned concurrent use of any treatment other than study medication that affects rosacea
* History of hypersensitivity to propylene glycol or any other ingredient of the study drugs
* Participation in another clinical trial during the last 4 weeks

Primary outcomes:
measure: Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward)
timeFrame: Baseline and End of Study (Week 12)
measure: Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF)
timeFrame: At End of Study (Week 12)
measure: Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)
timeFrame: Baseline and End of Study (Week 12)
Secondary outcomes:
measure: Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
timeFrame: At Weeks 4, 8, 12 and End of Study (LOCF)
measure: Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
timeFrame: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
measure: Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
timeFrame: At Weeks 4, 8, 12 and End of Study (LOCF)
measure: Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
timeFrame: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
measure: Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
timeFrame: At Weeks 4, 8, 12 and End of Study (LOCF)
measure: Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
timeFrame: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
measure: Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
timeFrame: At Weeks 4, 8, 12 and End of Study (LOCF)
measure: Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
timeFrame: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
measure: Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
timeFrame: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
measure: Investigator's Rating of Overall Improvement at End of Study
timeFrame: At End of Study (Week 12)
measure: Patients' Rating of Overall Improvement at End of Study
timeFrame: At End of Study (Week 12)
measure: Patients' Opinion on Cosmetic Acceptability at End of Study
timeFrame: At End of Study (Week 12)
measure: Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12
timeFrame: At Weeks 4, 8 and 12
measure: Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)
timeFrame: At Weeks 4, 8, 12 and End of Study (LOCF)
Other outcomes:
Locations:
city: Denver
country: United States
state: Colorado
city: Olathe
country: United States
state: Kansas
city: Henderson
country: United States
state: Nevada
city: Albuquerque
country: United States
state: New Mexico
city: Mason
country: United States
state: Ohio
city: Austin
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: