check_circleStudy Completed
Acne Vulgaris
Bayer Identifier:
90905
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne
Trial purpose
Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne.
Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits.
Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits.
Key Participants Requirements
Sex
BothAge
12 YearsTrial summary
Enrollment Goal
879Trial Dates
January 2002 - July 2002Phase
Phase 3Could I Receive a placebo
NoProducts
Finacea (Azelaic Acid, BAY39-6251)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Dermatology Clinical Research Center | San Antonio, 78229, United States |
Completed | Central Kentucky Research Associates, Inc. | Lexington, 40509, United States |
Completed | PMG Research of Winston-Salem, Inc. | Winston-Salem, 27103, United States |
Completed | Boulder Medical Center | Boulder, 80304, United States |
Completed | J & S Studies, Inc. | Byran, 77802, United States |
Completed | Seattle Women's: Health, Research, Gynecology | Seattle, 98105, United States |
Completed | Meda Phase Inc. | Newnan, 30263, United States |
Completed | Dermatology Research Associates, Inc. | Cincinnati, 45230, United States |
Completed | Oregon Medical Research Center | Portland, 97223-6683, United States |
Completed | Compliant Clinical Research, Inc. | Wichita, 67206, United States |
Completed | Coastal Clinical Research, Inc | Mobile, 36608, United States |
Completed | Medical & Clinical Research Associates | Bayshore, 11706, United States |
Completed | Compliant Clinical Research, Inc. | Shawnee, 66203, United States |
Completed | Dermatology Associates of Knoxville | Knoxville, 37922, United States |
Completed | Pennsylvania State University College of Medicine | Hershey, 17033, United States |
Completed | Academic Dermatology Associates | Albuquerque, 87106, United States |
Primary Outcome
- The nominal and percent change in lesions counts from baseline to last available visit (end of treatment) and treatment success rates based on Investigator's assessment of mild to moderate acnedate_rangeTime Frame:12 weeksenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Investigators rating of overall improvement and patients self assessment of overall improvement and cosmetic acceptabilitydate_rangeTime Frame:12 weeksenhanced_encryptionNoSafety Issue:
- Adverse event reports and patient's opinion on local tolerability of the study gels at the end of studydate_rangeTime Frame:12 weeksenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2