check_circleStudy Completed

Acne Vulgaris

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.

Key Participants Requirements

Sex

Both

Age

12 Years

Trial summary

Enrollment Goal
879
Trial Dates
January 2002 - July 2002
Phase
Phase 3
Could I Receive a placebo
No
Products
Finacea (Azelaic Acid, BAY39-6251)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Dermatology Clinical Research CenterSan 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 CenterBoulder, 80304, United States
Completed
J & S Studies, Inc.Byran, 77802, United States
Completed
Seattle Women's: Health, Research, GynecologySeattle, 98105, United States
Completed
Meda Phase Inc.Newnan, 30263, United States
Completed
Dermatology Research Associates, Inc.Cincinnati, 45230, United States
Completed
Oregon Medical Research CenterPortland, 97223-6683, United States
Completed
Compliant Clinical Research, Inc.Wichita, 67206, United States
Completed
Coastal Clinical Research, IncMobile, 36608, United States
Completed
Medical & Clinical Research AssociatesBayshore, 11706, United States
Completed
Compliant Clinical Research, Inc.Shawnee, 66203, United States
Completed
Dermatology Associates of KnoxvilleKnoxville, 37922, United States
Completed
Pennsylvania State University College of MedicineHershey, 17033, United States
Completed
Academic Dermatology AssociatesAlbuquerque, 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 acne
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Investigators rating of overall improvement and patients self assessment of overall improvement and cosmetic acceptability
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Adverse event reports and patient's opinion on local tolerability of the study gels at the end of study
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A 12-week, Randomized, Double-blind, Multicenter Study Comparing the Clinical Efficacy and Safety of Azelaic Acid 15% Gel (SH H 655 BA) With Its Vehicle (SH H 655 PBA) in Patients With Mild to Moderate Acne.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2