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Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Papulopustular Rosacea

Intervention: Azelaic acid foam, 15% (BAY39-6251) (Drug); Vehicle foam (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)

Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF)

Secondary outcome:

Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF)

Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF)

Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF)

Percentage of Participants With Investigator's Global Assessment (IGA) Scores at End of Treatment (LOCF)

Nominal Value of Inflammatory Lesion Count at End of Treatment (LOCF)

Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF)

Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF)

Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF)

Participants' Global Assessment of Treatment Response at End of Treatment

Participants' Global Assessment of Tolerability at End of Treatment

Participants' Opinion on Cosmetic Acceptability at End of Treatment

Participants' Opinion on Practicability of Product Use in Facial Areas Next to the Hairline at End of Treatment

Change From Baseline in Rosacea Quality of Life (RosaQoL) Questionnaire at End of Treatment - Overall Quality of Life Score

Number of Participants With Change From Baseline in Dermatology Life Quality Index (DLQI) Questionnaire at End of Treatment - Overall Score

Change From Baseline in EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) at End of Treatment

Change From Baseline in Index Value at End of Treatment

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Birmingham, Alabama 35209, United States

Birmingham, Alabama 35233, United States

Birmingham, Alabama 35243, United States

Fremont, California 94538, United States

Los Angeles, California 90045, United States

Sacramento, California 95816, United States

San Diego, California 92103, United States

San Francisco, California 94143-0660, United States

Santa Ana, California 92705, United States

Santa Monica, California 90404, United States

Colorado Springs, Colorado 80915, United States

Boynton Beach, Florida 33437, United States

Boynton Beach, Florida 33472-2952, United States

Jacksonville, Florida 32258, United States

Miami, Florida 33144, United States

Miami, Florida 33175, United States

Miramar, Florida 33027, United States

Ormond Beach, Florida 32174, United States

St. Augustine, Florida 32086, United States

Buffalo Grove, Illinois 60089, United States

Chicago, Illinois 60625, United States

Plainfield, Indiana 46168, United States

Louisville, Kentucky 40202, United States

Richmond, Kentucky 40475, United States

New Orleans, Louisiana 70124, United States

Warren, Michigan 48088, United States

West Bloomfield, Michigan 48322, United States

Fridley, Minnesota 55432, United States

St. Louis, Missouri 63141, United States

Omaha, Nebraska 68144, United States

Las Vegas, Nevada 89128, United States

Las Vegas, Nevada 89144, United States

East Windsor, New Jersey 08520, United States

New York, New York 10029, United States

Stony Brook, New York 11790, United States

Chapel Hill, North Carolina 27517, United States

Hickory, North Carolina 28602, United States

High Point, North Carolina 27262, United States

Raleigh, North Carolina 27612, United States

Winston-Salem, North Carolina 27103, United States

Johnston, Rhode Island 02919, United States

Anderson, South Carolina 29621, United States

Knoxville, Tennessee 37922, United States

Austin, Texas 78759, United States

Plano, Texas 75093, United States

Webster, Texas 77598, United States

Salt Lake City, Utah 84117, United States

Seattle, Washington 98101, United States

Spokane, Washington 99204, United States

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here and search for websynopsis results provided by Bayer

Starting date: September 2012
Last updated: January 25, 2015

Page last updated: August 20, 2015

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