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Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in 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 (Drug); Vehicle foam (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bayer

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

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.

Clinical Details

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

Primary outcome:

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)

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

Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)

Secondary outcome:

Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)

Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12

Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)

Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)

Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)

Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)

Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)

Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12

Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)

Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)

Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)

Investigator's Rating of Overall Improvement at End of Study

Patients' Rating of Overall Improvement at End of Study

Patients' Opinion on Cosmetic Acceptability at End of Study

Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12

Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)

Eligibility

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

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

Locations and Contacts

Denver, Colorado 80209, United States

Olathe, Kansas 66062, United States

Henderson, Nevada 89052, United States

Albuquerque, New Mexico 87106, United States

Mason, Ohio 45040, United States

Austin, Texas 78759, United States

Norfolk, Virginia 23507, 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.

Starting date: January 2008
Last updated: December 26, 2013

Page last updated: August 20, 2015

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