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Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Papulopustular Rosacea

Intervention: Azelaic acid (Finacea, BAY39-6251) (Drug); Metronidazole (Metrogel) (Drug); Doxycycline (Oracea) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

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

Summary

Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus an anti-inflammatory dose of doxycyline (40mg) daily or with metronidazole 1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at total of twelve weeks to determine the rapidity of improvement, and the length of time to reach 25%, 50% and 75% clearing compared to baseline.

Clinical Details

Official title: An Exploratory, Multicenter, Investigator-blinded, Active-controlled Study to Investigate the Efficacy of Topical Azelaic Acid (AzA)15% Gel Twice Daily or Metronidazole Topical Gel 1% Once Daily, Plus Anti-inflammatory Dose Doxycycline (40mg) Once Daily in Subjects With Moderate Papulopustular Rosacea

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

Primary outcome: Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)

Secondary outcome:

Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)

Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)

Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)

Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)

Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)

Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)

Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2

Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4

Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6

Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8

Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12

Investigator Rating of Overall Improvement at End of Study (Week 12)

Patient Rating of Overall Improvement at End of Study (Week 12)

Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)

Detailed description: The change in inflammatory lesion count will be assessed at each post-baseline visit by an analysis of variance model (ANOVA) with factors treatment and center, but not including treatment-by-center interaction.

Investigator's Global Assessment (IGA) of papulopustular rosacea (static score): 0 - Clear

(Virtually no rosacea ie, no papules and/or pustules; no or residual erythema; no or mild to

moderate degree of telangiectasia may be present); 1 - Minimal (Rare papules and/or

pustules; residual to mild erythema; mild to moderate degree of telangiectasia may be

present); 2 - Mild (Few papules and/or pustules; mild erythema; mild to moderate degree of

telangiectasia may be present); 3 - Mild to moderate (Distinct number of papules and/or

pustules; mild to moderate erythema; mild to moderate degree of telangiectasia may be

present); 4 - Moderate (Pronounced number of papules and/or pustules; moderate erythema;

mild to moderate degree of telangiectasia may be present); 5 - Moderate to severe (Many

papules and/or pustules, occasionally with large inflamed lesions; moderate erythema;

moderate degree of telangiectasia may be present); 6 - Severe (Numerous papules and/or

pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe degree of telangiectasia may be present).

Eligibility

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

Criteria:

Inclusion Criteria:

- Moderate papulopustular rosacea (IGA>4) with a minimum of 10 and no more than 50

inflammatory lesions and persistent erythema with or without telangiectasia Exclusion Criteria:

- Sensitivity to any of the treatments used

- Co-existing conditions that would unfavorably influence the course of the disease

- Pregnant or lactating women

- Severe rosacea

Locations and Contacts

Birmingham, Alabama 35233, United States

Denver, Colorado 80209, United States

West Palm Beach, Florida 33401, United States

Boston, Massachusetts 02114-2517, United States

Warren, Michigan 48088, United States

Fridley, Minnesota 55432, United States

Henderson, Nevada 89052, United States

Albuquerque, New Mexico 87106, United States

Stony Brook, New York 11790, United States

Mason, Ohio 45040, United States

Portland, Oregon 97223, United States

Austin, Texas 78759, United States

Dallas, Texas 75246, United States

Houston, Texas 77056, United States

San Antonio, Texas 78229, United States

Salt Lake City, Utah 84124, United States

Norfolk, Virginia 23507, United States

Additional Information

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Starting date: February 2009
Last updated: January 29, 2014

Page last updated: August 23, 2015

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