Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea

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

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.

Study Overview

• Status: Completed
• Conditions: Papulopustular Rosacea
• Intervention / Treatment: Drug: Azelaic acid; Drug: Vehicle foam

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80209
  • Kansas
    • Olathe, Kansas, United States, 66062
  • Nevada
    • Henderson, Nevada, United States, 89052
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
  • Ohio
    • Mason, Ohio, United States, 45040
  • Texas
    • Austin, Texas, United States, 78759
  • Virginia
    • Norfolk, Virginia, United States, 23507

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Azelaic acid foam, 15% (BAY39-6251); Participants received azelaic acid foam, 15% topically twice daily for 12 weeks	Drug: Azelaic acid; 15% foam to be applied topically twice daily
Placebo Comparator: Vehicle foam; Participants received vehicle foam topically twice daily for 12 weeks	Drug: Vehicle foam; Active-ingredient-free vehicle to be applied topically twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)		Baseline and End of Study (Week 12)
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF)	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).	At End of Study (Week 12)
Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)	Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe	Baseline and End of Study (Week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)		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		Baseline and 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)		Baseline and 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)	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).	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)	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).	Baseline and 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)	Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe	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)	Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe	Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12	Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe	Baseline and Weeks 4, 8 and 12
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)	Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe	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)	Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe	Baseline and 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)	Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe	Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
Investigator's Rating of Overall Improvement at End of Study	Investigator's rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 - deterioration	At End of Study (Week 12)
Patients' Rating of Overall Improvement at End of Study	Patient's rating of overall improvement: 1 - excellent; 2 - good; 3 - fair; 4 - no improvement; 5 - worse	At End of Study (Week 12)
Patients' Opinion on Cosmetic Acceptability at End of Study	Patient's opinion on cosmetic acceptability: 1 - very good; 2 - good; 3 - satisfactory; 4 - poor; 5 - no opinion	At End of Study (Week 12)
Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success was defined as an IGA score of clear or minimal (0 to 1).").	At Weeks 4, 8 and 12
Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)	IGA based Patient response was defined as an IGA score of clear, minimal or mild (0, 1, 2).	At Weeks 4, 8, 12 and End of Study (LOCF)

Collaborators and Investigators

• Sponsor: LEO Pharma
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: January 22, 2008
• First Submitted That Met QC Criteria: February 15, 2008
• First Posted (Estimate): February 18, 2008

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: rosacea; azelaic acid; foam; papulopustular
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Antineoplastic Agents; Dermatologic Agents; Azelaic acid
• Other Study ID Numbers: 1402140