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

NCT00617903 | Completed Phase 2 Results

• 1 other identifier: 1402140
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Papulopustular Rosacea

Keywords

rosacea; papulopustular; azelaic acid; foam

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (16)

• 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)

  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)

  Baseline and Weeks 4, 8, 12 and End of Study (LOCF)

Study Arms (2)

Azelaic acid foam, 15% (BAY39-6251)

EXPERIMENTAL

Participants received azelaic acid foam, 15% topically twice daily for 12 weeks

Drug: Azelaic acid

Vehicle foam

PLACEBO COMPARATOR

Participants received vehicle foam topically twice daily for 12 weeks

Drug: Vehicle foam

Interventions

Azelaic acid DRUG

15% foam to be applied topically twice daily

Azelaic acid foam, 15% (BAY39-6251)

Vehicle foam DRUG

Active-ingredient-free vehicle to be applied topically twice daily

Vehicle foam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead
• Bayer: collaborator

Study Sites (7)

Unknown Facility

Denver, Colorado, 80209, United States

Location

Unknown Facility

Olathe, Kansas, 66062, United States

Location

Unknown Facility

Henderson, Nevada, 89052, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87106, United States

Location

Unknown Facility

Mason, Ohio, 45040, United States

Location

Unknown Facility

Austin, Texas, 78759, United States

Location

Unknown Facility

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

azelaic acid

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 18, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: April 7, 2020
• Results First Posted: July 4, 2013

Record last verified: 2013-12

Locations

US (7)