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Completed

NCT Number: NCT00617903

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

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Key information

Conditions

Papulopustular Rosacea Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azelaic acid

Drug

15% foam to be applied topically twice daily

Vehicle Foam

Drug

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

Primary outcomes

  1. 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)

    Time frame: Baseline and End of Study (Week 12)

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

    Time frame: At End of Study (Week 12)

    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).

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

    Time frame: Baseline and End of Study (Week 12)

    Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe

Secondary outcomes

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

    Time frame: At Weeks 4, 8, 12 and End of Study (LOCF)

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

    Time frame: Baseline and Weeks 4, 8 and 12

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

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

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

    Time frame: 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).

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

    Time frame: Baseline and 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).

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

    Time frame: At Weeks 4, 8, 12 and End of Study (LOCF)

    Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe

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

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

    Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe

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

    Time frame: Baseline and Weeks 4, 8 and 12

    Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe

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

    Time frame: At Weeks 4, 8, 12 and End of Study (LOCF)

    Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe

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

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

    Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe

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

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

    Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe

  12. Investigator's Rating of Overall Improvement at End of Study

    Time frame: At End of Study (Week 12)

    Investigator's rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 - deterioration

  13. Patients' Rating of Overall Improvement at End of Study

    Time frame: At End of Study (Week 12)

    Patient's rating of overall improvement: 1 - excellent; 2 - good; 3 - fair; 4 - no improvement; 5 - worse

  14. Patients' Opinion on Cosmetic Acceptability at End of Study

    Time frame: At End of Study (Week 12)

    Patient's opinion on cosmetic acceptability: 1 - very good; 2 - good; 3 - satisfactory; 4 - poor; 5 - no opinion

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

    Time frame: 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).").

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Collaborators

  • Bayer

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 18, 2008
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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