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

Papulopustular Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00617903
• Other study ID #: 1402140
• Status: Completed
• Phase: Phase 2
• Start date: January 2008
• Est. completion date: June 2008

Study information

• Verified date: December 2013
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Papulopustular Rosacea
• Rosacea

Intervention

Drug:
• Azelaic acid
15% foam to be applied topically twice daily
• Vehicle foam
Active-ingredient-free vehicle to be applied topically twice daily

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
LEO Pharma	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12		Baseline and Weeks 4, 8 and 12
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)