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

Papulopustular Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855595
• Other study ID #: 14366
• Secondary ID: 1402604256-0024
• Status: Completed
• Phase: Phase 4
• Start date: February 2009
• Est. completion date: July 2009

Study information

• Verified date: January 2014
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: July 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Papulopustular Rosacea
• Rosacea

Intervention

Drug:
• Azelaic acid (Finacea, BAY39-6251)
Participants received topical azelaic acid gel 15% twice daily for 12 weeks
• Metronidazole (Metrogel)
Participants received topical metronidazole 1% gel once daily for 12 weeks
• Doxycycline (Oracea)
Participants received systemic doxycycline 40 mg once daily for 12 week

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
LEO Pharma	Bayer

Country where clinical trial is conducted

United States, 

References & Publications (1)

Del Rosso JQ, Bruce S, Jarratt M, Menter A, Staedtler G. Efficacy of topical azelaic acid (AzA) gel 15% plus oral doxycycline 40 mg versus metronidazole gel 1% plus oral doxycycline 40 mg in mild-to-moderate papulopustular rosacea. J Drugs Dermatol. 2010 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Opinion of Local Tolerability		Week 12
Primary	Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)	NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)	Baseline and Week 2
Secondary	Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)		Week 2, 4, 6, 8 and 12
Secondary	Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)	NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)	Baseline and Week 4, 6, 8 and 12
Secondary	Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)	NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)	Baseline and Week 2, 4, 6, 8 and 12
Secondary	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)		Baseline and Weeks 2, 4, 6, 8 and 12
Secondary	Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Therapeutic success is defined as an IGA score of clear or minimal (0 or 1).	Weeks 2, 4, 6, 8 and 12
Secondary	Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Patient response is defined as an IGA score of clear, minimal, or mild (0, 1, or 2)	Weeks 2, 4, 6, 8 and 12
Secondary	Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).	At Week 2
Secondary	Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).	At Week 4
Secondary	Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).	At Week 6
Secondary	Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).	At Week 8
Secondary	Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).	At Week 12
Secondary	Investigator Rating of Overall Improvement at End of Study (Week 12)		Week 12
Secondary	Patient Rating of Overall Improvement at End of Study (Week 12)		Week 12
Secondary	Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)		Week 12