Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea

Rosacea Clinical Trial

Official title:

A Multicenter, Randomized, Controlled, Double-masked, Crossover Design Study to Compare Efficacy and Assess Safety of CD07805/47 Gel 0.5% Applied Once Daily vs Azelaic Acid Gel 15% Applied Twice Daily in Subjects With Erythema of Rosacea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01659853
• Other study ID #: US10219
• Status: Completed
• Phase: Phase 3
• Start date: September 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2014
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily in subjects with moderate to severe facial erythema of rosacea.

Description:

Adult subjects with moderate to severe facial erythema of rosacea who meet inclusion/exclusion criteria will be randomized at Baseline/Visit 1 in a 1:1 ratio to receive either CD07805/47 gel 0.5% once daily or azelaic acid gel 15% twice daily for 15 days. Following an appropriate washout period, subjects will then switch treatments and use the second investigational product as instructed for 15 days (according to the subject's randomization scheme). Subjects will re-qualify based upon inclusion/exclusion prior to Period 2 treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is male or female aged 18 years or older.

2. Subject has a clinical diagnosis of facial rosacea.

3. Subject has a clinician's assessment score of moderate to severe erythema prior to enrollment.

4. Subject has a self assessment score of moderate to severe redness prior to enrollment.

5. Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment.

Exclusion Criteria:

1. Female subjects who are pregnant, nursing or planning a pregnancy during the study.

2. Subjects with a condition or who are in a situation, which in the Investigator's opinion may put a subject at risk, may confound study results, or may interfere with a subject's participation in the study.

3. Subjects with conditions causing facial erythema which would confound the assessment of treatment.

4. Subjects who are taking or have recently taken medications known to have interactions with a2-adrenergic agonists.

5. Subjects with known allergies or sensitivities to one of the components of the investigational products.

Related Conditions & MeSH terms

• Erythema
• Rosacea

Intervention

Drug:
• CD07805/47 gel 0.5%/CD07805/47 Vehicle
To maintain masking, CD07805/47 gel 0.5% will be administered along with CD07805/47 gel vehicle. During each treatment period (baseline to Day 15): CD07805/47 gel 0.5%, topical, once daily and CD07805/47 gel vehicle, topical, once daily
• azelaic acid gel 15%
During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily

Locations

Country	Name	City	State
United States	DermResearch, Inc	Austin	Texas
United States	Hudson Dermatology	Evansville	Indiana
United States	Dermatology Specialists Research, LLC	Louisville	Kentucky
United States	The Education & Research Foundation, Inc.	Lynchburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Success	Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period	Hour 6 on Day 15
Secondary	Onset of Action	Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application	30 minutes after baseline treatment application on Day 15