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

NCT ID: NCT01659853

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2012-12-31

Brief 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.

Detailed 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.

Conditions

Erythema; Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Overall Study

In this crossover study of CD07805/47 gel 0.5%/CD07805/47 Vehicle and azelaic acid gel 15%, 70 subjects were randomly assigned to treatment sequence.

During Period 1 (15 days), 35 subjects received topical CD07805/47 gel 0.5% in the morning and topical CD07805/47 gel vehicle in the evening, and 35 received topical azelaic acid gel twice daily according to FDA approved prescribing information. Subjects crossed over to the other treatment in Period 2 (15 days).

Group Type: EXPERIMENTAL

CD07805/47 gel 0.5%/CD07805/47 Vehicle

Intervention Type: DRUG

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%

Intervention Type: DRUG

During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily

Interventions

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

Intervention Type: DRUG

azelaic acid gel 15%

During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily

Intervention Type: DRUG

Other Intervention Names

brimonidine tartrate gel 0.5%; brimonidine tartrate gel vehicle; Finacea® gel 15%

Eligibility Criteria

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 α2-adrenergic agonists.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald W. Gottschalk, MD

Role: STUDY_DIRECTOR

Galderma R&D

Locations

Hudson Dermatology

Evansville, Indiana, United States

Dermatology Specialists Research, LLC

Louisville, Kentucky, United States

DermResearch, Inc

Austin, Texas, United States

The Education & Research Foundation, Inc.

Lynchburg, Virginia, United States

Countries

United States

Other Identifiers

US10219

Identifier Type: -

Identifier Source: org_study_id