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

NCT01659853 | Completed Phase 3 Results

• 1 other identifier: US10219
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

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.

Conditions

Erythema; Rosacea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Onset of Action

  30 minutes after baseline treatment application on Day 15

Study Arms (1)

Overall Study

EXPERIMENTAL

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).

Drug: CD07805/47 gel 0.5%/CD07805/47 Vehicle; Drug: azelaic acid gel 15%

Interventions

CD07805/47 gel 0.5%/CD07805/47 Vehicle 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

Also known as: brimonidine tartrate gel 0.5%, brimonidine tartrate gel vehicle

Overall Study

azelaic acid gel 15% DRUG

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

Also known as: Finacea® gel 15%

Overall Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or female aged 18 years or older.
• Subject has a clinical diagnosis of facial rosacea.
• Subject has a clinician's assessment score of moderate to severe erythema prior to enrollment.
• Subject has a self assessment score of moderate to severe redness prior to enrollment.
• Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment.

You may not qualify if:

• Female subjects who are pregnant, nursing or planning a pregnancy during the study.
• 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.
• Subjects with conditions causing facial erythema which would confound the assessment of treatment.
• Subjects who are taking or have recently taken medications known to have interactions with α2-adrenergic agonists.
• Subjects with known allergies or sensitivities to one of the components of the investigational products.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (4)

Hudson Dermatology

Evansville, Indiana, 47714, United States

Location

Dermatology Specialists Research, LLC

Louisville, Kentucky, 40202, United States

Location

DermResearch, Inc

Austin, Texas, 78759, United States

Location

The Education & Research Foundation, Inc.

Lynchburg, Virginia, 24501, United States

Location

MeSH Terms

Conditions

Erythema; Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

A significant period effect was observed for CEA indicating there was carryover from period 1 to period 2. Therefore, as stated a priori in the protocol, only data from period 1 were used to analyze efficacy. All safety data are reported.

Results Point of Contact

• Title: Dr. Warren Winkelman
• Organization: Galerma Laboratories

warren.winkelman@galderma.com

817-961-5494

Study Officials

• Ronald W. Gottschalk, MD

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: August 8, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 25, 2022
• Results First Posted: July 10, 2014

Record last verified: 2014-03

Locations

US (4)