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

Information source: Galderma Laboratories, L.P.
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Erythema; Rosacea

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

Phase: Phase 3

Status: Recruiting

Sponsored by: Galderma Laboratories, L.P.

Official(s) and/or principal investigator(s):
Ronald W. Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, L.P.

Overall contact:
Jay H Mashburn, PhD, Phone: 817-961-5027, Email: jay.mashburn@galderma.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Composite Success

Secondary outcome: Onset of Action

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Jay H Mashburn, PhD, Phone: 817-961-5027, Email: jay.mashburn@galderma.com

Dermatology Specialists Research, LLC, Louisville, Kentucky 40202, United States; Recruiting
Lynn Fowler, Phone: 502-583-7546, Ext: 150
Joseph Fowler, MD, Principal Investigator

Melissa L.F. Knuckles MD, PSC, Richmond, Kentucky 40475, United States; Recruiting
Susan K. Roberts, Phone: 606-528-2881
Melissa Knuckles, MD, Principal Investigator

DermResearch, Inc, Austin, Texas 78759, United States; Recruiting
Martha Withers, Phone: 512-502-9324
Michael Jarratt, MD, Principal Investigator

The Education & Research Foundation, Inc., Lynchburg, Virginia 24501, United States; Recruiting
Sue Foster, Phone: 434-847-8400
Kappa Meadows, MD, Principal Investigator

Additional Information

Starting date: September 2012
Last updated: September 12, 2012

Page last updated: February 07, 2013

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