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| Sponsor: | Galderma |
|---|---|
| Information provided by: | Galderma |
| ClinicalTrials.gov Identifier: | NCT00989014 |
Purpose
This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication.
| Condition | Intervention | Phase |
|---|---|---|
|
Erythematotelangiectatic Rosacea |
Drug: CD07805/47 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety Study |
| Official Title: | Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Dose-Finding Study Investigating the Pharmacodynamics and Safety of Three Concentrations of CD07805/47 Topical Gel (0.07%, 0.18%, and 0.50%), Applied in Subjects With Moderate to Severe Erythematotelangiectatic Rosacea |
| Estimated Enrollment: | 112 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
CD07805/47 0.5% Topical Gel: Experimental
0.5% Topical Gel
|
Drug: CD07805/47
0.5% Topical Gel
|
|
CD07805/47 0.18% Topical Gel: Experimental
0.18% Topical Gel
|
Drug: CD07805/47
0.18% Topical Gel
|
|
CD07805/47 0.07% Topical Gel: Experimental
0.07% Topical Gel
|
Drug: CD07805/47
0.07% Topical Gel
|
|
CD07805/47 Vehicle Topical Gel: Placebo Comparator
Vehicle Topical Gel
|
Drug: CD07805/47
Vehicle Topical Gel
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Matthew Leoni, MD | matthew.leoni@galderma.com |
| United States, Arkansas | |
| Burke Pharmaceutical Research | Recruiting |
| Hot Springs, Arkansas, United States, 71913 | |
| Contact: Tim Dugan 501-620-4449 | |
| Principal Investigator: Dowling Stough, MD | |
| United States, Pennsylvania | |
| Philadephia Institute of Dermatology | Recruiting |
| Fort Washington, Pennsylvania, United States, 19034 | |
| Contact: Donna Keenan 215-836-7900 | |
| Principal Investigator: Andrew Pollack, MD | |
| United States, Texas | |
| Derm Research, Inc | Recruiting |
| Austin, Texas, United States, 78759 | |
| Contact: Amber Boykin 512-349-9889 | |
| Principal Investigator: Michael Jarratt, MD | |
| J&S Studies | Recruiting |
| College Station, Texas, United States, 77845 | |
| Contact: Jeremy Scott 979-774-5933 | |
| Principal Investigator: Terry Jones, MD | |
| United States, Virginia | |
| The Education & Research Foundation | Recruiting |
| Lynchburg, Virginia, United States, 24501 | |
| Contact: Sue Foster 434-847-8400 | |
| Principal Investigator: Kappa Meadows, MD | |
| Study Director: | Michael Graeber, MD | Galderma |
More Information
| Responsible Party: | Head of Global Clinical Project Management and US Development ( Michael Graeber MD ) |
| Study ID Numbers: | RD.06.SPR.18144 |
| Study First Received: | September 30, 2009 |
| Last Updated: | October 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00989014 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Erythematotelangiectatic Rosacea |
|
Rosacea Skin Diseases |